MedPath

A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
Drug: Placebo
Registration Number
NCT03334435
Lead Sponsor
Eli Lilly and Company
Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.

Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1645
Inclusion Criteria
  • Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
  • Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
  • Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
  • Agree to use emollients daily.
Exclusion Criteria
  • Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.

  • A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.

  • Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.

  • Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).

  • Have been treated with the following therapies:

    • Monoclonal antibody for less than 5 half-lives prior to randomization.
    • Received prior treatment with any oral Janus kinase (JAK) inhibitor.
    • Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
    • Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
  • Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.

  • Have had major surgery within the past eight weeks or are planning major surgery during the study.

  • Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.

  • Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.

  • Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.

  • Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.

  • Have specific laboratory abnormalities.

  • Have received certain treatments that are contraindicated.

  • Pregnant or breastfeeding.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Responders and Partial Responders (RPR)-PlaceboBaricitinibResponders or partial responders (RPR) \[Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
Responders and Partial Responders (RPR)-PlaceboPlaceboResponders or partial responders (RPR) \[Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
RPR-Bari 2-mgBaricitinibRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.
RPR-Bari 4-mgBaricitinibRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.
NR: Placebo to Bari 2 mgPlaceboNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Placebo to Bari 4 mgPlaceboNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
PlaceboPlaceboParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.
RPR-Bari 1-milligram (mg)BaricitinibRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.
NR: Bari 1 mg to 4 mgBaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Non-responders (NR): Bari 1 mg to 2 mgBaricitinibNon-responder (NR) \[those not meeting definition of RPR\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Bari 2 mg to 2 mgBaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Bari 2 mg to 4 mgBaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
NR: Bari 4 mg to 4 mgBaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
NR: Placebo to Bari 2 mgBaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Placebo to Bari 4 mgBaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Bari 1 mgBaricitinibParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.
Bari 2 mgBaricitinibParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.
Bari 4 mgBaricitinibParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.
Bari 2-mg Open-Label AddendumBaricitinibParticipants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.
Primary Outcome Measures
NameTimeMethod
Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1Weeks 16, 36 and 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1Weeks 16, 36, and 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

Secondary Outcome Measures
NameTimeMethod
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2Weeks 16, 36, and 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2Weeks 16, 36, and 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2Weeks 16, 36 and 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2Weeks 16, 36, and 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1Weeks 16, 36, 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1Weeks 16, 36, and 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75Weeks 16, 36, and 52 Weeks

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.

RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75Weeks 16, 36, and 52

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.

NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75Weeks 16, 36, and 52

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.

NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75Weeks 16, 36, and 52

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.

RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS)Week 16

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.

RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRSWeek 16

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.

NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRSWeek 16

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.

NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRSWeek 16

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.

NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2Weeks 4, 16, 24, 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2Weeks 4, 16, 24, 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1Weeks 4, 16, 24, 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1Weeks 4, 16, 24, 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75Weeks 4, 16, 24, 52

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.

Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study)Week 52 Up to Week 200

Participants who entered the Substudy, relapsed with an IGA ≥3 and were retreated

NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75Weeks 4, 16, 24, 52

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.

NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRSWeek 16

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.

NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRSWeek 16

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.

Percentage of Participants Who Achieved a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)Weeks 68, 104

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Percentage of Participants Who Achieved a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)Weeks 68, 104

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)Weeks 68, 104

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.

Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)Weeks 68, 104

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)Weeks 68, 104

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Percentage of Participants With a Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization(Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering Substudy With IGA 0 or 1)Weeks 68, 104

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)Week 68

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Percentage of Participants With a Response of IGA 0 or 1 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)Week 68

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)Week 68

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy)Week 104

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy)Week 104

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy)Week 104

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Trial Locations

Locations (184)

Fremantle Dermatology

🇦🇺

Perth, Western Australia, Australia

Universitätsklinikum Heidelberg

🇩🇪

Heidelberg, Baden-Württemberg, Germany

SZTE AOK Borgyogyaszati es Allergologiai Klinika

🇭🇺

Szeged, Csongrad, Hungary

Clinica De Enfermedades Cronicas y Procedimientos Especiales

🇲🇽

Morelia, Michoacan Morelia, Mexico

DermoDent, Centrum Medyczne Czajkowscy

🇵🇱

Osielsko, Kujawsko-pomorskie, Poland

Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

🇵🇱

Olsztyn, Warminsko-mazurskie, Poland

NTT Medical Center Tokyo

🇯🇵

Shinagawa-KU, Tokyo, Japan

Allergo-Derm Bakos Kft

🇭🇺

Szolnok, Jasz-Nagykun-Szolnok, Hungary

RM Pharma Specialists S.A. de C.V.

