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New hope for Crohn's: experimental drug aims to heal the gut

NCT ID NCT06637631

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study tests an experimental drug called SAR441566 in 260 adults with moderate to severe Crohn's disease. Participants will receive different doses of the drug or a placebo for up to 52 weeks to see if it reduces gut inflammation and improves symptoms. The goal is to find a safe and effective treatment to better control this chronic condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Male or female participants aged 18 to 75 years at the time of signing the ICF 2. Confirmed diagnosis of CD for at least 3 months prior to Baseline 3. Confirmed diagnosis of moderate to severe CD as assessed by: * Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader * stool frequency (SF), abdominal pain (AP) score 4. History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies 5. On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX) 6. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Participants with active UC, indeterminate colitis or short bowel syndrome 2. Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement 3. Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of \> 3 bowel resections 4. Participants with stool sample positive for infectious pathogens 5. Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines 6. Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit 7. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex 8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening 9. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening 10. History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit 11. Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit 12. Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition 13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening 14. Participants who received fecal microbial transplantation within 30 days prior to screening 15. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®) 16. Participants who received IV corticosteroids within 14 days prior to screening or during screening period 17. Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening 18. Screening laboratory and other analyses show abnormal results The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

Contacts and locations

Locations

  • Bristol Hospital- Site Number : 8400007

    Bristol, Connecticut, 06010, United States

  • Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014

    Greenville, North Carolina, 27834, United States

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760001

    Salvador, Estado de Bahia, 41820-020, Brazil

  • Clinical Research of Osceola- Site Number : 8400013

    Kissimmee, Florida, 34741, United States

  • Frontier Clinical Research - Uniontown- Site Number : 8400009

    Uniontown, Pennsylvania, 15401, United States

  • GCP Clinical Research- Site Number : 8400004

    Tampa, Florida, 33609, United States

  • GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020

    Sun City, Arizona, 85351, United States

  • GI Alliance - Glenview- Site Number : 8400015

    Glenview, Illinois, 60026, United States

  • Gastro Health & Nutrition- Site Number : 8400003

    Katy, Texas, 77494, United States

  • Gi Alliance - Flowood- Site Number : 8400019

    Flowood, Mississippi, 39232, United States

  • Homestead Associates in Research- Site Number : 8400012

    Homestead, Florida, 33033, United States

  • Hospital Ernesto Dornelles- Site Number : 0760002

    Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

  • Hospital Moinhos de Vento- Site Number : 0760006

    Porto Alegre, Rio Grande do Sul, 90035-902, Brazil

  • Hospital de Clinicas de Porto Alegre- Site Number : 0760007

    Porto Alegre, Rio Grande do Sul, 90035903, Brazil

  • Illinois Gastroenterology Group- Site Number : 8400011

    Gurnee, Illinois, 60031, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1125, Argentina

  • Investigational Site Number : 0320002

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, 1061, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, 1221, Argentina

  • Investigational Site Number : 0320005

    Buenos Aires, 1119, Argentina

  • Investigational Site Number : 0320006

    Buenos Aires, 1280, Argentina

  • Investigational Site Number : 0360001

    South Brisbane, Queensland, 4101, Australia

  • Investigational Site Number : 0360002

    Sydney, New South Wales, 2139, Australia

  • Investigational Site Number : 0360003

    Parkville, Victoria, 3050, Australia

  • Investigational Site Number : 1000001

    Gorna Oryahovitsa, 5100, Bulgaria

  • Investigational Site Number : 1000004

    Sofia, 1431, Bulgaria

  • Investigational Site Number : 1000005

    Sofia, 1680, Bulgaria

  • Investigational Site Number : 1240001

    Calgary, Alberta, T2N 4Z6, Canada

  • Investigational Site Number : 1240003

    Montreal, Quebec, H3H 1E8, Canada

  • Investigational Site Number : 1240005

    Québec, Quebec, G1N 4V3, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8331143, Chile

  • Investigational Site Number : 1520002

    Viña del Mar, Valparaiso, 2540364, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8380456, Chile

