Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
- Conditions
- Dermatitis, AtopicEczemaSkin DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateDermatitisHypersensitivityGenetic Diseases, InbornSkin Diseases, GeneticImmune System Diseases
- Interventions
- Drug: Injectable PlaceboDrug: Oral Placebo
- Registration Number
- NCT03720470
- Lead Sponsor
- Pfizer
- Brief Summary
B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 838
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Male or female subjects aged 18 years or older at the time of informed consent
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Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
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Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.
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Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study
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Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
- Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
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Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure; or
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Other active nonAD inflammatory skin diseases or conditions affecting skin
- Prior treatment with JAK inhibitors
- Previous treatment with dupilumab
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg PF-04965842 100 mg Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20 PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg PF-04965842 200 mg Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20 Oral Placebo + Placebo Inj followed by 200 mg PF-04965842 PF-04965842 200 mg Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20 PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg Injectable Placebo Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20 Oral Placebo + Placebo Inj followed by 100 mg PF-04965842 Oral Placebo Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20 Oral Placebo + Placebo Inj followed by 200 mg PF-04965842 Oral Placebo Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20 Oral Placebo + Placebo Inj followed by 100 mg PF-04965842 PF-04965842 100 mg Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20 PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg Injectable Placebo Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20 Dupilumab Injection + Oral Placebo followed by Oral Placebo Oral Placebo Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20 Oral Placebo + Placebo Inj followed by 100 mg PF-04965842 Injectable Placebo Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20 Oral Placebo + Placebo Inj followed by 200 mg PF-04965842 Injectable Placebo Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20 Dupilumab Injection + Oral Placebo followed by Oral Placebo Dupilumab Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 Baseline, Week 12 EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12 Baseline (the last measurement prior to first dosing on Day 1), Week 12 IGA assessed severity of atopic dermatitis (AD) on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded scalp, palms and sole.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 Baseline, Week 2, 4, 8, 12 and 16 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
DLQI at Week 20 Week 20 DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16 Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 Baseline, Week 2, 4, 8 and 16 IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 Baseline, Week 2, 4, 8, 12 and 16 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 Baseline, Week 2, 4, 8 and 16 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
EQ-5D-5L- VAS Score at Week 20 Week 20 EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
POEM at Week 20 Week 20 POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.
Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 Baseline, Week 2, 4, 8,12 and 16 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS Baseline up to Week 16 Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 Baseline, Week 12 and 16 EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.
EQ-5D-5L- Index Value at Week 20 Week 20 EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 Baseline, Weeks 12 and 16 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Change From Baseline in HADS - Depression Scale at Week 12 and 16 Baseline, Week 12 and 16 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 Baseline, Week 2, 4, 8, 12 and 16 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Percentage BSA at Week 18 and 20 Week 18 and 20 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 Baseline, Week 2, 4, 8, 12 and 16 Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 Baseline, Week 12 and 16 EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 Baseline, Week 2, 4, 8 12 and 16 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 Baseline, Week 2, 12 and 16 DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
HADS - Depression Scale at Week 20 Week 20 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
PSAAD Total Score at Week 18 and 20 Week 18 and 20 PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
HADS - Anxiety Scale at Week 20 Week 20 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 Baseline, Week 1 to Week 16 PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 Baseline, Week 2, 4, 8 12 and 16 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 Baseline, Week 12 and 16 POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.
Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 Baseline, Week 2, 4, 8 12 and 16 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 Baseline up to Week 16 Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure.
SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 Week 18 and 20 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Trial Locations
- Locations (213)
Moonshine Research Center, Inc.
🇺🇸Doral, Florida, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
🇺🇸Cary, North Carolina, United States
Toronto Research Centre
🇨🇦Toronto, Ontario, Canada
Manna Research (Toronto)
🇨🇦Toronto, Ontario, Canada
Kume Clinic
🇯🇵Sakai, Osaka, Japan
Centro Medico SkinMed Limitada
🇨🇱Santiago, Region Metropolitana, Chile
Osaka Habikino Medical Center
🇯🇵Habikino, Osaka, Japan
Outpatient Clinic of Ventspils
🇱🇻Ventspils, Latvia
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
🇵🇱Czestochowa, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
🇵🇱Gdansk, Poland
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
🇵🇱Poznan, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
🇵🇱Wroclaw, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica
🇸🇰Kosice-Saca, Slovakia
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan (r.o.c), Taiwan
SANARE spol. s.r.o., Dermatovenerologicka ambulancia
🇸🇰Svidnik, Slovakia
CCR Prague, s.r.o.
