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COMPLETED Phase 2

A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

NCT05013905 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 55 participants
Start Date 2021-07-28
Est. Completion 2025-05-27
Phase Phase 2

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05013905 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05013905?

The interventions under investigation include: PRA023 IV (DRUG), Companion diagnostic (CDx) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial