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

Last updated: June 26, 2025
Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

PRA023 IV

Companion diagnostic (CDx)

Clinical Study ID

NCT05013905
PR200-103
2021-000092-37
7240-006
2023-509742-35-00
U1111-1309-6108
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of Crohn's disease

  • Moderately to severely active CD as defined by Crohn's disease activity index (CDAI)score and centrally read endoscopy

  • Must have corticosteroid dependence or have had no response, insufficient response,loss of response and/or intolerance to at least one of the following therapies:corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF),anti-integrin, or anti-interleukin (IL)12/23

  • Able to provide written informed consent and understand and comply with therequirements of the study

Exclusion

Exclusion Criteria:

  • Women of child bearing potential (WOCBP) and men with female partner of childbearingpotential who are unwilling to use two highly effective methods of contraception toavoid pregnancy for the entire study period and up to 12 weeks after the last doseof study drug

  • Diagnosis of ulcerative colitis (UC) or indeterminate colitis

  • CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonicand/or illeal involvement

  • Suspected or diagnosed intra-abdominal or perianal abscess at screening

  • Current stoma or need for colostomy or ileostomy

  • Previous small bowel resection with a combined resected length of >100 cm orprevious colonic resection of > 2 segments

  • Surgical bowel resection within 3 months before screening

  • Past or current evidence of definite low-grade or high-grade colonic dysplasia notcompletely removed

  • Subjects in the opinion of the investigator are at an unacceptable risk forparticipation in the study

  • Subjects who meet the protocol criteria for important laboratory exclusion criteria

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: PRA023 IV
Phase: 2
Study Start date:
July 28, 2021
Estimated Completion Date:
May 27, 2025

Connect with a study center

  • Prometheus Biosciences Selected Site

    Bankstown, New South Wales 2146
    Australia

    Site Not Available

  • Prometheus Biosciences Selected Site

    Old Toongabbie, New South Wales 2146
    Australia

    Site Not Available

  • Prometheus Biosciences Selected Site

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Prometheus Biosciences Selected Site

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Prometheus Biosciences Selected Site

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Prometheus Biosciences Selected Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Prometheus Biosciences Selected Site

    Liège, 4000
    Belgium

    Site Not Available

  • Prometheus Biosciences Selected Site

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Prometheus Biosciences Selected Site

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Prometheus Biosciences Selected Site

    Brno,
    Czechia

    Site Not Available

  • Prometheus Biosciences Selected Site

    Slaný, 274 01
    Czechia

    Site Not Available

  • Prometheus Biosciences Selected Site

    Clichy, 92110
    France

    Site Not Available

  • Prometheus Biosciences Selected Site

    Nice, 06202
    France

    Site Not Available

  • Prometheus Biosciences Selected Site

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • Prometheus Biosciences Selected Site

    Vandœuvre-lès-Nancy, 54511
    France

    Site Not Available

  • Prometheus Biosciences Selected Site

    Tbilisi,
    Georgia

    Site Not Available

  • Prometheus Biosciences Selected Center

    Kraków, 31-501
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Rzeszów, 35-326
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Sopot, 81-756
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Toruń, 87-100
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Center

    Warsaw, 00-635
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Warsaw, 03-580
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Wrocław, 52-416
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Łódź, 93-357
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Kyiv,
    Ukraine

    Site Not Available

  • Prometheus Biosciences Selected Site

    Los Angeles, California 90045
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Liberty, Kansas 64098
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    New York, New York 10065
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Garland, Texas 75044
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Lubbock, Texas 79410
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Southlake, Texas 78229
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Tyler, Texas 75702
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Tacoma, Washington 98405
    United States

    Site Not Available

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