A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI)
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- STATUS
- Recruiting
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- End date
- Oct 15, 2030
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- participants needed
- 1340
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- sponsor
- Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
Description
This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.
Details
| Condition | Crohn's Disease |
|---|---|
| Treatment | Placebo, Guselkumab, ustekinumab, Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Guselkumab Dose 4, Guselkumab Dose 5 |
| Clinical Study Identifier | NCT03466411 |
| Sponsor | Janssen Research & Development, LLC |
| Last Modified on | 27 October 2022 |
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