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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Futuremeds Sp. z o.o. Wroclaw Poland
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Warsaw Poland

Other Sites

Site Name City Country Status
Sonomed Sp. z o.o. Szczecin Poland
Eb Group Sp. z o.o. Warsaw Poland
Centrum Medyczne Oporow Wroclaw Poland
Vita Longa Sp. z o.o. Katowice Poland
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Rivermed Sp. z o.o. Poznan Poland
Bonifraterskie Centrum Medyczne Sp. z o.o. Lodz Poland
Melita Medical sp. z o.o. Wroclaw Poland
Semmelweis University Budapest Hungary
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nice Nice France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. Wloclawek Poland
Medrise Sp. z o.o. Lublin Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Ctnb Df Nulmb Vandoeuvre Les Nancy France
Wey Wqhrcj Ief Pfzyp Pkmqwuyl Knvclry Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
25.02.2025
France France
Recruiting
25.02.2025
Hungary Hungary
Recruiting
25.02.2025
Poland Poland
Recruiting
25.02.2025

Trial locations

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.

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 ID:
2024-513533-20-00
Protocol code:
MK-7240-011
Trial Phase:
Therapeutic confirmatory (Phase III)

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