Study of SAR444336 in Adults with Microscopic Colitis Who Achieved Clinical Remission with Budesonide Treatment

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What is this study about?

This study focuses on people with microscopic colitis, a digestive system condition that causes inflammation of the large intestine. The study will test a new medication called SAR444336 in patients who have achieved remission (improvement of symptoms) while using budesonide, a steroid medication. The main purpose is to determine if SAR444336 can help maintain remission without the need for continued steroid treatment.

The study will compare SAR444336 to a placebo in patients whose microscopic colitis symptoms are currently under control with budesonide treatment. SAR444336 is given as a solution for injection that is administered under the skin (subcutaneous use). The treatment period will last for 20 weeks.

During the study, researchers will monitor how well participants maintain their improvement without using steroids. They will also track any side effects that may occur and measure how the body responds to the new medication. The study is designed so that neither the participants nor the doctors know who is receiving SAR444336 or placebo during the treatment period.

1 Initial treatment phase

You will receive SAR444336 or placebo (an inactive substance) through subcutaneous injection (under the skin).

During this phase, your current budesonide treatment will be gradually discontinued.

The treatment assignment is random and neither you nor the study staff will know which treatment you are receiving.

2 Regular monitoring period

Your condition will be monitored to assess if you maintain clinical remission (absence of symptoms) without steroid medication.

Medical staff will track any side effects or reactions to the study medication.

Blood samples will be collected to measure the levels of SAR444336 in your blood.

The presence of antibodies (immune system proteins) against the study medication will be monitored.

3 Safety assessments

Regular checks will be performed to monitor for any side effects or adverse reactions.

Your overall health status will be evaluated throughout the study.

Any changes in your microscopic colitis symptoms will be documented.

4 Study completion

The study will continue until May 2027.

A final evaluation will assess your response to the treatment.

Your participation may end earlier if you experience significant side effects or if your condition worsens.

Who Can Join the Study?

Must have a confirmed diagnosis of microscopic colitis (a condition causing inflammation in the large intestine) verified through tissue examination
Must be currently taking budesonide (an anti-inflammatory steroid medication)
Must be in clinical remission (having no active symptoms) for at least 2 weeks before the screening visit
Must have experienced at least one relapse (return of symptoms) of microscopic colitis in the past 8 months that required treatment with budesonide
Must have a body mass index (BMI) between 18 and 35 kg/m² at the screening visit. BMI is a measure that uses your height and weight to determine if your weight is healthy
Must use appropriate contraceptive methods that comply with local regulations
Must be an adult (18 years or older)
Can be either male or female

Who Cannot Join the Study?

History of inflammatory bowel disease (chronic conditions affecting the digestive tract) other than microscopic colitis
Current or recent treatment with systemic corticosteroids (anti-inflammatory medications taken as pills or injections) within 4 weeks before starting the study
Active or recent gastrointestinal infection within 8 weeks before the study
History of major intestinal surgery or planned surgery during the study period
Current diagnosis of cancer or history of cancer within the past 5 years
Severe liver disease or abnormal liver function tests
Uncontrolled high blood pressure or significant heart disease
Active or chronic infection, including tuberculosis or hepatitis B or C
Pregnancy or breastfeeding
Participation in another clinical trial within 30 days before this study
Known allergies to the study medication or its components
Conditions that could interfere with study participation or evaluation of results
Unable to provide informed consent or follow study procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Universitair Ziekenhuis Gent	Gent	Belgium
Klinikum Ernst von Bergmann gGmbH	Potsdam	Germany
Region Stockholm – SLSO	Stockholm	Sweden
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Azienda Ospedaliera di Padova	Padua	Italy
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Semmelweis University	Budapest	Hungary
Region Midtjylland	Aarhus	Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
CGBS GbR	Frankfurt	Germany
Ejbtt Sjmjeqqydjvor Hkcbvdjw	Stockholm	Sweden
Sro Mnhafd Utj Scj Acngbxejpqagorzgrqqud	Ludwigshafen Am Rhein	Germany
Crfhor Hooohhncvyk Idhsvfawikuhg Lj Rtolpxyanjmrwexmv	Monfermeil	France
Mwjqdtas Sr z oeor	Bydgoszcz	Poland
Hxdjcm Hqjjmyju	Herlev	Denmark
Awhiojx Ocuhygdrpqu Uoiunvbfydpdt Caxbkplczznj Dfciw Snulnv E Dhcgx Suuvwig Da Tjrbzb	Turin	Italy
Pnmwnfakj Ieiuqvqj Mgqvamfh Mcgghbpyakqc Sqbda Wbydtgvwyazi I Ahgkjzjwxnezj	Warsaw	Poland
Whv Wuafpz Itp Pxqjl Pqzudnnp Kooabuj	Warsaw	Poland
Iivjraoy Ookbktdgjenpvdr Dc llgkungmapxjy Jjclt Vttpt	Nantes	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.10.2025
Denmark	Recruiting	15.10.2025
France	Recruiting	15.10.2025
Germany	Recruiting	15.10.2025
Hungary	Recruiting	15.10.2025
Italy	Recruiting	15.10.2025
Poland	Recruiting	15.10.2025
Sweden	Recruiting	15.10.2025

Trial locations

Investigated drugs:

SAR444336

SAR444336
An experimental medication being studied for treating microscopic colitis, a condition that causes inflammation in the intestines. This medication is being tested as a potential steroid-free treatment option for patients who have achieved remission with budesonide.

Budesonide
A corticosteroid medication used to treat inflammation in the intestines. It helps control symptoms of microscopic colitis and bring the condition into remission. In this study, patients will have already achieved remission using this medication before starting the experimental treatment.

Microscopic Colitis – A chronic inflammatory condition affecting the large intestine (colon) that causes persistent watery diarrhea. The condition is characterized by inflammation that can only be seen when tissue from the colon is examined under a microscope. There are two main types: collagenous colitis and lymphocytic colitis, both causing similar symptoms. The inflammation leads to changes in how the colon absorbs and secretes water, resulting in chronic diarrhea. The condition typically develops gradually and can affect daily activities through frequent bowel movements.

Trial ID:

2024-519495-83-00

Protocol code:

ACT18053

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of SAR444336 in Adults with Microscopic Colitis Who Achieved Clinical Remission with Budesonide Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?