CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 872 enrolled
Drug / intervention
Ustekinumab +3 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/NCT02203032
NCT02203032Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

Janssen Research & Development, LLC·interventional·Posted Jul 29, 2014·Updated Sep 12, 2017

In Brief

A Phase 3 clinical trial evaluating Ustekinumab, Guselkumab, and 2 other interventions for Psoriasis. Completed, enrolled 872 participants across 85 sites in 10 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesAustralia, Canada, Germany, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 29, 2014
Enrollment StartOct 7, 2014
Primary CompletionDec 25, 2015
Study CompletionMay 24, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.9 years ago

Interventions

Ustekinumabdrug

45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.

Guselkumabdrug

100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.

Placebo for ustekinumabdrug

Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.

Placebo for guselkumabdrug

Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.