CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 1,064 enrolled / 1,064 target
Drug / intervention
Placebo +1 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/NCT04033445
NCT04033445Phase 2ActiveUpdate Overdue (13.1/mo)Completion was 33mo ago
CompareCT.gov

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Janssen Research & Development, LLC·interventional·Posted Jul 26, 2019·Updated Jun 5, 2026

In Brief

A Phase 2 clinical trial evaluating Placebo and Guselkumab for Ulcerative Colitis. Active but no longer recruiting, targeting 1,064 participants across 392 sites in 34 countries.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Jordan, Latvia, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2Active
20202021202220232024202520262027
First PostedJul 26, 2019
Enrollment StartSep 26, 2019
Primary CompletionSep 19, 2023
Study CompletionSep 29, 2027
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.9 years ago

Arms & Interventions

Induction Study 1: Guselkumab Dose 1experimental

Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Drug: Guselkumab
Induction Study 1: Guselkumab Dose 2experimental

Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Drug: Guselkumab
Induction Study 1: Placebo IVplacebo_comparator

Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Drug: Placebo
Induction Study 2: Guselkumab IVexperimental

Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Drug: Guselkumab
Induction Study 2: Placebo IVplacebo_comparator

Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Drug: Placebo
Maintenance Study: Maintenance Dose Regimen 1experimental

Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).

Drug: Guselkumab
Maintenance Study: Maintenance Dose Regimen 2experimental

Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).

Drug: Guselkumab
Maintenance Study: Placebo SCplacebo_comparator

Participants will receive matching placebo SC q4w.

Drug: Placebo

Interventions

Placebodrug

Participants will receive matching placebo IV or SC.

Guselkumabdrug

Participants will receive guselkumab IV or SC.