At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 214 enrolled
Drug / intervention
Guselkumab Dose 1 +4 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.
A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating Guselkumab Dose 1, Guselkumab Dose 2, and 3 other interventions for Colitis, Ulcerative. Completed, enrolled 214 participants across 82 sites in 9 countries.
Detailed Summary
The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesArgentina, Australia, Brazil, Germany, Mexico, Poland, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartNov 2018
Primary CompletionDec 2020
Study CompletionNov 2021
TodayJul 2026
First PostedSep 7, 2018
Enrollment StartNov 20, 2018
Primary CompletionDec 1, 2020
Study CompletionNov 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.8 years ago
Interventions
Guselkumab Dose 1drug
Guselkumab Dose 1 will be administered as IV infusion.
Guselkumab Dose 2drug
Guselkumab Dose 2 will be administered as SC injection.
Golimumab Dose 1drug
Golimumab Dose 1 will be administered as SC injection.
Golimumab Dose 2drug
Golimumab Dose 2 will be administered as SC injection.
Placebodrug
Placebo will be administered.