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Can a new infusion drug calm ulcerative colitis?

NCT ID NCT04996797

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether tulisokibart, an experimental drug given by IV infusion, can help people with moderate to severe ulcerative colitis achieve remission. About 178 participants will receive either tulisokibart or a placebo for 12 weeks, with the option to continue treatment for up to 170 weeks. The study measures how many people reach clinical remission, which means less inflammation and fewer symptoms like bleeding and frequent stools. It also tracks side effects to assess the drug's safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tulisokibart (also known as MK-7240 or PRA023), given by IV infusion
What this could lead to
If it works, tulisokibart could offer a new treatment option for people with moderate to severe ulcerative colitis who have not responded to other therapies.
What could go wrong
This is a phase 2 trial, so the drug is still being tested for safety and effectiveness. It may not work for everyone, and side effects are possible.

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

178 people

The number who actually took part.

Started

Jul 2021

Finished

Jul 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: The main inclusion criteria include but are not limited to the following: * Confirmed diagnosis of ulcerative colitis (UC) * Has moderately to severely active UC as defined by 3-component Modified Mayo score * 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 (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has diagnosis of Crohn's disease or indeterminate colitis * Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy * Has current or impending need for colostomy or ileostomy * Has had surgical bowel resection within 3 months before screening * Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed

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Conditions

The condition(s) this trial relates to.

Severe combined immunodeficiency with sensitivity to ionizing radiation ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis

