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New drug shows promise for tough Crohn's cases

NCT ID NCT05013905

Disease control Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tested a new drug called tulisokibart (PRA023) in 55 people with moderate-to-severe Crohn's disease who had not responded well to other treatments. The main goals were to check safety and see if the drug could improve gut healing and reduce symptoms. After 12 weeks, some participants could continue treatment for up to 170 weeks to monitor long-term effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

55 people

The number who actually took part.

Started

Jul 2021

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed diagnosis of Crohn's disease (CD) * 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 the requirements of the study Exclusion Criteria: * Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug * Diagnosis of ulcerative colitis (UC) or indeterminate colitis * CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/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 or previous 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 not completely removed * Participants in the opinion of the investigator are at an unacceptable risk for participation in the study * Participants who meet the protocol criteria for important laboratory exclusion criteria

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease

Contacts and locations

Locations

  • Prometheus Biosciences Selected Center

    Krakow, 31-501, Poland

  • Prometheus Biosciences Selected Center

    Warsaw, 00-635, Poland

  • Prometheus Biosciences Selected Center

    Warsaw, 52-416, Poland

  • Prometheus Biosciences Selected Site

    Los Angeles, California, 90045, United States

  • Prometheus Biosciences Selected Site

    Los Angeles, California, 90048, United States

  • Prometheus Biosciences Selected Site

    Liberty, Kansas, 64098, United States

  • Prometheus Biosciences Selected Site

    Chesterfield, Michigan, 48047, United States

  • Prometheus Biosciences Selected Site

    Ypsilanti, Michigan, 48197, United States

  • Prometheus Biosciences Selected Site

    St Louis, Missouri, 63141, United States

  • Prometheus Biosciences Selected Site

    Lebanon, New Hampshire, 03756, United States

  • Prometheus Biosciences Selected Site

    New York, New York, 10065, United States

  • Prometheus Biosciences Selected Site

    Garland, Texas, 75044, United States

  • Prometheus Biosciences Selected Site

    Lubbock, Texas, 79410, United States

  • Prometheus Biosciences Selected Site

    Lubbock, Texas, 79424, United States

  • Prometheus Biosciences Selected Site

    San Antonio, Texas, 78229, United States

  • Prometheus Biosciences Selected Site

    Southlake, Texas, 78229, United States

  • Prometheus Biosciences Selected Site

    Tyler, Texas, 75702, United States

  • Prometheus Biosciences Selected Site

    Bellevue, Washington, 98004, United States

  • Prometheus Biosciences Selected Site

    Tacoma, Washington, 98405, United States

  • Prometheus Biosciences Selected Site

    Bankstown, New South Wales, 2146, Australia

  • Prometheus Biosciences Selected Site

    Woolloongabba, Queensland, 4102, Australia

  • Prometheus Biosciences Selected Site

    Adelaide, South Australia, 5000, Australia

  • Prometheus Biosciences Selected Site

    Leuven, 3000, Belgium

  • Prometheus Biosciences Selected Site

    Liège, 4000, Belgium

  • Prometheus Biosciences Selected Site

    London, Ontario, N6A 5W9, Canada

  • Prometheus Biosciences Selected Site

    Brno, Czechia

  • Prometheus Biosciences Selected Site

    Slaný, 274 01, Czechia

  • Prometheus Biosciences Selected Site

    Clichy, 92110, France

  • Prometheus Biosciences Selected Site

    Nice, 06202, France

  • Prometheus Biosciences Selected Site

    Saint-Priest-en-Jarez, 42270, France

  • Prometheus Biosciences Selected Site

    Vandœuvre-lès-Nancy, 54511, France

  • Prometheus Biosciences Selected Site

    Tbilisi, Georgia

  • Prometheus Biosciences Selected Site

    Rzeszów, 35-326, Poland

  • Prometheus Biosciences Selected Site

    Sopot, 81-756, Poland

  • Prometheus Biosciences Selected Site

    Torun, 87-100, Poland

  • Prometheus Biosciences Selected Site

    Warsaw, 03-580, Poland

  • Prometheus Biosciences Selected Site

    Wroclaw, 52-416, Poland

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