🇨🇿Praha 3, Czechia
SMIQ. S. de R. L. de C.V.
🇲🇽Queretaro, Mexico
Medinova Research, South London Clinical Trial Centre
🇬🇧Sidcup, Kent, United Kingdom
Savin Medical Group LLC
🇺🇸Miami, Florida, United States
The University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
MedDerm Associates
🇺🇸San Diego, California, United States
Clinical Research Center of Alabama, LLC
🇺🇸Birmingham, Alabama, United States
Marvel Research, LLC
🇺🇸Huntington Beach, California, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
Allergy & Asthma Care Center of Southern California
🇺🇸Long Beach, California, United States
Allergy & Asthma Associates of Southern California dba Southern California Research
🇺🇸Mission Viejo, California, United States
Dermatology Specialists, Inc.
🇺🇸Murrieta, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Synexus Clinical Research US, Inc.
🇺🇸Anderson, South Carolina, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Renaissance Research and Medical Group, Inc
🇺🇸Cape Coral, Florida, United States
C & R Research Services USA, Inc
🇺🇸Coral Gables, Florida, United States
Florida Academic Centers Research and Education, LLC
🇺🇸Coral Gables, Florida, United States
Solutions Through Advanced Research, Inc.
🇺🇸Jacksonville, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Olympian Clinical Research
🇺🇸Largo, Florida, United States
Wellness Clinical Research, LLC
🇺🇸Miami Lakes, Florida, United States
Research Institute of Southeast, LLC
🇺🇸West Palm Beach, Florida, United States
Research Institute of the Southeast, LLC
🇺🇸West Palm Beach, Florida, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Idaho Allergy and Research
🇺🇸Eagle, Idaho, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
ASR, LLC
🇺🇸Nampa, Idaho, United States
Midwest Allergy Sinus Asthma, SC
🇺🇸Normal, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Dundee Dermatology
🇺🇸West Dundee, Illinois, United States
Forefront Dermatology, S.C.
🇺🇸Louisville, Kentucky, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Meridian Clinical Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
Forest Hills Dermatology Group
🇺🇸Kew Gardens, New York, United States
Juva Skin and Laser Center
🇺🇸New York, New York, United States
Skin Laser and Surgery Specialists of NY and NJ
🇺🇸Hackensack, New Jersey, United States
Cary Dermatology Center, PA
🇺🇸Cary, North Carolina, United States
Medication Management, LLC
🇺🇸Greensboro, North Carolina, United States
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
🇺🇸Statesville, North Carolina, United States
Winston-Salem Dermatology and Surgery Center, PLLC
🇺🇸Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Crisor, LLC
🇺🇸Medford, Oregon, United States
Oregon Health & Science University (OHSU)
🇺🇸Portland, Oregon, United States
Paddington Testing Co, Inc.
🇺🇸Philadelphia, Pennsylvania, United States
Synexus Clinical Research US. Inc.
🇺🇸Greer, South Carolina, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Arlington Research Center, Inc.
🇺🇸Arlington, Texas, United States
Center for Clinical Studies, LTD. LLP
🇺🇸Webster, Texas, United States
Virginia Dermatology and Skin Cancer Center
🇺🇸Norfolk, Virginia, United States
Velocity Urgent Care
🇺🇸Norfolk, Virginia, United States
Woden Dermatology
🇦🇺Phillip, Australian Capital Territory, Australia
Australian Clinical Research Network
🇦🇺Maroubra, New South Wales, Australia
The Skin Centre
🇦🇺Benowa, Queensland, Australia
Veracity Clinical Research Pty Ltd
🇦🇺Woolloongabba, Queensland, Australia
North Eastern Health Specialists
🇦🇺Hectorville, South Australia, Australia
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Sinclair Dermatology
🇦🇺East Melbourne, Victoria, Australia
Skin and Cancer Foundation Inc
🇦🇺Carlton, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
DCC 2/Sofia EOOD
🇧🇬Sofia, Bulgaria
Dermatology Clinic "Sofia" Ltd
🇧🇬Sofia, Bulgaria
"DCC Aleksandrovska" EOOD
🇧🇬Sofia, Bulgaria
Medical Centre Synexus Sofia EOOD-branch Stara Zagora
🇧🇬Stara Zagora, Bulgaria
"Mc Synexus Sofia" Eood
🇧🇬Sofia, Bulgaria
"DCC "Mladost-M Varna" OOD
🇧🇬Varna, Bulgaria
Pacific Dermaesthetics Inc.
