A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. (SPECIFI-CD)

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: SAR441566; Drug: SAR441566 matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06637631

2024-512633-32-00 (Registry Identifier)

DRI18212

U1111-1301-3830 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 4 patient groups, including a placebo group

SAR441566 dose 1

Experimental group

Description:

Participants will receive SAR441566 dose 1.

Treatment:

Drug: SAR441566

SAR441566 dose 2

Experimental group

Description:

Participants will receive SAR441566 dose 2.

Treatment:

Drug: SAR441566

SAR441566 dose 3

Experimental group

Description:

Participants will receive SAR441566 dose 3.

Treatment:

Drug: SAR441566

Placebo

Placebo Comparator group

Description:

Participants will receive SAR441566 matching placebo.

Treatment:

Drug: SAR441566 matching Placebo