CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 837 enrolled
Drug / intervention
Guselkumab 100 mg +3 moredrug
Likely dose
Guselkumab 100 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/NCT02207231
NCT02207231Phase 3Completed
CompareCT.gov

Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis

Janssen Research & Development, LLC·interventional·Posted Aug 4, 2014·Updated Jul 23, 2021

In Brief

A Phase 3 clinical trial evaluating Guselkumab 100 mg, Placebo for guselkumab, and 2 other interventions for Psoriasis. Completed, enrolled 837 participants across 97 sites in 10 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 4, 2014
Enrollment StartNov 26, 2014
Primary CompletionSep 29, 2015
Study CompletionJun 17, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.9 years ago

Interventions

Guselkumab 100 mgdrug

100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).

Placebo for guselkumabdrug

Subcutaneous injections to maintain the blind.

Adalimumabdrug

80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.

Placebo for adalimumabdrug

Subcutaneous injections to maintain the blind.