A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
- 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
- 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.
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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.
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A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
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Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
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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).
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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.
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Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
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Have had major surgery within the past eight weeks or are planning major surgery during the study.
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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.
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Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
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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.
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Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
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Have specific laboratory abnormalities.
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Have received certain treatments that are contraindicated.
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Pregnant or breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Responders and Partial Responders (RPR)-Placebo Baricitinib Responders 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)-Placebo Placebo Responders 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-mg Baricitinib RPR 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-mg Baricitinib RPR 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 mg Placebo NR 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 mg Placebo NR 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. Placebo Placebo Participants 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) Baricitinib RPR 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 mg Baricitinib NR 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 mg Baricitinib Non-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 mg Baricitinib NR 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 mg Baricitinib NR 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 mg Baricitinib NR 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 mg Baricitinib NR 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 mg Baricitinib NR 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 mg Baricitinib Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally. Bari 2 mg Baricitinib Participants 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 mg Baricitinib Participants 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 Addendum Baricitinib Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.
- Primary Outcome Measures
Name Time Method 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 1 Weeks 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 1 Weeks 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
Name Time Method RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 Weeks 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 2 Weeks 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 2 Weeks 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 2 Weeks 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 1 Weeks 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 1 Weeks 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)75 Weeks 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 75 Weeks 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 75 Weeks 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 75 Weeks 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 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.
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch 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.
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch 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.
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 Weeks 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 2 Weeks 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 1 Weeks 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 1 Weeks 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 75 Weeks 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 75 Weeks 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 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.
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch 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.
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