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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03435081
Other study ID # 17049
Secondary ID I4V-MC-JAIW
Status Completed
Phase Phase 3
First received
Last updated
Start date February 20, 2018
Est. completion date August 16, 2021

Study information

Verified date August 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.


Recruitment information / eligibility

Status Completed
Enrollment 440
Est. completion date August 16, 2021
Est. primary completion date December 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have a diagnosis of atopic dermatitis (AD) at least 12 months before screening. - Have moderate to severe AD, including all of the following: - EASI score =16 - IGA score of =3 - =10% of BSA involvement - Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening. - Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period). - Agree to use emollients daily. Exclusion Criteria: - Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections. - A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past. - Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics. - Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma). - Have been treated with the following therapies: - monoclonal antibody for less than 5 half-lives before randomization - received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks before randomization - received any parenteral corticosteroid administered by intramuscular or intravenous injection within 6 weeks of planned randomization or are anticipated to require parenteral injection of corticosteroids during the study - have had an intra-articular corticosteroid injection within 6 weeks of planned randomization - probenecid at the time of randomization that cannot be discontinued for the duration of the study - Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg. - Have had major surgery within the past eight weeks or are planning major surgery during the study. - Have experienced any of the following within 12 weeks of screening: myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure. - Have a history of venous thromboembolic event (VTE), or are considered at high risk for VTE. - Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness. - Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis. - Have specific laboratory abnormalities. - Have received certain treatments that are contraindicated. - Pregnant or breastfeeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Baricitinib
Administered orally
Placebo
Administered orally

