Trials / Completed
CompletedNCT05013905
A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRA023 IV | PRA023 administered at timepoints as directed by the protocol |
| DEVICE | Companion diagnostic (CDx) | CDx+ or CDx- |
Timeline
- Start date
- 2021-07-28
- Primary completion
- 2022-09-23
- Completion
- 2025-05-27
- First posted
- 2021-08-19
- Last updated
- 2025-07-04
- Results posted
- 2023-11-01
Locations
37 sites across 8 countries: United States, Australia, Belgium, Canada, Czechia, France, Georgia, Poland
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05013905. Inclusion in this directory is not an endorsement.