A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

Last updated: May 17, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Bowel Dysfunction

Ulcerative Colitis

Inflammatory Bowel Disease

Treatment

SAR441566

SAR441566 matching Placebo

Clinical Study ID

NCT06637631
DRI18212
U1111-1301-3830
2024-512633-32-00
  • Ages 18-75
  • All Genders

Study Summary

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.

This study will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks. The MS period include a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. At the end of 52 weeks in the MS period, eligible participants from MS period will be offered a Double-Blind Maintenance Extension (DBME) period for up to 52 weeks.

Additionally, an Open Label (OL) period of up to 92 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 92 weeks, while the sum of the DBME and OL periods may not exceed 52 weeks, depending on when participants switch.

Eligibility Criteria

Inclusion

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 forCrohn's disease (SES-CD) on an endoscopy confirmed by a central reader

  • stool frequency (SF), abdominal pain (AP) score

  1. History of prior exposure to standard treatment (5-ASA, steroids, immunomodulatorsor antibiotics) or advanced therapies (biologics or small molecules), but havinginadequate response to, loss or response to or intolerance to at least one of thesetherapies

  2. On stable doses of standard treatments prior to screening (Oral 5-ASA compounds,Oral corticosteroids, AZA, 6-MP, or MTX ..)

  3. Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.Women participants should not be pregnant or breastfeeding.

Exclusion

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 analregion, without colonic or ileal involvement

  3. Participants with following ongoing known complications of CD: fistula, abscess,symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowelresection 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 treatedactive or latent TB per local guidelines

  6. Participants with Positive Hepatitis B surface antigen (HBsAg) or positive HepatitisB core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the ScreeningVisit

  7. Participants with any other active, chronic or recurrent infection, includingrecurrent or disseminated herpes zoster or disseminated herpes simplex

  8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection orpositive HIV-1 or HIV-2 serology at screening

  9. Participants presenting with active malignancies, lymphoproliferative disease, orrecurrence of either, within the 5 years before screening

  10. Participants with adenomatous colonic polyps or colonic mucosal dysplasia (low- orhigh grade) not excised or incompletely excised

  11. Infection(s) requiring treatment with IV anti infectives within 30 days ororal/intramuscular anti-infectives within 14 days prior to the screening visit

  12. Participants requiring or receiving any parental nutrition and/or exclusive enteralnutrition

  13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, orthalidomide within 30 days prior to screening

  14. Participants who received fecal microbial transplantation within 30 days prior toscreening

  15. Participants who have ever been exposed to natalizumab (Tysabri®) or oralcarotegrast methyl (Carogra®)

  16. Participants who received IV corticosteroids within 14 days prior to screening orduring screening period

  17. Participants who received therapeutic enema or suppository, other than required forcolonoscopy within 14 days prior to screening or during screening

  18. Screening laboratory and other analyses show abnormal results

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: SAR441566
Phase: 2
Study Start date:
December 10, 2024
Estimated Completion Date:
May 23, 2029

Connect with a study center

  • Investigational Site Number : 0320002

    San Miguel de Tucumán, Tucumán 4000
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320001

    Buenos Aires, 1125
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320003

    Buenos Aires, 1061
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320005

    Buenos Aires, 1128
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0360002

    Sydney, New South Wales 2139
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360001

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360003

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Hospital Moinhos de Vento- Site Number : 0760006

    Porto Alegre, Rio Grande Do Sul 90035-902
    Brazil

    Active - Recruiting

  • Investigational Site Number : 1000001

    Gorna Oryahovitsa, 5100
    Bulgaria

    Active - Recruiting

  • Investigational Site Number : 1240001

    Calgary, Alberta T2N 4Z6
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240003

    Montreal, Quebec H3H 1E3
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240005

    Québec City, Quebec G1V 4T3
    Canada

    Active - Recruiting

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana De Santiago 8331143
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520002

