CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
Ustekinumab +2 moredrug
Likely dose
Ustekinumab 45 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/NCT01945086
NCT01945086Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Ustekinumab in Adult Japanese Subjects With Severe Atopic Dermatitis

Janssen Pharmaceutical K.K.·interventional·Posted Sep 18, 2013·Updated Mar 9, 2016

In Brief

A Phase 2 clinical trial evaluating Ustekinumab, Placebo, and 1 other intervention for Dermatitis, Atopic. Completed, enrolled 79 participants across 13 sites.

Detailed Summary

The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab compared with placebo (inactive medication) in adult Japanese participants with severe atopic dermatitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Atopic
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 18, 2013
Enrollment StartSep 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.8 years ago

Interventions

Ustekinumabdrug

Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4.

Placebodrug

Participants will receive SC injections of placebo at Week 0 and Week 4.

Concomitant topical medications for atopic dermatitisother

Concomitant topical medications (as defined in the protocol) can be used from 4 weeks prior to randomization and throughout the study. However, the dosage cannot be increased and new medications cannot be added until after Week 12.