Contacts and locations

Locations

  • Prometheus Biosciences Selected Center

    Mobile, Alabama, 36608, United States

  • Prometheus Biosciences Selected Center

    Budapest, 1135, Hungary

  • Prometheus Biosciences Selected Site

    Phoenix, Arizona, 85006, United States

  • Prometheus Biosciences Selected Site

    Sun City, Arizona, 85351, United States

  • Prometheus Biosciences Selected Site

    Los Angeles, California, 90045, United States

  • Prometheus Biosciences Selected Site

    Los Angeles, California, 90048, United States

  • Prometheus Biosciences Selected Site

    San Diego, California, 92037, United States

  • Prometheus Biosciences Selected Site

    Bristol, Connecticut, 06010, United States

  • Prometheus Biosciences Selected Site

    Atlanta, Georgia, 30010, United States

  • Prometheus Biosciences Selected Site

    Arlington Heights, Illinois, 60005, United States

  • Prometheus Biosciences Selected Site

    Glenview, Illinois, 60026, United States

  • Prometheus Biosciences Selected Site

    Gurnee, Illinois, 60031, United States

  • Prometheus Biosciences Selected Site

    Kansas City, Kansas, 66160, United States

  • Prometheus Biosciences Selected Site

    Liberty, Kansas, 64098, United States

  • Prometheus Biosciences Selected Site

    Baton Rouge, Louisiana, 70809, United States

  • Prometheus Biosciences Selected Site

    Chevy Chase, Maryland, 20815, United States

  • Prometheus Biosciences Selected Site

    Chesterfield, Michigan, 48047, United States

  • Prometheus Biosciences Selected Site

    Lebanon, New Hampshire, 03756, United States

  • Prometheus Biosciences Selected Site

    New York, New York, 10029, United States

  • Prometheus Biosciences Selected Site

    New York, New York, 10065, United States

  • Prometheus Biosciences Selected Site

    Dublin, Ohio, 43016, United States

  • Prometheus Biosciences Selected Site

    Germantown, Tennessee, 38138, United States

  • Prometheus Biosciences Selected Site

    Bedford, Texas, 76022, United States

  • Prometheus Biosciences Selected Site

    Lubbock, Texas, 79424, United States

  • Prometheus Biosciences Selected Site

    Mansfield, Texas, 76063, United States

  • Prometheus Biosciences Selected Site

    San Antonio, Texas, 78229, United States

  • Prometheus Biosciences Selected Site

    Southlake, Texas, 76092, United States

  • Prometheus Biosciences Selected Site

    Tyler, Texas, 75702, United States

  • Prometheus Biosciences Selected Site

    Charlottesville, Virginia, 22903, United States

  • Prometheus Biosciences Selected Site

    Tacoma, Washington, 98405, United States

  • Prometheus Biosciences Selected Site

    Woodville, Adelaide, Australia

  • Prometheus Biosciences Selected Site

    Kingswood, New South Wales, 2747, Australia

  • Prometheus Biosciences Selected Site

    Old Toongabbie, New South Wales, NSW 2146, Australia

  • Prometheus Biosciences Selected Site

    South Brisbane, Queensland, 4101, Australia

  • Prometheus Biosciences Selected Site

    Woolloongabba, Queensland, 4102, Australia

  • Prometheus Biosciences Selected Site

    Adelaide, South Australia, 5000, Australia

  • Prometheus Biosciences Selected Site

    Fitzroy, Victoria, VIC 3065, Australia

  • Prometheus Biosciences Selected Site

    Melbourne, Victoria, VIC 3065, Australia

  • Prometheus Biosciences Selected Site

    Leuven, 3000, Belgium

  • Prometheus Biosciences Selected Site

    Liège, 4000, Belgium

  • Prometheus Biosciences Selected Site

    Calgary, Alberta, T2N 4Z6, Canada

  • Prometheus Biosciences Selected Site

    Vancouver, British Columbia, V6Z2K5, Canada

  • Prometheus Biosciences Selected Site

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Prometheus Biosciences Selected Site

    North York, Ontario, M6A 3B4, Canada

  • Prometheus Biosciences Selected Site

    Brno, Czechia

  • Prometheus Biosciences Selected Site

    Hradec Králové, Czechia

  • Prometheus Biosciences Selected Site

    Olomouc, 779 00, Czechia

  • Prometheus Biosciences Selected Site

    Slaný, Czechia

  • Prometheus Biosciences Selected Site

    Clichy, 92110, France

  • Prometheus Biosciences Selected Site

    Lille, 59037, France

  • Prometheus Biosciences Selected Site

    Nice, 06202, France

  • Prometheus Biosciences Selected Site

    Pierre-Bénite, 69495, 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

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Prometheus Biosciences Selected Site

    Békéscsaba, 5600, Hungary

  • Prometheus Biosciences Selected Site

    Budapest, 1062, Hungary

  • Prometheus Biosciences Selected Site

    Budapest, 1088, Hungary

  • Prometheus Biosciences Selected Site

    Afula, 18341, Israel

  • Prometheus Biosciences Selected Site

    Beersheba, 84100, Israel

  • Prometheus Biosciences Selected Site

    Holon, 58100, Israel

  • Prometheus Biosciences Selected Site

    Jerusalem, 91031, Israel

  • Prometheus Biosciences Selected Site

    Petah Tikva, 49414, Israel

  • Prometheus Biosciences Selected Site

    Bologna, Emilia-Romagna, 40138, Italy

  • Prometheus Biosciences Selected Site

    Milan, Milan, 20132, Italy

  • Prometheus Biosciences Selected Site

    Milan, Milan, 20157, Italy

  • Prometheus Biosciences Selected Site

    Roma, Rome, 00168, Italy

  • Prometheus Biosciences Selected Site

    Poznan, Greater Poland Voivodeship, 61-441, Poland

  • Prometheus Biosciences Selected Site

    Włocławek, Kuuavian-Pomeranian, 87-800, Poland

  • Prometheus Biosciences Selected Site

    Krakow, Lesser Poland Voivodeship, 31-009, Poland

  • Prometheus Biosciences Selected Site

    Wroclaw, Lower Silesian Voivodeship, 40-211, Poland

  • Prometheus Biosciences Selected Site

    Wroclaw, Lower Silesian Voivodeship, 540144, Poland

  • Prometheus Biosciences Selected Site

    Warsaw, Masovia, 04-730, Poland

  • Prometheus Biosciences Selected Site

    Katowice, Silesian, 40-211, Poland

  • Prometheus Biosciences Selected Site

    Krakow, Poland

  • Prometheus Biosciences Selected Site

    Lodz, 93-357, Poland

  • Prometheus Biosciences Selected Site

    Lublin, 20-362, Poland

  • Prometheus Biosciences Selected Site

    Lublin, 20-607, Poland

  • Prometheus Biosciences Selected Site

    Rzeszów, Poland

  • Prometheus Biosciences Selected Site

    Sopot, Poland

  • Prometheus Biosciences Selected Site

    Szczecin, Poland

  • Prometheus Biosciences Selected Site

    Torun, Poland

  • Prometheus Biosciences Selected Site

    Warsaw, Poland

  • Prometheus Biosciences Selected Site

    Wroclaw, Poland

  • Prometheus Biosciences Selected Site

    Prescot, Merseyside, L34 1BH, United Kingdom

  • Prometheus Biosciences Selected Site #2

    Warsaw, Poland

  • Prometheus Biosciences Selected Sites

    London, E11 1NR, United Kingdom

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