    Viña Del Mar, Valparaíso 2540364
    Chile

    Active - Recruiting

  • Investigational Site Number : 1560008

    Changzhou, 213000
    China

    Active - Recruiting

  • Investigational Site Number : 1560009

    Chongqing, 400013
    China

    Active - Recruiting

  • Investigational Site Number : 1560012

    Fuzhou, 350005
    China

    Active - Recruiting

  • Investigational Site Number : 1560001

    Guangzhou, 510080
    China

    Active - Recruiting

  • Investigational Site Number : 1560003

    Hangzhou, 310016
    China

    Active - Recruiting

  • Investigational Site Number : 1560004

    Hangzhou, 310009
    China

    Active - Recruiting

  • Investigational Site Number : 1560007

    Hefei, 230022
    China

    Active - Recruiting

  • Investigational Site Number : 1560011

    Nanchang, 330006
    China

    Active - Recruiting

  • Investigational Site Number : 1560010

    Suzhou, 215004
    China

    Active - Recruiting

  • Investigational Site Number : 1910004

    Osijek, 31000
    Croatia

    Active - Recruiting

  • Investigational Site Number : 2500003

    Toulouse Cedex 9, 31059
    France

    Active - Recruiting

  • Investigational Site Number : 2760002

    Berlin, 12200
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760004

    Berlin, 10318
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760005

    Halle, 06108
    Germany

    Active - Recruiting

  • Investigational Site Number : 3800008

    Roma, Lazio 00128
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800002

    Milan, Milano 20132
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800004

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800001

    Padua, Padova 35128
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800005

    Pisa, 56124
    Italy

    Active - Recruiting

  • Investigational Site Number : 3920004

    Kashiwa, Chiba 277-0871
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920001

    Sakura, Chiba 285-0841
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920006

    Sapporo, Hokkaido 004-0041
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920007

    Sapporo, Hokkaido 065-0033
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920010

    Sapporo, Hokkaido 064-0919
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920008

    Morioka, Iwate 020-8505
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920019

    Takamatsu-shi, Kagawa 760-0017
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920020

    Nagaoka, Niigata 940-2108
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920002

    Osaka-shi, Osaka 530-0011
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920003

    Bunkyo, Tokyo 113-8510
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920011

    Shinjuku-ku, Tokyo 169-0073
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920018

    Oita, 870-0033
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920012

    Wakayama, 640-8558
    Japan

    Active - Recruiting

  • Investigational Site Number : 5280004

    Breda, 4818 CK
    Netherlands

    Active - Recruiting

  • Investigational Site Number : 5280002

    Nijmegen, 6525 GA
    Netherlands

    Active - Recruiting

  • Investigational Site Number : 5280001

    Tilburg, 5022 GC
    Netherlands

    Active - Recruiting

  • Investigational Site Number : 7240002

    Seville, Sevilla 41009
    Spain

    Active - Recruiting

  • Investigational Site Number : 7920001

    Akdeniz, 33070
    Turkey

    Active - Recruiting

  • Investigational Site Number : 7920003

    Istanbul, 34899
    Turkey

    Active - Recruiting

  • Investigational Site Number : 7920002

    Zonguldak, 67000
    Turkey

    Active - Recruiting

  • Connecticut Clinical Research Institute- Site Number : 8400007

    Bristol, Connecticut 06010
    United States

    Active - Recruiting

  • Clinical Research of Osceola- Site Number : 8400013

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Wellness Clinical Research - Miami Lakes- Site Number : 8400010

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • GI Alliance - Glenview- Site Number : 8400015

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • Illinois Gastroenterology Group- Site Number : 8400011

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • GIA Alliance - Flowood - Site Number : 8400019

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • Vector Clinical Trials- Site Number : 8400001

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • A1 Clinical Network- Site Number : 8400005

    New York, New York 11428
    United States

    Active - Recruiting

  • Frontier Clinical Research - Uniontown- Site Number : 8400009

    Uniontown, Pennsylvania 15401
    United States

    Active - Recruiting

  • Frontier Clinical Research, LLC- Site Number : 8400009

    Uniontown, Pennsylvania 15401
    United States

    Active - Recruiting

  • Vitality Digestive Institute Clinical Research- Site Number : 8400003

    Katy, Texas 77494
    United States

    Active - Recruiting

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

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Washington Gastroenterology - Tacoma- Site Number : 8400008

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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