CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 463 enrolled
Drug / intervention
Baricitinib +2 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.

Search/NCT03428100
NCT03428100Phase 3Completed

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine

Eli Lilly and Company·interventional·Posted Feb 9, 2018·Updated May 14, 2024

In Brief

A Phase 3 clinical trial evaluating Baricitinib, Placebo, and 1 other intervention for Atopic Dermatitis. Completed, enrolled 463 participants across 103 sites in 14 countries.

Detailed Summary

The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Brazil, Finland, France, Germany, Italy, Japan, Netherlands, Poland, Russia, Spain, Switzerland, United Kingdom
CollaboratorsIncyte Corporation

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 9, 2018
Enrollment StartMay 15, 2018
Primary CompletionNov 25, 2019
Study CompletionApr 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.4 years ago

Interventions

Baricitinibdrug

Administered orally.

Placebodrug

Administered orally.

Topical corticosteroiddrug

Administered as standard-of-care.