At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 784 enrolled
Drug / intervention
Baricitinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
In Brief
A Phase 3 clinical trial evaluating Baricitinib and Placebo for Alopecia Areata. Completed, enrolled 784 participants across 75 sites in 5 countries.
Detailed Summary
This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlopecia Areata
CountriesJapan, Mexico, Puerto Rico, South Korea, United States
CollaboratorsIncyte Corporation
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartSep 2018
Primary CompletionFeb 2021
Study CompletionJan 2025
TodayJul 2026
First PostedJun 27, 2018
Enrollment StartSep 24, 2018
Primary CompletionFeb 2, 2021
Study CompletionJan 29, 2025
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.0 years ago
Interventions
Baricitinibdrug
Administered orally.
Placebodrug
Administered orally.