A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis (BREEZE-AD3)
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
Actual Study Start Date: March 28, 2018
Estimated Primary Completion Date: July 30, 2021
Estimated Study Completion Date: August 27, 2021
Arms:
- Experimental: Baricitinib High Dose Nonresponders
- Experimental: Baricitinib High Dose Nonresponders Rescued
- Experimental: Baricitinib Mid Dose Nonresponders Rescued
- Experimental: Baricitinib High Dose Responders
- Experimental: Baricitinib Mid Dose Responders
- Experimental: Baricitinib Low Dose Responders
- Placebo Comparator: Placebo Responders
- Experimental: Baricitinib Open Label Extension
| Category | Value |
|---|---|
| Date last updated at source | 2019-03-06 |
| Study type(s) | Interventional |
| Expected enrolment | 1500 |
| Study start date | 2018-03-28 |
| Estimated primary completion date | 2021-07-30 |