Study on the Effectiveness and Safety of SAR441566 for Adults with Moderate-to-Severe Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The treatment being tested is called SAR441566. The purpose of the study is to evaluate how effective and safe this treatment is for adults who have moderate-to-severe forms of ulcerative colitis.

Participants in the study will receive different doses of SAR441566 or a placebo to compare the outcomes. The study will monitor participants over a period of time to see if the treatment helps them achieve clinical remission, which means a significant reduction or disappearance of symptoms. The study will also look at other outcomes, such as improvements in symptoms reported by patients and changes observed during medical examinations.

The trial will last for several weeks, and participants will have regular check-ups to assess their progress. The study aims to gather information on how well SAR441566 works and its safety profile, which includes monitoring any side effects that may occur during the treatment period. This information will help determine if SAR441566 could be a beneficial treatment option for people with ulcerative colitis in the future.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the investigational medication SAR441566 or a placebo. A placebo is a substance with no active medication, used to compare the effects of the investigational drug.

2 medication administration

You will receive the medication in a dose that is determined by the study protocol. The exact dosage and frequency will be explained to you by the study team. The medication will be administered over a period of 12 weeks.

3 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include physical examinations and may involve blood tests or other assessments as required by the study protocol.

4 monitoring and assessments

Your progress will be monitored using a scoring system called the modified Mayo Score (mMS), which helps assess the severity of ulcerative colitis. This will be done at the start and at the end of the 12-week period to evaluate the effectiveness of the treatment.

5 end of treatment evaluation

At the end of the 12-week treatment period, your condition will be evaluated to determine if you have achieved clinical remission or response. This involves assessing improvements in symptoms and overall health.

6 follow-up

After completing the treatment phase, there may be additional follow-up visits to monitor your health and gather further data on the long-term effects of the treatment.

Who Can Join the Study?

Participants must be male or female and aged between 18 to 75 years at the time of signing the consent form.
Participants should have active Ulcerative Colitis (UC) for at least 3 months before the screening, confirmed by a procedure called endoscopy during the screening period.
Participants must have moderate-to-severe UC at screening, defined by a specific score called the modified Mayo Score (mMS) of 5 to 9. This score includes:
- A minimum rectal bleeding (RB) subscore of 1.
- A minimum stool frequency (SF) subscore of 1.
- A mMES of 2 or more, confirmed by a central reader.
- A minimum total of all subscores of 5.
- The disease must affect more than 15 cm from the anal verge.
Participants must have received prior treatment for UC, which includes:
- No prior exposure to Advanced Therapy (AT), but having an inadequate response, loss of response, or intolerance to standard treatments like 5-ASA, 6-MP, AZA, MTX, oral or intravenous corticosteroids, or a history of corticosteroid dependence (meaning they cannot reduce corticosteroids without UC coming back).
- Or, an inadequate response, loss of response, or intolerance to treatment with at least one approved AT, such as a biologic agent (like TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or experimental biologic UC treatments), or a small molecule (like a JAKi or S1PRm) for UC.
Participants must use contraception as per local regulations for those taking part in clinical studies.

Who Cannot Join the Study?

Patients with any other significant health condition that might interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of severe allergic reactions.
Patients who are currently participating in another clinical trial.
Patients who have had surgery related to the digestive system in the past 6 months.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have been diagnosed with cancer in the past 5 years, except for skin cancer that is not melanoma.
Patients who have a history of heart disease.
Patients who have uncontrolled high blood pressure.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
IRCCS Humanitas Research Hospital	Rozzano	Italy
Medical University Of Vienna	Vienna	Austria
DRK Kliniken Berlin	Berlin	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Medical University Of Graz	Graz	Austria
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz	Warsaw	Poland
CED Studienzentrum Karlshorst, Dr. med., Thomas Brunk, Gastroenterologie Berlin	Berlin	Germany

Other Sites

Site Name	City	Country
The medical centre Kanev Ltd.	Ruse	Bulgaria
PreventaMed s.r.o.	Olomouc	Czechia
Universitair Ziekenhuis Gent	Gent	Belgium
Klinikum Ernst von Bergmann gGmbH	Potsdam	Germany
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Klinische Forschung Berlin-Mitte GmbH	Berlin	Germany
University General Hospital Of Heraklion	Heraklion	Greece
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Poliklinika Borzan d.o.o.	Osijek	Croatia
Azienda Ospedaliera di Padova	Padua	Italy
KBC Zagreb	Zagreb	Croatia
Nemocnice Slany	Slany	Czechia
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Semmelweis University	Budapest	Hungary
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila	Bucharest	Romania
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Uniklinikum Salzburg	Salzburg	Austria
Medical Center Comac Medical Ltd.	Sofia	Bulgaria
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Sjhx Kmuoyfoq Diytixgb Gpoy	Duisburg	Germany
Eiawqfb slsjlx	Slezska Ostrava	Czechia
Pmkbebgrdvb Gdphjcbfxon Rgyqpa Mtstd	Constanta	Romania
Plabccbsb Bvgaf Kdzkjmolokq Spkgl	Wroclaw	Poland
Aevbwpu Oavzmtukcip Udqhjohpydirp Cdnsaajzmatr Dchdq Slfthn E Drfwz Siyoxwp Dz Tjfrgv	Turin	Italy
Cymg Ds Niaqj	Vandoeuvre Les Nancy	France
Ahpbsrg Odyxrrnzofd Nkgabwvkr Sm Aawmgei E Bvbdzv E C Aqvsgv Axibmxarpia	Alexandria	Italy
Gacoqa Umvfofhswt Fsivobyif	Frankfurt	Germany
Unbmsklkpl Datdu Sieok Db Rvsk Lm Stdgjjav	Rome	Italy
Wzw Wkrqdn Iis Pndkx Pvtipwlh Korzdzj	Warsaw	Poland
Ssqhmpzfmghkdnkzclc Bio Uk (oxojtbjnmyjiuqwoaiaa	Halle (Saale)	Germany
Motcgqvq Svt z owog	Oświęcim	Poland
Tddpjkumgqbr Nfbvsnlobtzknj Guxx	Nordhausen	Germany
Eqxlwbbxlabgbzipfbfajnnanv Hkkwllli op Aqostb	Athens	Greece

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	25.05.2025
Belgium	Recruiting	25.05.2025
Bulgaria	Recruiting	25.05.2025
Croatia	Not yet recruiting	25.05.2025
Czechia	Recruiting	25.05.2025
France	Recruiting	25.05.2025
Germany	Recruiting	25.05.2025
Greece	Recruiting	25.05.2025
Hungary	Recruiting	25.05.2025
Italy	Recruiting	25.05.2025
Poland	Recruiting	25.05.2025
Romania	Not yet recruiting	25.05.2025

Trial locations

SAR441566 is a medication being studied for its potential to help people with moderate-to-severe ulcerative colitis, which is a condition that causes inflammation and sores in the colon. This medication is being tested to see if it can help reduce the symptoms of ulcerative colitis and help patients achieve clinical remission, meaning their symptoms are significantly reduced or disappear. The study is looking at how effective and safe this medication is for people with this condition.

Ulcerative Colitis – Ulcerative Colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. The disease typically begins in the rectum and can extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can lead to frequent and urgent bowel movements. Over time, the disease can cause complications such as severe bleeding or perforation of the colon.

Trial ID:

2025-520705-12-00

Protocol code:

DRI17822

NCT ID:

NCT06867094

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of SAR441566 for Adults with Moderate-to-Severe Ulcerative Colitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?