  • Investigational Site Number : 1520004

    Talcahuano, Biobio, 2687000, Chile

  • Investigational Site Number : 1520006

    Concepción, Biobio, 4070038, Chile

  • Investigational Site Number : 1520007

    Temuco, La Araucanía, 4781156, Chile

  • Investigational Site Number : 1560001

    Guangzhou, 510080, China

  • Investigational Site Number : 1560002

    Guangzhou, 510655, China

  • Investigational Site Number : 1560003

    Hangzhou, 310016, China

  • Investigational Site Number : 1560004

    Hangzhou, 310009, China

  • Investigational Site Number : 1560005

    Shanghai, 200127, China

  • Investigational Site Number : 1560006

    Shanghai, 200025, China

  • Investigational Site Number : 1560007

    Hefei, 230022, China

  • Investigational Site Number : 1560008

    Changzhou, 213003, China

  • Investigational Site Number : 1560009

    Chongqing, 400013, China

  • Investigational Site Number : 1560010

    Suzhou, 215004, China

  • Investigational Site Number : 1560011

    Nanchang, 330006, China

  • Investigational Site Number : 1560012

    Fuzhou, 350005, China

  • Investigational Site Number : 1910003

    Zagreb, 10000, Croatia

  • Investigational Site Number : 1910004

    Osijek, 31000, Croatia

  • Investigational Site Number : 2030002

    Brno, 636 00, Czechia

  • Investigational Site Number : 2030003

    Brno, 602 00, Czechia

  • Investigational Site Number : 2030004

    Hradec Králové, 500 12, Czechia

  • Investigational Site Number : 2030006

    Prague, 100 34, Czechia

  • Investigational Site Number : 2500001

    Vandœuvre-lès-Nancy, 54511, France

  • Investigational Site Number : 2500002

    Nice, 06202, France

  • Investigational Site Number : 2500003

    Toulouse, 31059, France

  • Investigational Site Number : 2500004

    Saint-Priest-en-Jarez, 42270, France

  • Investigational Site Number : 2500005

    Montpellier, 34295, France

  • Investigational Site Number : 2680001

    Tbilisi, 0144, Georgia

  • Investigational Site Number : 2680002

    Tbilisi, 0160, Georgia

  • Investigational Site Number : 2680003

    Tbilisi, 0172, Georgia

  • Investigational Site Number : 2680004

    Tbilisi, 0180, Georgia

  • Investigational Site Number : 2680005

    Tbilisi, 0159, Georgia

  • Investigational Site Number : 2680006

    Kutaisi, 4600, Georgia

  • Investigational Site Number : 2680007

    Tbilisi, 0102, Georgia

  • Investigational Site Number : 2760001

    Fulda, 36043, Germany

  • Investigational Site Number : 2760002

    Berlin, 12203, Germany

  • Investigational Site Number : 2760004

    Berlin, 10318, Germany

  • Investigational Site Number : 2760005

    Halle, 06108, Germany

  • Investigational Site Number : 2760006

    Ludwigshafen, 67067, Germany

  • Investigational Site Number : 3480001

    Gyöngyös, 3200, Hungary

  • Investigational Site Number : 3480003

    Békéscsaba, 5600, Hungary

  • Investigational Site Number : 3480004

    Tatabánya, 2800, Hungary

  • Investigational Site Number : 3480005

    Szeged, 6720, Hungary

  • Investigational Site Number : 3480006

    Szekszárd, 7100, Hungary

  • Investigational Site Number : 3480008

    Budapest, 1085, Hungary

  • Investigational Site Number : 3480009

    Gyöngyös, 3200, Hungary

  • Investigational Site Number : 3480010

    Eger, 3300, Hungary

  • Investigational Site Number : 3560001

    Jaipur, 302007, India

  • Investigational Site Number : 3560002

    Secunderabad, 500003, India

  • Investigational Site Number : 3560003

    Hyderabad, 500048, India

  • Investigational Site Number : 3560005

    Kolkata, 700020, India

  • Investigational Site Number : 3560006

    Pune, 412201, India

  • Investigational Site Number : 3560007

    Hyderabad, 500032, India

  • Investigational Site Number : 3560009

    Jaipur, 302001, India

  • Investigational Site Number : 3560010

    Surat, 395010, India

  • Investigational Site Number : 3560013

    Surat, 395002, India

  • Investigational Site Number : 3800001

    Padua, Padova, 35128, Italy

  • Investigational Site Number : 3800002

