Clinical trial NCT03559270: A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: eczema
atopic eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2018-06-18
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1
timeFrame: Week 16
measure: Percentage of Participants Achieving a Body Surface Area (BSA) of ≤3%
timeFrame: Week 16
measure: Percentage of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS)
timeFrame: Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine University of Southern California
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group, Inc.
state: California
city: Sacramento
country: United States
facility: University of California Davis-Dermatology
state: California
city: San Diego
country: United States
facility: Medical Center For Clinical Research
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Walnut Creek
country: United States
facility: Care Access Research-Walnut Creek
state: California
city: Washington
country: United States
facility: GWU/Medical Faculty Associates
state: District of Columbia
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Largo
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Pembroke Pines
country: United States
facility: Riverchase Dermatology and Cosmetic Surgery
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, PC
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research LLC
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Darien
country: United States
facility: University Dermatology
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic Center for Research
state: Indiana
city: Louisville
country: United States
facility: Forefront Research
state: Kentucky
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, P.C
state: Nebraska
city: New York
country: United States
facility: Icahn Sch of Med at Mt. Sinai
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc
state: New York
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Fairborn
country: United States
facility: Wright State Univ School of Medicine
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: OHSU Center for Health and Healing
state: Oregon
city: Exton
country: United States
facility: The Pennsylvania Centre for Dermatology, LLC
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Bellaire
country: United States
facility: Bellaire Dermatology
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Murray
country: United States
facility: University of Utah MidValley Dematology
state: Utah
city: Tacoma
country: United States
facility: MultiCare Good Samaritan Hospital
state: Washington
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Calgary
country: Canada
facility: Beacon Dermatology
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Barrie
country: Canada
facility: Simcoderm Medical & Surgical Dermatology Centre
state: Ontario
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Niagara Falls
country: Canada
facility: Allergy Research Canada Inc.
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Center
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique de Quebec Metropolitain
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC
city: Carolina
country: Puerto Rico
facility: Office of Dr. Alma M. Cruz
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine CAIMED Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.