🇨🇦Vancouver, British Columbia, Canada
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
DermEffects
🇨🇦London, Ontario, Canada
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
SKiN Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
AvantDerm Clinical Research
🇨🇦Toronto, Ontario, Canada
Innovaderm Research Inc.
🇨🇦Montréal, Quebec, Canada
Dr. Rachel Asiniwasis Medical Prof Corp
🇨🇦Regina, Saskatchewan, Canada
Clinica Dermacross S.A.
🇨🇱Santiago, Region Metropolitana, Chile
Centro Internacional de Estudios Clinicos - CIEC
🇨🇱Santiago, Region Metropolitana, Chile
CCR Ostrava, s.r.o.
🇨🇿Ostrava, Czechia
Dermamedica S.R.O.
🇨🇿Nachod, Czechia
CCR Czech, a.s.
🇨🇿Pardubice, Czechia
MIRES (M y F Estudios Clínicos Limitada)
🇨🇱Santiago, Región Metropolitana, Chile
BENU Lekarna
🇨🇿Pardubice, Czechia
Lekarna U sv. Ignace
🇨🇿Praha 2, Czechia
Sanatorium profesora Arenbergera
🇨🇿Praha 1, Czechia
Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie
🇨🇿Pardubice, Czechia
Synexus Czech, s.r.o.
🇨🇿Praha 2, Czechia
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Germany
Universitätsklinikum Bonn AöR
🇩🇪Bonn, Germany
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Germany
Klinikum Bielefeld Rosenhohe
🇩🇪Bielefeld, Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
🇩🇪Dresden, Germany
IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung
🇩🇪Frankfurt, Germany
Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
🇩🇪Halle, Germany
SIBAmed Studienzentrum GmbH & Co KG
🇩🇪Leipzig, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Studienzentrum Dr. med. Beate Schwarz
🇩🇪Langenau, Germany
Universitaetsklinikum Schleswig-Holstein/Campus Luebeck
🇩🇪Luebeck, Germany
Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling
🇩🇪Mahlow, Germany
Universitätsklinikum Marburg
🇩🇪Marburg, Germany
University of Muenster
🇩🇪Muenster, Germany
Medmare Bt
🇭🇺Veszprem, Hungary
SE AOK Bor-, Nemikortani es Boronkologiai Klinika
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS
🇭🇺Gyula, Hungary
Trial Pharma Kft.
🇭🇺Püspökladány, Hungary
Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
🇮🇹Roma, RM, Italy
AOU Policlinico di Modena, Struttura Complessa di Dermatologia
🇮🇹Modena, Italy
Kawashima Dermatology Clinic
🇯🇵Ichikawa, Chiba, Japan
Dermatology Shimizu Clinic
🇯🇵Kobe, Hyogo, Japan
Takagi Dermatological Clinic
🇯🇵Obihiro, Hokkaido, Japan
Noguchi Dermatology Clinic
🇯🇵Kamimashiki-gun, Kumamoto, Japan
Iidabashi Skin Clinic
🇯🇵Chiyoda-ku, Tokyo, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Shinjyuku-ku, Tokyo, Japan
Hoshikuma Dermatology・Allergy Clinic
🇯🇵Fukuoka, Japan
Jordan Valley Dermatology Center
🇺🇸West Jordan, Utah, United States
Matsuda Tomoko Dermatological Clinic
🇯🇵Fukuoka, Japan
Sanrui Hifuka
🇯🇵Saitama, Japan
Korea University Ansan Hospital
🇰🇷Ansan-si, Gyeonggi-do, Korea, Republic of
Soon Chun Hyang University Bucheon Hospital
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Chungnam National University Hospital CNUH
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei Univ. Health System
🇰🇷Seoul, Korea, Republic of
Riga 1st Hospital, Clinic for Dermatology and STD
🇱🇻Riga, Latvia
Aesthetic dermatology clinic of Prof. J. Kisis
🇱🇻Riga, Latvia
Childrens Clinical University Hospital State SLLC
🇱🇻Riga, Latvia
Health and aesthetics Ltd
🇱🇻Riga, Latvia
Arke Estudios Clinicos S.A. de C.V.
🇲🇽Cuauhtemoc, Mexico CITY, Mexico
Eukarya Pharmasite S.C.
🇲🇽Monterrey, Nuevo LEON, Mexico
Cryptex Investigación Clínica, S.A. de C.V.
