Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 62 for:    Baricitinib

A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis (BREEZE-AD6)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03559270
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2018
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

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), who have completed participation in study BREEZE-AD5/Study JAIW (NCT03435081). This 204-week outpatient study, includes a treatment period of approximately 200-weeks and up to 17 planned study visits.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Baricitinib Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : November 25, 2021
Estimated Study Completion Date : December 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Baricitinib
Baricitinib administered orally.
Drug: Baricitinib
Administered orally
Other Name: LY3009104




Primary Outcome Measures :
  1. Proportion of Participants Achieving Eczema Area and Severity Index (EASI75) [ Time Frame: Week 16 ]
    Proportion of participants achieving EASI75


Secondary Outcome Measures :
  1. Proportion of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 [ Time Frame: Week 16 ]
    Proportion of participants achieving IGA of 0 or 1

  2. Proportion of Participants Achieving a Body Surface Area of ≤3% [ Time Frame: Week 16 ]
    Proportion of participants achieving a body surface area of ≤3%

  3. Proportion of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS) [ Time Frame: Week 16 ]
    Proportion of participants achieving a ≥4-point improvement in itch NRS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been discontinued from study JAIW, and completed at least 16 weeks on treatment.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559270


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arkansas
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
United States, California
Wallace Medical Group, Inc.
Beverly Hills, California, United States, 90211
California Dermatology and Clinical Research Institute
Encinitas, California, United States, 92024
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, United States, 92708
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Keck School of Medicine University of Southern California
Los Angeles, California, United States, 90033
University of California Davis-Dermatology
Sacramento, California, United States, 95816
Medical Center for Clinical Research
San Diego, California, United States, 92108
University Clinical Trials, Inc.
San Diego, California, United States, 92123
Southern California Dermatology
Santa Ana, California, United States, 92701
Clinical Science Institute
Santa Monica, California, United States, 90404
Care Access Research-Walnut Creek
Walnut Creek, California, United States, 94598
United States, District of Columbia
GWU/Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Florida
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States, 32256
Olympian Clinical Research
Largo, Florida, United States, 33770
Miami Dermatology & Laser Research
Miami, Florida, United States, 33173
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, United States, 33028
University of South Florida
Tampa, Florida, United States, 33612
ForCare Clinical Research
Tampa, Florida, United States, 33613
United States, Georgia
Dermatologic Surgery Specialists, PC
Macon, Georgia, United States, 31217
Advanced Medical Research
Sandy Springs, Georgia, United States, 30328
United States, Idaho
Dermatology Center of Canyon County
Nampa, Idaho, United States, 83651
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University Dermatology
Darien, Illinois, United States, 60561
Arlington Dermatology
Rolling Meadows, Illinois, United States, 60008
United States, Indiana
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States, 46250
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
The South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Kentucky
Dermatology Specialist
Louisville, Kentucky, United States, 40241
United States, Maryland
Dermatology and Skin Cancer Specialists
Rockville, Maryland, United States, 20850
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Great Lakes Research Group, Inc.
Bay City, Michigan, United States, 48706
United States, Missouri
Central Dermatology PC
Saint Louis, Missouri, United States, 63117
United States, Nebraska
Skin Specialists, P.C
Omaha, Nebraska, United States, 68144
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10003
DermResearchCenter of New York, Inc
Stony Brook, New York, United States, 11790
United States, Ohio
Bexley Dermatology Research
Bexley, Ohio, United States, 43209
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Wright State Univ School of Medicine
Fairborn, Ohio, United States, 45324
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
OHSU Center for Health and Healing
Portland, Oregon, United States, 97239
United States, Pennsylvania
Dermatology and Skin Surgery Center
Exton, Pennsylvania, United States, 19341
United States, Rhode Island
Clinical Partners LLC
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States, 29407
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Bellaire Dermatology
Bellaire, Texas, United States, 77401
Modern Research Associates PLLC
Dallas, Texas, United States, 75231
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States, 78660
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Acclaim Dermatology, PLLC
Sugar Land, Texas, United States, 77497
United States, Utah
University of Utah MidValley Dematology
Murray, Utah, United States, 84107
United States, Washington
Multicare Health System
Tacoma, Washington, United States, 98405
Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2G 1B1
Institute for Skin Advancement
Calgary, Alberta, Canada, T3A 2N1
Stratica Medical
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada, V3R 6A7
Enverus Medical Research
Surrey, British Columbia, Canada, V3V 0C6
Canada, Ontario
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, Canada, L4M 7G1
Kingsway Clinical Research
Etobicoke, Ontario, Canada, M8X 1Y9
Lynderm Research Inc
Markham, Ontario, Canada, L3P1X2
Allergy Research Canada Inc.
Niagara Falls, Ontario, Canada, L2H 1H5
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
Medicor Research Inc
Sudbury, Ontario, Canada, P3A 1W8
K. Papp Clinical Research Inc
Waterloo, Ontario, Canada, N2J 1C4
XLR8 Medical Research
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
Innovaderm Research Inc
Montreal, Quebec, Canada, H2K4L5
Canada
Centre de Recherche Dermatologique de Quebec Metropolitain
Quebec, Canada, G1V 4X7
York Dermatology Center
Richmond Hill, Canada, L4C 9M7
Puerto Rico
Office of Dr. Samuel Sanchez PSC
Caguas, Puerto Rico, 00727
Office of Dr. Alma M. Cruz
Carolina, Puerto Rico, 00985
Ponce School of Medicine CAIMED Center
Ponce, Puerto Rico, 00716
GCM Medical Group PSC
San Juan, Puerto Rico, 00917
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
Layout table for investigator information
Study Director: 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) Eli Lilly and Company

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03559270     History of Changes
Other Study ID Numbers: 17064
I4V-MC-JAIX ( Other Identifier: Eli Lilly and Company )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 15, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
eczema
atopic eczema
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases