Status:
COMPLETED
A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Incyte Corporation
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies...
Eligibility Criteria
Inclusion
- Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions:
Exclusion
- Had investigational product permanently discontinued at any time during a previous Baricitinib study.
- 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
- OR
- Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:
- Inclusion Criteria:
- Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
- 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 during a washout period).
- Agree to use emollients daily.
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2023
Estimated Enrollment :
1645 Patients enrolled
Trial Details
Trial ID
NCT03334435
Start Date
March 28 2018
End Date
July 12 2023
Last Update
September 3 2024
Active Locations (185)
Enter a location and click search to find clinical trials sorted by distance.
1
CEDIC-Centro de Investigaciones Clinicas
Caba, Buenos Aires, Argentina, C1425DES
2
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina, C1027AAP
3
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, Argentina, C1055AA0
4
Fundacion CIDEA
Ciudad Autonoma Buenos Aires, Argentina, C1121ABE