Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion

Description

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 116-week outpatient study, includes a treatment period of approximately 104-weeks and up to 11 planned study visits.

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

Keywords

Atopic Dermatitis eczema atopic eczema Dermatitis Dermatitis, Atopic Baricitinib

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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.

Locations

  • University of California Davis-Dermatology
    Sacramento California 95816 United States
  • Wallace Medical Group, Inc.
    Beverly Hills California 90211 United States
  • Clinical Science Institute
    Santa Monica California 90404 United States
  • Tien Q. Nguyen, MD inc. DBA First OC Dermatology
    Fountain Valley California 92708 United States
  • University Clinical Trials, Inc.
    San Diego California 92123 United States
  • Southern California Dermatology
    Santa Ana California 92701 United States
  • Medical Center for Clinical Research
    San Diego California 92108 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT03559270
Phase
Phase 3
Study Type
Interventional
Last Updated