🇲🇽Cuauhtemoc, Mexico CITY, Mexico
NZOZ Specjalistyczny Osrodek Dermatologiczny "DERMAL"
🇵🇱Bialystok, Poland
Centrum Medyczne SENSEMED
🇵🇱Chorzow, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
🇵🇱Gdynia, Poland
COPERNICUS-SZPITAL Oddzial Dermatologii
🇵🇱Gdansk, Poland
MCBK
🇵🇱Grodzisk Mazowiecki, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
🇵🇱Katowice, Poland
Care Clinic Centrum Medyczne
🇵🇱Katowice, Poland
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
Gabinet Dermatologiczny Beata Krecisz
🇵🇱Kielce, Poland
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc
🇵🇱Krakow, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
🇵🇱Krakow, Poland
Centrum Medyczne Promed
🇵🇱Krakow, Poland
Prywatna Praktyka Lekarska - Adam Smialowski
🇵🇱Ksawerow, Poland
Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
🇵🇱Lodz, Poland
Salve Medica Sp. z o.o. Sp. k.
🇵🇱Lodz, Poland
NZOZ "Med-Laser" Borzecki Spolka Jawna
🇵🇱Lublin, Poland
Dermedic Jacek Zdybski
🇵🇱Ostrowiec Swietokrzyski, Poland
KO-MED Centra Kliniczne Lublin II
🇵🇱Lublin, Poland
LIFT-MED Spolka Akcyjna
🇵🇱Rybnik, Poland
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.
🇵🇱Poznan, Poland
Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii
🇵🇱Rzeszow, Poland
EMED Centrum Uslug Medycznych Ewa Smialek
🇵🇱Rzeszow, Poland
Carpe Diem Centrum Medycyny Estetycznej
🇵🇱Warszawa, Poland
Medycyna Kliniczna
🇵🇱Warszawa, Poland
RCMed Oddzial Warszawa
🇵🇱Warszawa, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
🇵🇱Warszawa, Poland
MTZ Clinical Research Sp. z o.o.
🇵🇱Warszawa, Poland
Klinika Ambroziak Sp. z o.o.
🇵🇱Warszawa, Poland
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
🇵🇱Wroclaw, Poland
"REUMATIKA - Centrum Reumatologii" NZOZ
🇵🇱Warszawa, Poland
Lukasz Matusiak "4Health"
🇵🇱Wroclaw, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
SUMMIT CLINICAL RESEARCH, s.r.o.
🇸🇰Bratislava, Slovakia
Pedi-Derma s.r.o.
🇸🇰Kosice, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka Klinika
🇸🇰Nove Zamky, Slovakia
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario Fundacion Alcorcon
🇪🇸Alcorcon, Madrid, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario y Politecnico La Fe
🇪🇸Valencia, Spain
Chung Shan Medical University Hospital (CSMUH)
🇨🇳Taichung City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng-Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Medinova Research -West London Dedicated Research Centre
🇬🇧Wokingham, Berkshire, United Kingdom
Derriford Hospital
🇬🇧Plymouth, Devon, United Kingdom
Medinova Research, East London Dedicated Research Centre
🇬🇧Romford, Essex, United Kingdom
Guy's Hospital-Guy's and St Thomas NHS Foundation Trust
🇬🇧London, Greater London, United Kingdom
MeDiNova Research North London Dedicated Research Centre
🇬🇧Northwood, Middlesex, United Kingdom
Medinova Research
🇬🇧Yaxley, Peterborough, United Kingdom
Medinova Research, Warwickshire Dedicated Research Centre
🇬🇧Kenilworth, Warwickshire, United Kingdom
Medinova, Yorkshire Quality Research Site
🇬🇧Shipley, WEST Yorkshire, United Kingdom
MeDiNova Northamptonshire Dedicated Research Centre
🇬🇧Corby, United Kingdom
West Glasgow ACH, NHS Greater Glasgow and Clyde
🇬🇧Glasgow, United Kingdom
Licca Clinical Research Institute
🇩🇪Augsburg, Germany
Newton Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
TrialSpark, Inc (Russell Cohen)
🇺🇸Oceanside, New York, United States
Clinical Research Institute, Inc.
🇺🇸Minneapolis, Minnesota, United States
NorthShore University HealthSystem
🇺🇸Skokie, Illinois, United States
Portland Clinical Research dba Columbia Allergy & Asthma Clinic
🇺🇸Clackamas, Oregon, United States