A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— BREEZE-AD6  

Official title:

A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03559270
• Other study ID #: 17064
• Secondary ID: I4V-MC-JAIX
• Status: Terminated
• Phase: Phase 3
• Start date: June 27, 2018
• Est. completion date: June 13, 2022

Study information

• Verified date: October 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis (AD).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 374
• Est. completion date: June 13, 2022
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Have participated in Study JAIW (NCT03435081), and meet specific completion requirements for that study, and do not meet any of the following Exclusions:

• Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered.

• Have a known hypersensitivity to baricitinib or any component of this investigational product.

• Had investigational product permanently discontinued at any time during a previous baricitinib study, except for participants who had investigational product discontinued during originating study because of rescue with an oral systemic AD therapy (e.g., corticosteroid, cyclosporine, methotrexate).

• Had temporary investigational product interruption continue at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study.

• Pregnant or breastfeeding

OR

• Have not participated in a Study JAIW (NCT03435081) and satisfy the following criteria:

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%- 50% 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)

• 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 episodes 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, 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Baricitinib
Administered orally

Locations

Country	Name	City	State
Canada	Simcoderm Medical & Surgical Dermatology Centre	Barrie	Ontario
Canada	Beacon Dermatology	Calgary	Alberta
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Alberta DermaSurgery Centre	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	Ontario
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	Waterloo	Ontario
Canada	XLR8 Medical Research	Windsor	Ontario
Puerto Rico	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 - Hato Rey Site	San Juan
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Bellaire Dermatology	Bellaire	Texas
United States	Bexley Dermatology Research	Bexley	Ohio
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Clinical Research Center of the Carolinas	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	Dallas	Texas
United States	University Dermatology	Darien	Illinois
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	The Pennsylvania Centre for Dermatology, LLC	Exton	Pennsylvania
United States	Wright State Univ School of Medicine	Fairborn	Ohio
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	First OC Dermatology	Fountain Valley	California
United States	Center For Dermatology Clinical Research, Inc.	Fremont	California
United States	Dawes Fretzin Clinical Research Group, LLC	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	Wallace Medical Group, Inc.	Los Angeles	California
United States	Forefront Research	Louisville	Kentucky
United States	Dermatologic Surgery Specialists, PC	Macon	Georgia
United States	Advanced Clinical Research LLC	Meridian	Idaho
United States	Miami Dermatology and Laser Research	Miami	Florida
United States	University of Utah MidValley Dematology	Murray	Utah
United States	Icahn Sch of Med at Mt. Sinai	New York	New York
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	Pflugerville	Texas
United States	The Indiana Clinical Trials Center	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, Inc.	Santa Ana	California
United States	Clinical Science Institute	Santa Monica	California
United States	The South Bend Clinic Center for Research	South Bend	Indiana
United States	DermResearchCenter of New York, Inc	Stony Brook	New York
United States	MultiCare Good Samaritan Hospital	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)	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.; 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 EASI75.	Week 16
Secondary	Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1	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.	Week 16
Secondary	Percentage of Participants Achieving a Body Surface Area (BSA) of =3%	The BSA affected by AD will be assessed for 4 separate body regions: 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. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.	Week 16
Secondary	Percentage of Participants Achieving a =4-Point Improvement in Itch Numeric Rating Scale (NRS)	The 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 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.	Week 16

External Links

•   A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis