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

Phase 2

Recruiting

• Conditions: Crohn's Disease
• Interventions: Drug: SAR441566; Drug: SAR441566 matching Placebo

• Registration Number: NCT06637631
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Study Start: 2024-12-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-07-21
• Study Completion: 2029-05-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAR441566 dose 1	SAR441566	Participants will receive SAR441566 dose 1.
SAR441566 dose 3	SAR441566	Participants will receive SAR441566 dose 3.
SAR441566 dose 2	SAR441566	Participants will receive SAR441566 dose 2.
Placebo	SAR441566 matching Placebo	Participants will receive SAR441566 matching placebo.

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving endoscopic response	Week 12	Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD).; The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)	Week 12	CDAI clinical remission is defined as CDAI score \<150. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission	Week 12	PRO 2 remission is defined as the unweighted CDAI component of daily abdominal pain (AP) score ≤1, and the unweighted CDAI component of daily average stool frequency (SF) score ≤3 (ie, AP ≤1 and SF ≤3 and no worsening from baseline).
Proportion of participants achieving both clinical remission and endoscopic response	Week 12	Clinical remission and endoscopic response based on CDAI \<150 and ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD)
Proportion of participants achieving endoscopic remission based on centrally read SES-CD	From Baseline to Week 12	Endoscopic remission is defined as a centrally read SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease from baseline ≥2 points with no SES-CD sub score \>1 point
Proportion of participants achieving CDAI clinical response	From Baseline to Week 12	CDAI clinical response is defined as a CDAI reduction from baseline ≥100 points.
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission	Week 12	IBDQ remission is defined as IBDQ total score ≥170 points. The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life.
Proportion of participants achieving IBDQ response	From baseline to Week 12	IBDQ response defined as an improvement of IBDQ scores by 27 points or more at Week 12 compared with baseline
Change from baseline in the IBDQ scores	From Baseline to week 12	The total IBDQ score ranges from 32 to 224 which indicates better quality of life. A positive change from Baseline indicates improvement.
Plasma pre-dose concentrations of SAR441566 at selected visits	Up to week 104
Plasma post-dose concentrations of SAR441566 at selected visits	Up to week 104
Number of participants experiencing any TEAEs	From week 12 to week 104	Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind maintenance extension and open-label treatment periods

Trial Locations

Locations (65)

Investigational Site Number : 0320002; 🇦🇷 San Miguel de Tucumán, Tucumán, Argentina

Investigational Site Number : 0320001; 🇦🇷 Buenos Aires, Argentina

Hospital Moinhos de Vento- Site Number : 0760006; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Investigational Site Number : 1000001; 🇧🇬 Gorna Oryahovitsa, Bulgaria

Investigational Site Number : 1240003; 🇨🇦 Montreal, Quebec, Canada

Investigational Site Number : 1240005; 🇨🇦 Québec City, Quebec, Canada

Investigational Site Number : 1560012; 🇨🇳 Fuzhou, China

Investigational Site Number : 1560003; 🇨🇳 Hangzhou, China

Investigational Site Number : 1560007; 🇨🇳 Hefei, China

Investigational Site Number : 2500003; 🇫🇷 Toulouse Cedex 9, France

Investigational Site Number : 3800002; 🇮🇹 Milan, Milano, Italy

Investigational Site Number : 3800004; 🇮🇹 Rozzano, Milano, Italy

Investigational Site Number : 3800005; 🇮🇹 Pisa, Italy

Investigational Site Number : 3920007; 🇯🇵 Sapporo, Hokkaido, Japan

Investigational Site Number : 3920008; 🇯🇵 Morioka, Iwate, Japan

Investigational Site Number : 3920019; 🇯🇵 Takamatsu-shi, Kagawa, Japan

Investigational Site Number : 3920003; 🇯🇵 Bunkyo, Tokyo, Japan

Investigational Site Number : 3920011; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Investigational Site Number : 3920018; 🇯🇵 Oita, Japan

Connecticut Clinical Research Institute- Site Number : 8400007; 🇺🇸 Bristol, Connecticut, United States