Locations

Country Name City State
Canada Simcoderm Medical & Surgical Dermatology Centre Barrie Ontario
Canada Institute for Skin Advancement Calgary Alberta
Canada Kirk Barber Research Calgary Alberta
Canada Stratica Medical Edmonton Alberta
Canada Kingsway Clinical Research Etobicoke Ontario
Canada Lynderm Research Inc Markham Ontario
Canada Innovaderm Research Inc Montreal Quebec
Canada Allergy Research Canada Inc. Niagara Falls Ontario
Canada SKiN Centre for Dermatology Peterborough Ontario
Canada Centre de Recherche Dermatologique de Quebec Metropolitain Quebec
Canada The Centre for Dermatology Richmond Hill Ontario
Canada York Dermatology Center Richmond Hill
Canada Medicor Research Inc Sudbury Ontario
Canada Dr. Chih-ho Hong Medical Inc. Surrey British Columbia
Canada Enverus Medical Research Surrey British Columbia
Canada K. Papp Clinical Research Inc Waterloo Ontario
Canada XLR8 Medical Research Windsor Ontario
Puerto Rico Office of Dr. Samuel Sanchez PSC Caguas
Puerto Rico Office of Dr. Alma M. Cruz Carolina
Puerto Rico Ponce School of Medicine CAIMED Center Ponce
Puerto Rico GCM Medical Group PSC San Juan
United States Great Lakes Research Group, Inc. Bay City Michigan
United States Bellaire Dermatology Bellaire Texas
United States Wallace Medical Group, Inc. Beverly Hills California
United States Bexley Dermatology Research Bexley Ohio
United States University of Alabama at Birmingham Birmingham Alabama
United States Treasure Valley Dermatology Boise Idaho
United States Brigham and Womens Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Dermatology & Laser Center of Charleston Charleston South Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Northwestern University Chicago Illinois
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Modern Research Associates PLLC Dallas Texas
United States Clinical Research Center of CT/NY Danbury Connecticut
United States University Dermatology Darien Illinois
United States California Dermatology and Clinical Research Institute Encinitas California
United States Dermatology and Skin Surgery Center Exton Pennsylvania
United States Wright State Univ School of Medicine Fairborn Ohio
United States Univ of Connecticut Farmington Connecticut
United States Hamzavi Dermatology Fort Gratiot Michigan
United States Johnson Dermatology Fort Smith Arkansas
United States Tien Q. Nguyen, MD inc. DBA First OC Dermatology Fountain Valley California
United States Center for Dermatology Clinical Research, Inc. Fremont California
United States Dawes Fretzin Clinical Research Indianapolis Indiana
United States Solutions Through Advanced Research, Inc. Jacksonville Florida
United States Clinical Partners LLC Johnston Rhode Island
United States Olympian Clinical Research Largo Florida
United States Keck School of Medicine University of Southern California Los Angeles California
United States Dermatology Specialist Louisville Kentucky
United States Dermatologic Surgery Specialists, PC Macon Georgia
United States Dermatologists of Southwest Ohio, Inc. Mason Ohio
United States Miami Dermatology & Laser Research Miami Florida
United States University of Utah MidValley Dematology Murray Utah
United States Icahn School of Medicine at Mount Sinai New York New York
United States Virginia Clinical Research Norfolk Virginia
United States Skin Specialists, P.C Omaha Nebraska
United States Riverchase Dermatology and Cosmetic Surgery Pembroke Pines Florida
United States Austin Institute for Clinical Research, Inc. Pflugerville Texas
United States The Indiana Clinical Trials Center, PC Plainfield Indiana
United States OHSU Center for Health and Healing Portland Oregon
United States Oregon Dermatology and Research Center Portland Oregon
United States Dermatology and Skin Cancer Specialists Rockville Maryland
United States Arlington Dermatology Rolling Meadows Illinois
United States University of California Davis-Dermatology Sacramento California
United States Central Dermatology PC Saint Louis Missouri
United States Texas Dermatology and Laser Specialists San Antonio Texas
United States Medical Center for Clinical Research San Diego California
United States University Clinical Trials, Inc. San Diego California
United States Advanced Medical Research Sandy Springs Georgia
United States Southern California Dermatology Santa Ana California
United States Clinical Science Institute Santa Monica California
United States Meridian Clinical Research Savannah Georgia
United States The South Bend Clinic South Bend Indiana
United States DermResearchCenter of New York, Inc Stony Brook New York
United States Acclaim Dermatology, PLLC Sugar Land Texas
United States Multicare Health System Tacoma Washington
United States ForCare Clinical Research Tampa Florida
United States University of South Florida Tampa Florida
United States Care Access Research-Walnut Creek Walnut Creek California
United States GWU/Medical Faculty Associates Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib) 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 to 72 (severe). The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Week 16
Secondary Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a = 2 Point Improvement 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. Week 16
Secondary Percentage of Participants Achieving EASI75 (1 mg Baricitinib) 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 to 72 (severe). The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Week 16
Secondary Percentage of Participants Achieving EASI90 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 to 72 (severe). The EASI90 is defined as a = 90% improvement from baseline in the EASI score. Week 16
Secondary Percent Change From Baseline in EASI Score 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 to 72 (severe).
Least Squares (LS) Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a = 75% improvement from baseline in the SCORAD score. Week 16
Secondary Percentage of Participants Achieving a 4-Point Improvement on the Itch Numeric Rating Scale (NRS) The Itch NRS is a patient-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 participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. 16 Weeks
Secondary Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually.
LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline in Skin Pain NRS Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.
LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of of Participants Achieving EASI50 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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and 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 to 72 (severe). The EASI50 is defined as a = 50% improvement from baseline in EASI score. Week 16
Secondary Percentage of Participants Achieving IGA of 0 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. Week 16
Secondary Change From Baseline in SCORAD The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit and treatment-by-visit interaction as fixed categorial effects and baseline and baseline-by-visit interaction as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of Participants Achieving SCORAD90 The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a = 90% improvement from baseline in the SCORAD score. Week 16
Secondary Change From Baseline in Body Surface Area (BSA) Affected Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs.
LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment Percentage of participants developing skin infections requiring antibiotic treatment. Week 16
Secondary Percent Change From Baseline in Itch NRS The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA),and treatment-by-visit-interaction as fixed categorical effects and baseline, and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM) The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.
LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe."
LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline on the Hospital Anxiety Depression Scale (HADS) The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline on the Dermatology Life Quality Index (DLQI) The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered or "not relevant" responses scored as "0." Scores range from 0 to 30 ("no impact on participant's life" to "extremely large effect on participant's life"), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.
LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA),visit, and treatment-by-visit-interaction as fixed categorical and baseline, and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment.
LS Mean were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States (US) and United Kingdom (UK) Algorithm The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the UK algorithm, with scores ranging from -0.594 to 1, and the US algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state.
LS Means were calculated using a MMRM model with treatment, baseline disease activity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS) EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranges from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.
LS Means were calculated using a MMRM model with treatment, baseline disease activity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a = 2 Point Improvement 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. Week 4
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