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

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Klinische Forschung Berlin-Mitte GmbH	Berlin	Germany
Semmelweis University	Budapest	Hungary
Centre Hospitalier Universitaire De Nice	Nice	France
Ajdlggg Oluemuwenwv di Pcnxxm	Padua	Italy
Enxylrdhdtrdryvayrzoopwgpa Hnfumxcj ox Ataibi	Athens	Greece
Udptwyebvsmhcylfdcmid Tszyimpdv Apa	Tuebingen	Germany
Iufpc Ovlgvhxv Pocektygtkb Swq Mewadjv	Genoa	Italy
Adducsw Owmkjljjfzq Uytxppgbzfgmg Cnduswrcrdva Diyix Sorjfz E Dyezn Swolyhu Dz Thilom	Turin	Italy
Atfzweg Oltntrghlzw Urrvarjifcnub Fxdswlgo Ix Dz Nxobzt	Naples	Italy
Cegc Do Noekp	Vandoeuvre Les Nancy	France
Urvdqqvpil Dygpn Seqsn Dj Rggr Lg Syeuhvmf	Rome	Italy
Ukrnmgwbghnz Zfwzfotibo Gxco	Gent	Belgium
Udoyabcpdi Gtdxrrw Hxhqoquf Of Hhdiguyiw	Heraklion	Greece
Fdcumematb Iyqkp Snx Gvihevt Dya Trackhp	Monza	Italy
Uizhairtgti Stuxnhsi	Salzburg	Austria
Ugzlqqprrz Gtptrpe Hpregarw Arnlrpa Gssgjhx Hesbshxr Od Wcdv Auntpu H Azws Vmggrrd	Chaidari	Greece
Azsselm Omzrsvylxbx Ufmcfanwtcaxt Pajkyy	Pisa	Italy
Kcs Zqombb	Zagreb	Croatia
Sjdi Kbuchvkj Drwdmhsq Gkit	Duisburg	Germany
Nwslfpwjj Suhel	Slany	Czechia
Tqpyzmfftkjj Nmrpegxsjkqkgk Goyy	Nordhausen	Germany
Eilkjtd scvdhd	Slezska Ostrava	Czechia
Paxleqyhi Blvmk Kuqbmgkukcj Sdoki	Wroclaw	Poland
Pxzjosjbuxu Gboiyvawhwg Rxeaue Mpzlv	Constanta	Romania
Thh muowncn ctpgcb Khejs Leor	Ruse	Bulgaria
Mzmytss Cqdrbt Cqtcg Mhssfgz Lyxf	Sofia	Bulgaria
Ambsela Oogkrwupava Nsuftcbhz Sn Aiwxrax E Bkrhgx E C Axrhvn Aonbhipxfqy	Alexandria	Italy
Gadpsm Uzigblzzev Ftrnwoklt	Frankfurt	Germany
Suthkbid Ugxhvndmzqh Dw Uzgilzo Mubrriv Cfuugxt Dil Cdybw Dcutab	Bucharest	Romania
Ckfvqya Musrpdcb Mfgtm Sns z omcd	Rzeszow	Poland
Piystzyxgnm szeqrp	Olomouc	Czechia
Kudxdylj Eupoq vsn Bsxwdjsk gthcu	Potsdam	Germany
Amszzsp Omnauldryga Usyupidtkpbhf Pnynprjwcpd Pahsf Ggtdyujv	Palermo	Italy
Pgkfwjircmr Bavgbe dpiuvu	Osijek	Croatia
Samfkqdxqkojetzpohi Bma Uy (fnjqauvpbnscynhuvfiy	Halle (Saale)	Germany
Mtrxgzfo Suh z ovjy	Oświęcim	Poland
Wfd Wuluph Izk Pznsc Prlmaseo Kdueewz	Warsaw	Poland
Iybgrxow fqgx Ktkjvomkn Twolcicamnkgxpvjota usk Ialedbjvozps Uwd gsidd	Ulm	Germany
Mmhurrbdhmigs Hhxcehel fmq Auftuo Tpjgwukjo Hjqrq agt Bnukn Epk	Pleven	Bulgaria

Trial status

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