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NCT05013905 · ClinicalTrials.gov registry record · Phase 2
A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
A Phase 2 study of Crohn Disease, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 20
- Study locations
NCT05013905 is a Phase 2 study of Crohn Disease that has completed, run by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 55 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT05013905, a Phase 2 study of Crohn Disease, has completed, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG PRA023 IV
- DEVICE Companion diagnostic (CDx)
Study Locations (20)
Texas
- Prometheus Biosciences Selected Site - Garland
- Prometheus Biosciences Selected Site - Lubbock
- Prometheus Biosciences Selected Site - Lubbock
- Prometheus Biosciences Selected Site - San Antonio
- Prometheus Biosciences Selected Site - Southlake
- Prometheus Biosciences Selected Site - Tyler
California
- Prometheus Biosciences Selected Site - Los Angeles
- Prometheus Biosciences Selected Site - Los Angeles
Michigan
- Prometheus Biosciences Selected Site - Chesterfield
- Prometheus Biosciences Selected Site - Ypsilanti
Washington
- Prometheus Biosciences Selected Site - Bellevue
- Prometheus Biosciences Selected Site - Tacoma
Kansas
- Prometheus Biosciences Selected Site - Liberty
Missouri
- Prometheus Biosciences Selected Site - St Louis
New Hampshire
- Prometheus Biosciences Selected Site - Lebanon
New York
- Prometheus Biosciences Selected Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2025-05-27 |
| Phase | Phase 2 |
Sponsor
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)6 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05013905
The ClinicalTrials.gov registry entry for NCT05013905 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (73% lower). The listed sponsor is Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which PRA023 IV is the first listed.
NCT05013905 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Texas, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT05013905 about?
NCT05013905 is a clinical study titled "A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease". 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.
What is the current status of trial NCT05013905?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2021-07-28. Estimated completion is 2025-05-27.
What conditions does trial NCT05013905 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT05013905?
The interventions under investigation include: PRA023 IV (DRUG), Companion diagnostic (CDx) (DEVICE).
Who is sponsoring clinical trial NCT05013905?
This trial is sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05013905 being conducted?
This trial has 20 study locations across California, Kansas, Michigan, Missouri, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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