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

NCT ID: NCT03559270

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 374 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-27
• Study Completion Date: 2022-06-13

Brief 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).

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placebo/Baricitinib 2-milligram (mg)

Open-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Baricitinib 1-mg/Baricitinib 2-mg

Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Baricitinib 2-mg/Baricitinib 2-mg

Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Baricitinib 2-mg Open-Label Addendum

Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Interventions

Baricitinib

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3009104

Eligibility 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

• 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:

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Johnson Dermatology

Fort Smith, Arkansas, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

First OC Dermatology

Fountain Valley, California, United States

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

Keck School of Medicine University of Southern California

Los Angeles, California, United States

Wallace Medical Group, Inc.

Los Angeles, California, United States

University of California Davis-Dermatology

Sacramento, California, United States

Medical Center For Clinical Research

San Diego, California, United States

University Clinical Trials, Inc.

San Diego, California, United States

Southern California Dermatology, Inc.

Santa Ana, California, United States

Clinical Science Institute

Santa Monica, California, United States

Care Access Research-Walnut Creek

Walnut Creek, California, United States

GWU/Medical Faculty Associates

Washington D.C., District of Columbia, United States

Solutions Through Advanced Research, Inc.

Jacksonville, Florida, United States

Olympian Clinical Research

Largo, Florida, United States

Miami Dermatology and Laser Research

Miami, Florida, United States

Riverchase Dermatology and Cosmetic Surgery

Pembroke Pines, Florida, United States

University of South Florida

Tampa, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Dermatologic Surgery Specialists, PC

Macon, Georgia, United States

Advanced Medical Research

Sandy Springs, Georgia, United States

Advanced Clinical Research LLC

Meridian, Idaho, United States

Northwestern University

Chicago, Illinois, United States

University Dermatology

Darien, Illinois, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

The South Bend Clinic Center for Research

South Bend, Indiana, United States

Forefront Research

Louisville, Kentucky, United States

Dermatology and Skin Cancer Specialists

Rockville, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Central Dermatology PC

St Louis, Missouri, United States

Skin Specialists, P.C

Omaha, Nebraska, United States

Icahn Sch of Med at Mt. Sinai

New York, New York, United States

DermResearchCenter of New York, Inc

Stony Brook, New York, United States

Bexley Dermatology Research

Bexley, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Wright State Univ School of Medicine

Fairborn, Ohio, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

OHSU Center for Health and Healing

Portland, Oregon, United States

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Bellaire Dermatology

Bellaire, Texas, United States

Modern Research Associates

Dallas, Texas, United States

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

University of Utah MidValley Dematology

Murray, Utah, United States

MultiCare Good Samaritan Hospital

Tacoma, Washington, United States

Kirk Barber Research

Calgary, Alberta, Canada

Beacon Dermatology

Calgary, Alberta, Canada

Alberta DermaSurgery Centre

Edmonton, Alberta, Canada

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

Simcoderm Medical & Surgical Dermatology Centre

Barrie, Ontario, Canada

Kingsway Clinical Research

Etobicoke, Ontario, Canada

Medicor Research Inc

Greater Sudbury, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

Allergy Research Canada Inc.

Niagara Falls, Ontario, Canada

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

York Dermatology Center

Richmond Hill, Ontario, Canada

K. Papp Clinical Research

Waterloo, Ontario, Canada

XLR8 Medical Research

Windsor, Ontario, Canada

Innovaderm Research Inc

Montreal, Quebec, Canada

Centre de Recherche Dermatologique de Quebec Metropolitain

Québec, Quebec, Canada

Dr. Samuel Sanchez PSC

Caguas, PR, Puerto Rico

Office of Dr. Alma M. Cruz

Carolina, PR, Puerto Rico

Ponce School of Medicine CAIMED Center

Ponce, PR, Puerto Rico

GCM Medical Group, PSC - Hato Rey Site

San Juan, PR, Puerto Rico

Countries

United States; Canada; Puerto Rico

References

Wollenberg A, Kircik L, Simpson E, Brinker D, Katoh N, Rueda MJ, Issa M, Yang F, Feely M, Alexis A. Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials. Dermatitis. 2023 Jul-Aug;34(4):308-314. doi: 10.1089/derm.2022.0027. Epub 2023 Feb 6.

Reference Type: DERIVED

PMID: 36749121 (View on PubMed)

King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

Reference Type: DERIVED

PMID: 33826132 (View on PubMed)

Provided Documents

Document Type: Study Protocol: JAIX 05 Protocol (c).pdf

View Document

Document Type: Study Protocol: JAIX 05 Protocol Addenda (2)

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/11hI0LRhfAAIAAa2qKq0ok

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

Other Identifiers

I4V-MC-JAIX

Identifier Type: OTHER

Identifier Source: secondary_id

17064

Identifier Type: -

Identifier Source: org_study_id