CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 912 enrolled / 912 target
Drug / intervention
Placebo for Upadacitinib +1 moredrug
Likely dose
15 mgfrom 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/NCT03607422
NCT03607422Phase 3CompletedMonitor (9.6/mo)Completion was 63mo ago
CompareCT.gov

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

AbbVie·interventional·Posted Jul 31, 2018·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating Placebo for Upadacitinib and Upadacitinib for Atopic Dermatitis. Completed, enrolled 912 participants across 196 sites in 23 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, New Zealand, Portugal, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 31, 2018
Enrollment StartJul 27, 2018
Primary CompletionMar 11, 2021
Study CompletionNov 11, 2025
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.9 years ago

Arms & Interventions

Placebo / Upadacitinibplacebo_comparator

Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16, participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260.

Drug: Placebo for UpadacitinibDrug: Upadacitinib
Upadacitinib 15 mg QDexperimental

Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.

Drug: Upadacitinib
Upadacitinib 30 mg QDexperimental

Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.

Drug: Upadacitinib

Interventions

Placebo for Upadacitinibdrug

Tablets taken orally once a day

Upadacitinibdrug

Tablets taken orally once a day