🇲🇽

Distrito Federal, Mexico

NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

🇵🇱

Bialystok, Podlaskie, Poland

Chang Gung Memorial Hospital - Linkou

🇨🇳

Taoyuan, (r.o.c.), Taiwan

KH Hietzing mit neurologischem Zentrum Rosenhügel

🇦🇹

Wien, Austria

Sozialmed. Zentrum Ost - Donauspital

🇦🇹

Wien, Austria

Universitätsklinikum Freiburg

🇩🇪

Freiburg im Breisgau, Baden-Württemberg, Germany

Trial Pharma Kft.

🇭🇺

Puspokladany, Hajdu-Bihar, Hungary

Kaposi Mor Oktato Korhaz

🇭🇺

Kaposvar, Somogy, Hungary

UNO Medical Trials Kft.

🇭🇺

Budapest, Hungary

Seth GS Medical College & KEM Hospital

🇮🇳

Mumbai, Maharshtra, India

MedMare Bt

🇭🇺

Veszprem, Hungary

Universitätsspital Zürich

🇨🇭

Zürich, Switzerland

Taipei Medical University- Shuang Ho Hospital

🇨🇳

New Taipei City, Taiwan

Hosono Clinic

🇯🇵

Chuo-ku, Tokyo, Japan

Yamate Dermatological Clinic

🇯🇵

Shinjuku, Tokyo, Japan

Grupo Medico Camino S.C.

🇲🇽

México City, Distrito Federal, Mexico

CRI Centro Regiomontano de Investigacion S.C.

🇲🇽

Monterrey, Nuevo Leon, Mexico

Dermed Centrum Medyczne Sp. z o.o.

🇵🇱

Lodz, Lodzkie, Poland

LASER CLINIC Specjalistyczne Gabinety Lekarskie

🇵🇱

Szczecin, Zachodniopomorskie, Poland

HUG-Hôpitaux Universitaires de Genève

🇨🇭

Genève, Switzerland

National Cheng Kung University Hospital

🇨🇳

Tainan, Taiwan

Centrum Medyczne AMED

🇵🇱

Warszawa, Mazowieckie, Poland

Centrum Medyczne Evimed

🇵🇱

Warszawa, Mazowieckie, Poland

Chung Shan Medical University Hospital

🇨🇳

Taichung City, Taiwan

Tokyo Teishin Hospital

🇯🇵

Chiyoda-Ku, Tokyo, Japan

Hospital Universitario Dr. Jose Eleuterio Gonzalez

🇲🇽

Monterrey, Nuevo León, Mexico

The Skin Centre

🇦🇺

Benowa, Queensland, Australia

CEDIC-Centro de Investigaciones Clinicas

🇦🇷

Caba, Buenos Aires, Argentina

AKH

🇦🇹

Wien, Austria

Buenos Aires Skin

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Hopital Larrey

🇫🇷

Toulouse, France

Clinical Trials SA Pty Ltd

🇦🇺

Adelaide, South Australia, Australia

KA Rudolfstiftung

🇦🇹

Wien, Austria

Chru De Nantes Hotel-Dieu

🇫🇷

Nantes Cedex 1, France

Skin & Cancer Foundation Australia

🇦🇺

Westmead, New South Wales, Australia

Fakultni nemocnice Kralovske Vinohrady

🇨🇿

Praha 10, Hl. M. Praha, Czechia

Nemocnice Novy Jicin a.s.

🇨🇿

Novy Jicin, Moravskoslezsky Kraj, Czechia

Fundacion CIDEA

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Skin and Cancer Foundation Inc.

