Study of MT-501 in patients with active Crohn’s Disease or Ulcerative Colitis: A Phase 2 safety and effectiveness trial

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What is this study about?

This clinical study focuses on two inflammatory bowel conditions: Crohn’s Disease and Ulcerative Colitis. These are long-term conditions that cause inflammation of the digestive system. The study will test a new medication called MT-501, which comes in the form of film-coated tablets taken by mouth. Some participants will receive MT-501, while others will receive a placebo.

The main goal of this research is to determine if MT-501 is safe and effective for people with moderate to severe forms of these digestive conditions. The study is designed as a Phase 2 platform study, which means it will evaluate multiple treatment approaches for inflammatory bowel disease.

During the study, participants will go through an induction phase where they will take the study medication. Throughout this period, doctors will monitor how well the treatment works by examining the inside of the digestive tract and tracking symptoms. They will also check how the body processes the medication and look for any side effects that may occur. The study will collect information about improvements in the condition of the digestive tract lining and overall disease symptoms.

1 Initial evaluation

The study focuses on participants with active Crohn’s Disease or active Ulcerative Colitis

You must be between 18 and 80 years old to participate

Your condition must be classified as moderately to severely active

Previous treatments with corticosteroids, immunosuppressants, or advanced therapy must have shown insufficient response

2 Treatment phase (Induction Phase)

You will receive either MT-501 or a placebo in the form of film-coated tablets

The medication is taken orally

The treatment period is called the Induction Phase

3 Monitoring during treatment

Your health will be monitored for any side effects or adverse reactions

Laboratory tests will be conducted to check for any abnormal values

For Crohn’s Disease: Your endoscopic response will be evaluated

For Ulcerative Colitis: Your endoscopic improvement will be assessed

4 Final evaluation

The doctor will assess if you have achieved clinical remission (reduction in disease symptoms)

For Ulcerative Colitis: Additional tissue examination will be performed to check for improvement

The effectiveness of the treatment will be measured through specific disease activity scores

The study is expected to continue until May 2027

Who Can Join the Study?

  • Age between 18 and 80 years old
  • Must be able to provide written informed consent and understand study requirements
  • For Ulcerative Colitis patients:
    • Must have confirmed diagnosis of Ulcerative Colitis
    • Must have moderate to severe disease activity
    • Must meet medication stability requirements
  • For Crohn’s Disease patients:
    • Must have confirmed diagnosis of Crohn’s Disease
    • Must have moderate to severe disease activity (measured by CDAI – a disease activity score)
    • Must have moderate to severe disease confirmed by endoscopy (SES-CD score)
    • Must meet medication stability requirements
  • Must have had inadequate response or side effects to previous treatments, including:
    • Corticosteroids (anti-inflammatory medications)
    • Immunosuppressants (medications that reduce immune system activity)
    • Advanced therapies
  • For female participants:
    • Must either be unable to bear children, or
    • Must have a negative pregnancy test during screening
    • Must follow specific birth control requirements during the study

Who Cannot Join the Study?

  • History of cancer or pre-cancerous conditions within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Current severe infections, including active tuberculosis or hepatitis B
  • History of major surgery related to the digestive system in the past 6 months
  • Pregnant or breastfeeding women, or those planning pregnancy during the study period
  • Participation in another clinical trial within the past 30 days
  • Known allergic reactions to similar medications
  • Significant heart, liver, or kidney disease that could interfere with the study
  • Current use of medications that could interact with the study drug
  • Mental health conditions that could affect the ability to follow study procedures
  • History of substance abuse within the past year
  • Unstable or poorly controlled diabetes
  • Blood disorders that could increase risk of complications
  • Unable to undergo required medical procedures or testing
  • History of not following medical treatment plans

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Krankenhaus Waldfriede e.V. Berlin Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Eb Group Sp. z o.o. Warsaw Poland
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j. Staszow Poland
Centrum Medyczne Oporow Wroclaw Poland
Vita Longa Sp. z o.o. Katowice Poland
Centrum Medyczne Med-Gastr Sp. z o.o. Lodz Poland
Endoskopia Sp. z o.o. Sopot Poland
SurGal Clinic s.r.o. Brno-Sever Czechia
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Poliklinika Borzan d.o.o. Osijek Croatia
KBC Zagreb Zagreb Croatia
Melita Medical sp. z o.o. Wroclaw Poland
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Specijalna Bolnica Medico Rijeka Croatia
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Poliklinika Solmed d.o.o. Zagreb Croatia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
EMC Instytut Medyczny S.A. Poznan Poland
Purva Chastna Mbal EOOD Vratsa Vratsa Bulgaria
Irezyj Bonheiden Belgium
Vjozdsbe &cjaa Vdlrugs Sza z ogcn Wroclaw Poland
Nysgapzpv Pzplauenho acyr Prachatice Czechia
Orqbgkx Bajix Kflzpnhulqm Cdzzcxieb Splc Emw Gomhvpghenehj Mbkqavslef Tddzagl Bydgoszcz Poland
Uxvwlpjaus Oz Akswyai Edegem Belgium
Mmhfmphtjvztgbupeuocxomqyuws Remscheid Germany
Mfjofuca Sy z oulj Bydgoszcz Poland
Awweank Ooqpycfrcsb Uqlwocaaisgwz Ctqhzkhtmsfz Dslmp Suvsye E Dchet Suiqmxj Dd Thgvre Turin Italy
Wvc Wucugh Ikl Ppwcb Pdnrphno Kpycnkx Warsaw Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
30.10.2025
Bulgaria Bulgaria
Not yet recruiting
30.10.2025
Croatia Croatia
Not yet recruiting
30.10.2025
Czechia Czechia
Not yet recruiting
30.10.2025
Germany Germany
Not yet recruiting
30.10.2025
Italy Italy
Not yet recruiting
30.10.2025
Poland Poland
Recruiting
30.10.2025
Slovakia Slovakia
Not yet recruiting
30.10.2025

Trial locations

Based on the provided data, I cannot extract specific medications or therapies as they are not included in the source data. The trial appears to be a Phase 2 platform study for multiple therapies in Crohn’s Disease and Ulcerative Colitis patients, but the specific medications are not listed in the provided information.

If you would like a list of medications and their descriptions, please provide additional data that includes the specific treatments being studied in this clinical trial.

Investigated diseases:

Ulcerative Colitis – A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and ulcers in the digestive tract’s innermost lining. It develops gradually and can cause ongoing symptoms including diarrhea with blood or mucus, abdominal pain, and urgency to have bowel movements. The inflammation typically starts in the rectum and can spread continuously to other parts of the colon.

Crohn’s Disease – A chronic inflammatory bowel disease that can affect any part of the digestive tract, from the mouth to the anus. Unlike ulcerative colitis, Crohn’s disease involves inflammation that can spread deep into affected tissues and can occur in patches, with healthy tissue between affected areas. The condition commonly affects the end of the small intestine and the beginning of the colon. Common symptoms include abdominal pain, diarrhea, fatigue, and reduced appetite.

Trial ID:
2025-522001-38-00
Protocol code:
MT-100-201
Trial Phase:
Therapeutic exploratory (Phase II)

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