CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 961 enrolled
Drug / intervention
Placebo IV +3 moredrug
Likely dose
Not stated in 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/NCT02407236
NCT02407236Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Janssen Research & Development, LLC·interventional·Posted Apr 2, 2015·Updated Apr 29, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo IV, Placebo SC, and 2 other interventions for Colitis, Ulcerative and Inflammatory Bowel Diseases. Completed, enrolled 961 participants across 247 sites in 23 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative, Inflammatory Bowel Diseases
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Japan, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2, 2015
Enrollment StartJul 10, 2015
Primary CompletionAug 10, 2018
Study CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.3 years ago

Interventions

Placebo IVdrug

Placebo will be administered as intravenous infusion.

Placebo SCdrug

Placebo will be administered Subcutaneously.

Ustekinumab IVdrug

Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.

Ustekinumab SCdrug

Ustekinumab will be administered as subcutaneously.