🇦🇺

Carlton, Victoria, Australia

Centre Hospitalier Lyon Sud

🇫🇷

Pierre Benite Cedex, France

Parra Dermatología

🇦🇷

Mendoza, Argentina

Universitätsklinikum Graz

🇦🇹

Graz, Steiermark, Austria

Woden Dermatology

🇦🇺

Phillip, Australian Capital Territory, Australia

Fakultni Nemocnice v Motole

🇨🇿

Praha 5, Hl. M. Praha, Czechia

Gemeinschaftspraxis Mahlow

🇩🇪

Blankenfelde-Mahlow, Brandenburg, Germany

Gentofte Hospital

🇩🇰

Hellerup, Region Hovedstaden, Denmark

All India Institue of Medical Sciences (AIIMS)

🇮🇳

New Delhi, Delhi, India

Panchshil Hospital

🇮🇳

Ahmedabad, Gujarat, India

King George Hospital

🇮🇳

Vizag, Andhra Pradesh, India

Sir Ganga Ram Hospital

🇮🇳

New Delhi, Delhi, India

Dr. D. Y. Patil Medical College & Hospital

🇮🇳

Navi Mumbai, Maharashtra, India

ULSS 8

🇮🇹

Vicenza, Italy

Policlinico di Tor Vergata

🇮🇹

Roma, Italy

Azienda Ospedaliera Universitaria Federico II

🇮🇹

Napoli, Italy

Policlinico Univ. Agostino Gemelli

🇮🇹

Roma, Lazio, Italy

Rambam Medical Center

🇮🇱

Haifa, Israel

Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

🇮🇹

Genova, Italy

Azienda Ospedaliera - Universitaria Pisana

🇮🇹

Pisa, Italy

Ospedale Policlinico Giambattista Rossi, Borgo Roma

🇮🇹

Verona, Italy

Hadassah Medical Center

🇮🇱

Jerusalem, Israel

Tel Aviv Sourasky Medical Center

🇮🇱

Tel Aviv, Israel

Hiroshima University Hospital

🇯🇵

Hiroshima-shi, Hiroshima-ken, Japan

Kawashima Dermatology Clinic

🇯🇵

Ichikawa-shi, Chiba, Japan

Severance Hospital Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

Iidabashi Clinic

🇯🇵

Chiyoda-ku, Tokyo, Japan

Gachon University Gil Medical Center

🇰🇷

Incheon, Korea, Korea, Republic of

Osaka City University Hospital

🇯🇵

Osaka, Japan

Queen's Square Dermatology and Allergology

🇯🇵

Nishi-ku, Yokohama-city, Kanagawa, Japan

Nihonbashi Sakura Clinic

🇯🇵

Chuo-ku, Tokyo, Japan

JM Research S.C.

🇲🇽

Cuernavaca, Mexico

Naoko Dermatology Clinic

🇯🇵

Setagaya-ku, Tokyo, Japan

Tachikawa Dermatology Clinic

🇯🇵

Tachikawa-shi, Tokyo, Japan

Ajou University Hospital

🇰🇷

Suwon, Gyeonggi Do, Korea, Republic of

Konkuk University Medical Center

🇰🇷

Seoul, Korea, Republic of

Sumire Dermatology Clinic

🇯🇵

Edogawa-ku, Tokyo, Japan

Hospital de Jesus I.A.P.

🇲🇽

Mexico City, Distrito Federal, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

🇲🇽

Durango, Mexico

Hallym University Kangnam Sacred Heart Hospital

🇰🇷

Seoul, Korea, Republic of

Oizumi Hanawa Clinic

🇯🇵

Nerima-ku, Tokyo, Japan

Shirasaki Clinic

🇯🇵

Takaoka-shi, Toyama, Japan

Dongguk University Ilsan Hospital

🇰🇷

Goyang, Gyeonggi-do, Korea, Republic of

Chungang University Hospital

🇰🇷

Seoul, Korea, Republic of

Centrum Badan Klinicznych, PI House

🇵🇱

Gdansk, Pomorskie, Poland

Lubelskie Centrum Diagnostyczne

🇵🇱

Swidnik, Lubelskie, Poland

Barbara Rewerska DIAMOND CLINIC

🇵🇱

Krakow, Malopolskie, Poland

Wojskowy Instytut Medyczny CSK MON

🇵🇱

Warsaw, Mazowieckie, Poland

Centralny Szpital Kliniczny MSWiA

🇵🇱

Warszawa, Mazowieckie, Poland

Centrum Medyczne Angelius Provita

🇵🇱

Katowice, Slaskie, Poland

GBUZ Clinical dermatology and venereological dispensary

🇷🇺

Krasnodar, Krasnodarskiy Kray, Russian Federation

Inselspital Bern

🇨🇭

Bern, Switzerland

LLC Medical Center "Kurator"

