Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Long-term safety study of tulisokibart in adults with Crohn's disease or ulcerative colitis

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying the long-term effects of tulisokibart (also known as MK-7240) in people who have Crohn's Disease or Ulcerative Colitis. These are two types of inflammatory bowel diseases that cause inflammation in different parts of the digestive system, leading to various digestive symptoms and discomfort.

The study aims to evaluate how safe and effective tulisokibart is when used over an extended period. The medication is given as a subcutaneous injection using a pre-filled injector device that delivers the medicine under the skin. Some participants will receive tulisokibart, while others will receive placebo through the same type of injection device.

The study will last for approximately 364 days (one year), during which participants will receive regular treatments and undergo various medical assessments. This extension study is specifically designed for people who have previously participated in earlier studies of tulisokibart and have shown benefit from the treatment. Throughout the study, doctors will monitor participants' health and how well their digestive condition responds to the continued treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial qualification

    Your participation starts after completing a previous tulisokibart study for Crohn's Disease or Ulcerative Colitis

    The doctor will evaluate if you can benefit from continuing the treatment based on your previous study results

  2. Step 2

    Treatment administration

    You will receive tulisokibart through injections under the skin (subcutaneous use)

    The medication comes in a pre-filled injection device for easier administration

    The treatment period will continue for approximately 364 weeks (7 years)

  3. Step 3

    Health monitoring

    Regular check-ups will monitor your response to the treatment

    The doctor will track any side effects you may experience

    Your disease activity will be measured using specific scoring systems

    You will undergo endoscopic examinations to check the condition of your digestive tract

  4. Step 4

    Safety requirements

    If you were assigned female at birth, you cannot breastfeed during the study and for 14 weeks after the last dose

    If you can become pregnant, you must use approved birth control methods or abstain from sexual activity during the study

    The study will continue until December 2037

Who can join the trial?

8 criteria

  • Must have previously participated in an MSD-sponsored research study (Phase 2 or Phase 3) testing tulisokibart for Crohn's Disease or Ulcerative Colitis
  • Must show clinical benefit from the treatment based on the doctor's evaluation during the previous study
  • Must be an adult (18 years or older)
  • Both men and women can participate
  • Women who can become pregnant must:
    • Not be pregnant during the study
    • Use approved birth control methods or practice abstinence
    • Not breastfeed during treatment and for at least 14 weeks after the last dose
    • Must not belong to any vulnerable population groups (such as people who cannot give informed consent)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Current or previous diagnosis of any autoimmune disease other than Crohn's Disease or Ulcerative Colitis
  • Active or chronic infection, including tuberculosis (TB), hepatitis B, or hepatitis C
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Pregnant or breastfeeding women
  • Major surgery within 8 weeks before the start of the study
  • Participation in another clinical trial within 30 days before this study
  • Severe liver disease (abnormal liver function tests)
  • Severe kidney disease (abnormal kidney function)
  • Uncontrolled high blood pressure
  • History of severe allergic reactions to medications
  • Active substance abuse or drug addiction
  • Mental conditions that could interfere with study compliance
  • Use of live vaccines within 4 weeks before the study start
  • Previous treatment with tulisokibart or similar medications
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Tulisokibart is a new investigational medication being studied for treating people with Crohn's Disease and Ulcerative Colitis, which are inflammatory conditions affecting the digestive system. This medication is designed to help reduce inflammation in the intestines and manage the symptoms of these conditions over a long period of time. The medication is being tested to understand how safe it is and how well it works when used for extended treatment periods.

What is already known about the treatment

Tulisokibart - An investigational medication currently being studied in Phase 3 clinical trials for the treatment of inflammatory bowel diseases, specifically Crohn's Disease and Ulcerative Colitis. This novel therapeutic agent is being evaluated for its long-term safety and efficacy in managing these chronic gastrointestinal conditions. While the exact molecular mechanism is still under investigation in clinical trials, tulisokibart belongs to a class of targeted biological therapies designed to modulate the immune system's response in inflammatory conditions. The medication is being studied to potentially provide a new treatment option for patients who have these challenging autoimmune digestive disorders.

Investigated diseases

  • Crohn's Disease

    A chronic inflammatory condition that can affect any part of the digestive tract, from mouth to anus, but most commonly impacts the small intestine and colon. The inflammation can spread deep into the layers of affected bowel tissue, causing pain, severe diarrhea, and digestive problems. The disease typically develops in patches, with healthy sections in between affected areas. Symptoms can vary from mild to severe and may come and go with periods of active illness followed by remission.

  • Ulcerative Colitis

    A chronic inflammatory bowel disease that causes inflammation and sores (ulcers) in the innermost lining of the large intestine (colon) and rectum. Unlike Crohn's disease, this condition affects only the colon and rectum, with inflammation occurring in a continuous pattern. The disease usually begins in the rectum and spreads upward through the colon. Symptoms typically develop gradually over time rather than suddenly, with periods of active disease alternating with periods of remission.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513533-20-00Protocol codeMK-7240-011Estimated enrolment1 050 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).