Clinical Research of Osceola- Site Number : 8400013; 🇺🇸 Kissimmee, Florida, United States

Wellness Clinical Research - Miami Lakes- Site Number : 8400010; 🇺🇸 Miami Lakes, Florida, United States

GI Alliance - Glenview- Site Number : 8400015; 🇺🇸 Glenview, Illinois, United States

Illinois Gastroenterology Group- Site Number : 8400011; 🇺🇸 Gurnee, Illinois, United States

GIA Alliance - Flowood - Site Number : 8400019; 🇺🇸 Flowood, Mississippi, United States

Vector Clinical Trials- Site Number : 8400001; 🇺🇸 Las Vegas, Nevada, United States

A1 Clinical Network- Site Number : 8400005; 🇺🇸 New York, New York, United States

Frontier Clinical Research - Uniontown- Site Number : 8400009; 🇺🇸 Uniontown, Pennsylvania, United States

Vitality Digestive Institute Clinical Research- Site Number : 8400003; 🇺🇸 Katy, Texas, United States

Texas Digestive Disease Consultants - Southlake- Site Number : 8400002; 🇺🇸 Southlake, Texas, United States

Investigational Site Number : 0360003; 🇦🇺 Parkville, Victoria, Australia

Investigational Site Number : 1240001; 🇨🇦 Calgary, Alberta, Canada

Investigational Site Number : 1520001; 🇨🇱 Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520002; 🇨🇱 Viña Del Mar, Valparaíso, Chile

Investigational Site Number : 1560008; 🇨🇳 Changzhou, China

Washington Gastroenterology - Tacoma- Site Number : 8400008; 🇺🇸 Tacoma, Washington, United States

Investigational Site Number : 0320005; 🇦🇷 Buenos Aires, Argentina

Investigational Site Number : 0360002; 🇦🇺 Sydney, New South Wales, Australia

Investigational Site Number : 0360001; 🇦🇺 South Brisbane, Queensland, Australia

Investigational Site Number : 0320003; 🇦🇷 Buenos Aires, Argentina

Investigational Site Number : 1560009; 🇨🇳 Chongqing, China

Investigational Site Number : 1560001; 🇨🇳 Guangzhou, China

Investigational Site Number : 1560004; 🇨🇳 Hangzhou, China

Investigational Site Number : 1560011; 🇨🇳 Nanchang, China

Investigational Site Number : 1560010; 🇨🇳 Suzhou, China

Investigational Site Number : 1910004; 🇭🇷 Osijek, Croatia

Investigational Site Number : 2760005; 🇩🇪 Halle, Germany

Investigational Site Number : 2760004; 🇩🇪 Berlin, Germany

Investigational Site Number : 2760002; 🇩🇪 Berlin, Germany

Investigational Site Number : 3800008; 🇮🇹 Roma, Lazio, Italy

Investigational Site Number : 3800001; 🇮🇹 Padua, Padova, Italy

Investigational Site Number : 3920004; 🇯🇵 Kashiwa, Chiba, Japan

Investigational Site Number : 3920001; 🇯🇵 Sakura, Chiba, Japan

Investigational Site Number : 3920006; 🇯🇵 Sapporo, Hokkaido, Japan

Investigational Site Number : 3920010; 🇯🇵 Sapporo, Hokkaido, Japan

Investigational Site Number : 3920020; 🇯🇵 Nagaoka, Niigata, Japan

Investigational Site Number : 3920002; 🇯🇵 Osaka-shi, Osaka, Japan

Investigational Site Number : 3920012; 🇯🇵 Wakayama, Japan

Investigational Site Number : 5280004; 🇳🇱 Breda, Netherlands

Investigational Site Number : 5280002; 🇳🇱 Nijmegen, Netherlands

Investigational Site Number : 5280001; 🇳🇱 Tilburg, Netherlands

Investigational Site Number : 7240002; 🇪🇸 Seville, Sevilla, Spain

Investigational Site Number : 7920001; 🇹🇷 Akdeniz, Turkey

Investigational Site Number : 7920003; 🇹🇷 Istanbul, Turkey

Investigational Site Number : 7920002; 🇹🇷 Zonguldak, Turkey