🇷🇺

Saint-Petersburg, Russian Federation

Hospital General Universitario Alicante

🇪🇸

Alicante, Spain

Hospital Universitario Ramon y Cajal

🇪🇸

Madrid, Spain

Hospital del Mar

🇪🇸

Barcelona, Spain

Hospital De Gran Canaria Dr. Negrin

🇪🇸

Las Palmas de Gran Canaria, Spain

Chang Gung Memorial Hospital - Kaohsiung

🇨🇳

Kaohsiung, Taiwan

National Taiwan University Hospital

🇨🇳

Taipei City, Taiwan

Hospital Infanta Leonor

🇪🇸

Madrid, Spain

Clinica Universitaria De Navarra

🇪🇸

Pamplona, Navarra, Spain

Hospital Germans Trias i Pujol

🇪🇸

Barcelona, Badalona, Spain

Centro de Especialidades Mollabao

🇪🇸

Pontevedra, Spain

Hospital Universitario Rey Juan Carlos

🇪🇸

Mostoles, Madrid, Spain

CHUV Centre Hospitalier Universitaire Vaudois

🇨🇭

Lausanne, Vaud, Switzerland

Chang Gung Memorial Hospital - Taipei

🇨🇳

Taipei City, Taiwan

Yanagihara dermatology clinic

🇯🇵

Ainokawa, Ichikawa-shi, Chiba, Japan

Shibaki Dermatology Clinic

🇯🇵

Sapporo, Hokkaido, Japan

Noguchi Dermatology

🇯🇵

Kashima-machi, Kamimashiki-gun, Kumamoto, Japan

Osaka Habikino Medical Center

🇯🇵

Habikino, Osaka, Japan

Yoshioka Dermatology Clinic

🇯🇵

Neyagawa-shi, Osaka, Japan

Nomura Dermatology Clinic

🇯🇵

Yokohama-shi, Kanagawa, Japan

Kyoto Prefectural University of Medicine

🇯🇵

Kyoto-shi, Kyoto, Japan

Kume Clinic

🇯🇵

Nishi-ku Sakai-shi, Osaka, Japan

Senri-Chuo Hanafusa Dermatology Clinic

🇯🇵

Toyonaka-shi, Osaka, Japan

Sanrui Dermatology Clinic

🇯🇵

Ohmiya-ku,Saitama-shi, Saitama, Japan

Jichi Medical University Hospital

🇯🇵

Shimotsuke, Tochigi, Japan

CHU de Bordeaux Hopital Saint Andre

🇫🇷

Bordeaux Cedex, France

Hopital Saint-Louis

🇫🇷

Paris, Cedex 10, France

SPb SBHI Skin-venerologic dispensary #10

🇷🇺

St. Petersburg, Russian Federation

Universitätsmedizin Göttingen

🇩🇪

Göttingen, Niedersachsen, Germany

Hospital Universitario 12 de Octubre

🇪🇸

Madrid, Spain

Hospital Universitario La Paz

🇪🇸

Madrid, Spain

Sheba Medical Center

🇮🇱

Ramat Gan, Israel

Veracity Clinical Research Pty Ltd

🇦🇺

Woolloongabba, Queensland, Australia

Instituto de Neumonología y Dermatología

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

🇦🇷

Buenos Aires, Argentina

Psoriahue Medicina Interdisciplinaria

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Ordensklinikum Linz GmbH - Elisabethinen

🇦🇹

Linz, Oberösterreich, Austria

Fakultni Nemocnice U svate Anny

🇨🇿

Brno, Jihomoravský Kraj, Czechia

Nemocnice Na Bulovce

🇨🇿

Praha 8, Hl. M. Praha, Czechia

Clintrial, s.r.o.

🇨🇿

Praha 10, Hl. M. Praha, Czechia

Fakultni Nemocnice Plzen

🇨🇿

Plzen-Bory, Plzeňský Kraj, Czechia

Kozni ambulance Kutna Hora, s.r.o.