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 3800004

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3800005

    Pisa, 56124, Italy

  • Investigational Site Number : 3800006

    Rome, Roma, 00168, Italy

  • Investigational Site Number : 3800008

    Rome, Roma, 00128, Italy

  • Investigational Site Number : 3800009

    Milan, Milano, 20097, Italy

  • Investigational Site Number : 3920001

    Sakura, Chiba, 285-0841, Japan

  • Investigational Site Number : 3920003

    Bunkyo-Ku, Tokyo, 113-8510, Japan

  • Investigational Site Number : 3920004

    Kashiwa, Chiba, 277-0871, Japan

  • Investigational Site Number : 3920005

    Kitakyushu, Fukuoka, 802-0077, Japan

  • Investigational Site Number : 3920006

    Sapporo, Hokkaido, 004-0041, Japan

  • Investigational Site Number : 3920007

    Sapporo, Hokkaido, 065-0033, Japan

  • Investigational Site Number : 3920008

    Yahaba, Iwate, 028-3695, Japan

  • Investigational Site Number : 3920010

    Sapporo, Hokkaido, 064-0919, Japan

  • Investigational Site Number : 3920011

    Tokyo, 169-0073, Japan

  • Investigational Site Number : 3920012

    Wakayama, 640-8558, Japan

  • Investigational Site Number : 3920013

    Hiroshima, 734-8530, Japan

  • Investigational Site Number : 3920018

    Ōita, 870-0033, Japan

  • Investigational Site Number : 3920019

    Takamatsu, Kagawa-ken, 760-0017, Japan

  • Investigational Site Number : 3920020

    Nagaoka, Niigata, 940-2108, Japan

  • Investigational Site Number : 4100001

    Daegu, Daegu, 41944, South Korea

  • Investigational Site Number : 4100002

    Haeundae-Gu, Busan, 48108, South Korea

  • Investigational Site Number : 4100003

    Daejeon, Daejeon, 34943, South Korea

  • Investigational Site Number : 4800001

    Vacoas, 72218, Mauritius

  • Investigational Site Number : 5280001

    Tilburg, 5022 GC, Netherlands

  • Investigational Site Number : 5280002

    Nijmegen, 6525 GA, Netherlands

  • Investigational Site Number : 5280003

    Utrecht, 3584 CX, Netherlands

  • Investigational Site Number : 5280004

    Breda, 4818 CK, Netherlands

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number : 6160002

    Sopot, Pomeranian Voivodeship, 81-756, Poland

  • Investigational Site Number : 6160004

    Warsaw, Masovian Voivodeship, 00-332, Poland

  • Investigational Site Number : 6160005

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Investigational Site Number : 6160006

    Lublin, Lublin Voivodeship, 20-582, Poland

  • Investigational Site Number : 6420001

    Timișoara, 300002, Romania

  • Investigational Site Number : 6420003

    Constanța, 900673, Romania

  • Investigational Site Number : 6420004

    Bucharest, 011461, Romania

  • Investigational Site Number : 7240001

    Madrid, 28046, Spain

  • Investigational Site Number : 7240002

    Seville, Sevilla, 41009, Spain

  • Investigational Site Number : 7920001

    Mersin, 33070, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Istanbul, 34899, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    Sanliurfa, 63290, Turkey (Türkiye)

  • Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016

    Charleston, South Carolina, 29401, United States

  • Novum Research- Site Number : 8400021

    Clermont, Florida, 34711, United States

  • Pesquisare Saude- Site Number : 0760004

    Santo André, São Paulo, 09080-110, Brazil

  • Queens Village Primary Medical Center- Site Number : 8400005

    Queens Village, New York, 11428, United States

  • Texas Digestive Disease Consultants - Southlake- Site Number : 8400002

    Southlake, Texas, 76092, United States

  • University of Michigan Health System - Ann Arbor- Site Number : 8400017

    Ann Arbor, Michigan, 48109, United States

  • Vector Clinical Trials- Site Number : 8400001

    Las Vegas, Nevada, 89128, United States

  • Washington Gastroenterology - Tacoma- Site Number : 8400008

    Tacoma, Washington, 98405, United States

  • Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010

    Miami Lakes, Florida, 33016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.