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New drug tulisokibart tested for long-term safety in bowel disease patients

NCT ID NCT06651281

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 2 times

Summary

This study looks at the long-term safety of a medicine called tulisokibart for people with moderate to severe Crohn's disease or ulcerative colitis. It is an extension study, meaning participants must have already taken tulisokibart in a previous study. The main goal is to see how many people have side effects and how well they tolerate the drug over time.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2037

An estimate. End dates often move.

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC * The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study * A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention * A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention * A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) Exclusion Criteria: * Has prematurely discontinued study intervention in their parent study * Has received any protocol-specified prohibited medications during their parent study * Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

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

Colitis ulcerative Crohn disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    34 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • 1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)

    RECRUITING

    Lublin, Lublin Voivodeship, 20-059, Poland

  • ARENSIA Exploratory Medicine Georgia ( Site 1104)

    RECRUITING

    Tbilisi, 0112, Georgia

  • BVL Research - Kansas ( Site 0292)

    RECRUITING

    Liberty, Missouri, 64068, United States

  • Bonifraterskie Centrum Medyczne ( Site 2207)

    RECRUITING

    Lodz, Łódź Voivodeship, 93-357, Poland

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)

    RECRUITING

    Békéscsaba, Bekes County, 5600, Hungary

  • CHRU De Nancy - Hopital de Brabois ( Site 1001)

    RECRUITING

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

  • CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)

    RECRUITING

    Neuilly-sur-Seine, Hauts-de-Seine, 92200, France

  • Caprock Gastro Research ( Site 0293)

    RECRUITING

    Lubbock, Texas, 79424, United States

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)

    RECRUITING

    Nice, Alpes-Maritimes, 06202, France

  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)

    RECRUITING

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland

  • Centrum Medyczne Oporow ( Site 2212)

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

  • Connecticut Clinical Research Institute ( Site 0297)

    RECRUITING

    Bristol, Connecticut, 06010, United States

  • EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202)

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-189, Poland

  • GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)

    RECRUITING

    Garland, Texas, 75044, United States

  • GI Alliance - Lubbock ( Site 0288)

    RECRUITING

    Lubbock, Texas, 79410, United States

  • GI Alliance - Southlake ( Site 0298)

    RECRUITING

    Southlake, Texas, 76092-9167, United States

  • Hepato-Gastroenterologie HK ( Site 0700)

    RECRUITING

    Hradec Králové, 50012, Czechia

  • Hopital Claude Huriez CHRU LILLE ( Site 1004)

    RECRUITING

    Lille, Nord, 59037, France

  • Krakowskie Centrum Medyczne ( Site 2210)

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • MAC Research - Merseyside ( Site 3401)

    RECRUITING

    Prescot, Knowsley, L34 1BH, United Kingdom

  • Medrise Sp. z o.o. ( Site 2200)

    RECRUITING

    Lublin, Lublin Voivodeship, 20-582, Poland

  • Melita Medical Sp. z o.o. ( Site 2204)

    ACTIVE_NOT_RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 53-611, Poland

  • New York Gastroenterology Associates ( Site 0253)

    RECRUITING

    New York, New York, 10075, United States

  • Przychodnia Futuremeds Wroclaw ( Site 2211)

    ACTIVE_NOT_RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 53-673, Poland

  • Rivermed Sp. z.o.o. ( Site 2206)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 61-441, Poland

  • Semmelweis Egyetem ( Site 1400)

    RECRUITING

    Budapest, 1082, Hungary

  • Sonomed Sp. z o. o. ( Site 2203)

    RECRUITING

    Szczecin, West Pomeranian Voivodeship, 71-685, Poland

  • Southern Star Research Institute ( Site 0299)

    RECRUITING

    San Antonio, Texas, 78229, United States

  • St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Tyler Research Institute ( Site 0294)

    RECRUITING

    Tyler, Texas, 75701, United States

  • University of Virginia Health System ( Site 0291)

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Vita Longa Sp. Zoo ( Site 2213)

    RECRUITING

    Katowice, Silesian Voivodeship, 40-748, Poland

  • Vivamed Sp. z o.o. ( Site 2201)

    RECRUITING

    Warsaw, Masovian Voivodeship, 03-580, Poland

  • Vojenská Nemocnice Brno-Internal department ( Site 0701)

    RECRUITING

    Brno, Brno-mesto, 615 00, Czechia

  • WIP Warsaw IBD Point Professor Kierkus ( Site 2209)

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-501, Poland

  • Washington Gastroenterology - Tacoma ( Site 0295)

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Whipps Cross University Hospital ( Site 3400)

    ACTIVE_NOT_RECRUITING

    London, England, E11 1NR, United Kingdom

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