🇨🇿

Kutna Hora, Středočeský Kraj, Czechia

Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

🇨🇿

Usti nad Labem, Ustecký Kraj, Czechia

Aarhus Universitehospital Marselisborg Centret

🇩🇰

Aarhus, Region Midtjyland, Denmark

CHU Grenoble Alpes

🇫🇷

Grenoble Cédex 9, France

CHU de Nice Hopital de L'Archet

🇫🇷

Nice cedex 3, France

Klinikum der Universität München

🇩🇪

München, Bayern, Germany

Dermatologisches Zentrum Osnabrück Nord

🇩🇪

Bramsche, Niedersachsen, Germany

Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

🇩🇪

Darmstadt, Hessen, Germany

Universitätsklinikum Otto-von-Guericke-Universität

🇩🇪

Magdeburg, Sachsen-Anhalt, Germany

Universitaetsklinikum Essen

🇩🇪

Essen, Nordrhein-Westfalen, Germany

Praxis Gerlach

🇩🇪

Dresden, Sachsen, Germany

Universitätsklinikum Carl Gustav Carus

🇩🇪

Dresden, Sachsen, Germany

Universitätsklinikum Schleswig-Holstein

🇩🇪

Lübeck, Schleswig-Holstein, Germany

Charité Universitätsmedizin Berlin

🇩🇪

Berlin, Germany

Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik

🇩🇪

Aachen, Germany

Rothhaar Studien GmbH

🇩🇪

Berlin, Germany

ISA GmbH

🇩🇪

Berlin, Germany

Praxis für Ganzheitliche Dermatologie im Ärztehaus

🇩🇪

Berlin, Germany

Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

🇭🇺

Debrecen, Hajdu-Bihar, Hungary

TFS Trial Form Support GmbH

🇩🇪

Hamburg, Germany

Oroshaza Varosi Onkormanyzat Korhaza

🇭🇺

Oroshaza, Bekes, Hungary

Markusovszky Korhaz

🇭🇺

Szombathely, Vas, Hungary

Haemek Medical Center- Dermatology

🇮🇱

Afula, Israel

Istituto Clinico Humanitas

🇮🇹

Rozzano, Milano, Italy

Rabin Medical Center

🇮🇱

Petach Tikva, Israel

Medical Corporation Soleil Miyata Dermatology Clinic

🇯🇵

Matsudo-shi, Chiba, Japan

Kurume University Hospital

🇯🇵

Kurume, Fukuoka, Japan

Fumimori Clinic

🇯🇵

Fukuoka-shi, Fukuoka, Japan

Tokyo Medical University Ibaraki Medical Center

🇯🇵

Inashiki-gun, Ibaraki, Japan

Shimane University Hospital

🇯🇵

Izumo, Shimane, Japan

JA Shizuoka Kohseiren Enshu Hospital

🇯🇵

Hamamatsu-shi, Shizuoka, Japan

Yamanashi Prefectural Central Hospital

🇯🇵

Kofu, Yamanashi, Japan

Gifu University Hospital

🇯🇵

Gifu, Japan

Korea University Ansan Hospital

🇰🇷

Ansan-si, Gyeonggi-do, Korea, Republic of

LLC ArsVitae NorthWest

🇷🇺

Saint-Petersburg, Russian Federation

Seoul St. Mary's Hospital

🇰🇷

Seoul, Korea, Republic of

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

🇩🇪

Frankfurt am Main, Hessen, Germany

Universität Leipzig - Universitätsklinikum

🇩🇪

Leipzig, Sachsen, Germany

Yokohama City Minato Red Cross Hospital

🇯🇵

Yokohama-shi, Kanagawa, Japan

Sapporo Skin Clinic

🇯🇵

Sapporo, Hokkaido, Japan

Universitätsmedizin Rostock

🇩🇪

Rostock, Mecklenburg-Vorpommern, Germany

Byramjee Jeejeebhoy Medical College & Civil Hospital

🇮🇳

Ahmedabad, Gujarat, India

Gandhi Hospital

🇮🇳

Secunderabad, Telangana, India

State scientific centre for dermatovenerology and cosmetolog

🇷🇺

Moscow, Russian Federation

Russian state medical-stomatological university n.a. Evdokimov

🇷🇺

Moscow, Russian Federation

© Copyright 2025. All Rights Reserved by MedPath