CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 418 enrolled / 418 target
Drug / intervention
Guselkumab Dose 1 +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/NCT05528510
NCT05528510Phase 3ActiveUpdate Overdue (9.2/mo)Completion was 26mo ago
CompareCT.gov

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Janssen Research & Development, LLC·interventional·Posted Sep 6, 2022·Updated Jun 8, 2026

In Brief

A Phase 3 clinical trial evaluating Guselkumab Dose 1, Guselkumab Dose 2, and 2 other interventions for Colitis, Ulcerative. Active but no longer recruiting, targeting 418 participants across 236 sites in 25 countries.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, India, Israel, Japan, Jordan, Malaysia, Mexico, New Zealand, Poland, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3Active
202320242025202620272028
First PostedSep 6, 2022
Enrollment StartSep 13, 2022
Primary CompletionApr 2, 2024
Study CompletionOct 6, 2028
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.8 years ago

Arms & Interventions

Group 1: Guselkumabexperimental

Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.

Drug: Guselkumab Dose 1Drug: Guselkumab Dose 2
Group 2: Guselkumabexperimental

Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.

Drug: Guselkumab Dose 1Drug: Guselkumab Dose 3
Group 3: Placeboplacebo_comparator

Participants will receive matching placebo SC injection.

Other: Placebo

Interventions

Guselkumab Dose 1drug

Guselkumab (Dose 1) will be administered as SC injection.

Guselkumab Dose 2drug

Guselkumab (Dose 2) will be administered as SC injection.

Guselkumab Dose 3drug

Guselkumab (Dose 3) will be administered as SC injection.

Placeboother

Placebo will be administered as SC injection.