CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 307 enrolled
Drug / intervention
Ruxolitinib 0.15% Cream QD +5 moredrug
Likely dose
Ruxolitinib 1.5% cream once or twice dailyAI-extracted
Key inclusion· 5
  • ✓Diagnosed with atopic dermatitis per Hanifin and Rajka criteria
  • ✓At least 2 years history of atopic dermatitis
  • ✓Investigator's Global Assessment (IGA) score 2-3 at screening and baseline
  • ✓Body surface area (BSA) of AD involvement 3-20%, excluding face and intertriginous areas
Key exclusion· 7
  • ✕Evidence of active acute or chronic infections
  • ✕Topical treatments for AD (other than bland emollients) within 2 weeks of baseline
  • ✕Systemic immunosuppressive or immunomodulating drugs within 4 weeks or 5 half-lives of baseline (whichever is longer)
  • ✕Other dermatologic disease besides AD whose presence or treatments could complicate disease assessment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03011892
NCT03011892Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream-Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

Incyte Corporation·interventional·Posted Jan 5, 2017·Updated Apr 9, 2021

In Brief

A Phase 2 clinical trial evaluating Ruxolitinib 0.15% Cream QD, Ruxolitinib 0.5% Cream QD, and 4 other interventions for Atopic Dermatitis. Completed, enrolled 307 participants across 52 sites in 2 countries.

Detailed Summary

The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 5, 2017
Enrollment StartJan 9, 2017
Primary CompletionJan 10, 2018
Study CompletionMar 12, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.5 years ago

Interventions

Ruxolitinib 0.15% Cream QDdrug

Ruxolitinib 0.15% cream QD

Ruxolitinib 0.5% Cream QDdrug

Ruxolitinib 0.5% cream QD

Ruxolitinib 1.5% Cream QDdrug

Ruxolitinib 1.5% cream QD

Ruxolitinib 1.5% Cream BIDdrug

Ruxolitinib 1.5% cream BID

Triamcinolone 0.1% Cream BIDdrug

Triamcinolone 0.1% cream BID

Vehicle Cream BIDdrug

Vehicle cream BID