Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
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 204-week outpatient study, includes a treatment period of approximately 200-weeks and up to 17 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, Atopic Dermatitis 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
  • Care Access Research-Walnut Creek
    Walnut Creek California 94598 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis Sign up for this study
ID
NCT03559270
Phase
Phase 3
Study Type
Interventional
Last Updated