CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 167 enrolled
Drug / intervention
Upadacitinib +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Confirmed atopic dermatitis diagnosis (Hanifin and Rajka criteria) with symptom onset ≥1 year before baseline
  • ✓Moderate-to-severe disease: EASI ≥16, body surface area ≥10%, and Investigator's Global Assessment ≥3
  • ✓Documented inadequate response to topical corticosteroids or calcineurin inhibitors within 1 year, OR topical treatments medically inadvisable
  • ✓Twice-daily use of bland, additive-free emollient for ≥7 days prior to baseline
Key exclusion· 4
  • ✕Prior exposure to any JAK inhibitor (including tofacitinib, baricitinib, ruxolitinib, filgotinib)
  • ✕Topical corticosteroids, calcineurin inhibitors, or specialty moisturizers within 10 days before baseline
  • ✕Prior dupilumab or systemic therapies for atopic dermatitis (corticosteroids, methotrexate, cyclosporine, azathioprine, PDE4 inhibitors, mycophenolate mofetil) within 4 weeks
  • ✕Exposure to any investigational systemic treatment within 30 days or 5 half-lives (whichever longer) or enrollment in another clinical study

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

Search/NCT02925117
NCT02925117Phase 2Completed
CompareCT.gov

A Phase 2b Multicenter, Randomized, Placebo-Controlled, Double-Blind Dose-Ranging Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects With Moderate to Severe Atopic Dermatitis

AbbVie·interventional·Posted Oct 5, 2016·Updated Jul 16, 2020

In Brief

A Phase 2 clinical trial evaluating Upadacitinib and Placebo for Atopic Dermatitis. Completed, enrolled 167 participants across 34 sites in 8 countries.

Detailed Summary

The objective of this study was to evaluate the safety and efficacy of multiple doses of upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis (AD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesAustralia, Canada, Finland, Germany, Japan, Netherlands, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 5, 2016
Enrollment StartOct 25, 2016
Primary CompletionAug 10, 2017
Study CompletionJan 31, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.7 years ago

Interventions

Upadacitinibdrug

Tablet for oral use

Placebodrug

Tablet