SAR441566 for Ulcerative Colitis

(SPECIFI-UC Trial)

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must not be taking: Cyclosporine, Tacrolimus, Mycophenolate, Thalidomide

Disqualifiers: Active CD, Active TB, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 20

204 Participants Needed

Trial Summary

What is the purpose of this trial?

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 UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who have used certain medications like cyclosporine, tacrolimus, or IV corticosteroids shortly before the trial. It's best to discuss your specific medications with the trial team.

Eligibility Criteria

This trial is for adults with moderate-to-severe ulcerative colitis. Participants must be able to complete a screening, follow a year-long treatment plan, and attend up to 20 clinic visits. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I have had active ulcerative colitis for at least 3 months, confirmed by a recent endoscopy.

My ulcerative colitis is active and severe, scoring 5 to 9 on the Mayo scale.

I have previously been treated for urinary cancer as required.

Exclusion Criteria

Participants with specific ongoing known complications of UC

Participants with specific positive findings in fecal samples

Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4-5 weeks

Induction Treatment

Participants receive induction treatment for 12 weeks to assess initial efficacy and safety

12 weeks

4 visits (in-person)

Maintenance Treatment

Participants continue treatment for 40 weeks to maintain clinical remission

40 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Open-label Extension

Eligible participants may opt into continuation of treatment for up to 40 weeks

40 weeks

8 visits (in-person)

Treatment Details

Interventions

• SAR441566

Trial Overview The study tests SAR441566's effectiveness in achieving clinical remission of ulcerative colitis compared to a placebo. It's double-blind and includes an induction period (12 weeks), maintenance period (40 weeks), followed by an open-label phase for eligible participants.

Participant Groups

Group I: SAR441566 dose regimen 3 Experimental Treatment 1 Intervention

Participants will receive SAR441566 dose regimen 3

Group II: SAR441566 dose regimen 2 Experimental Treatment 1 Intervention

Participants will receive SAR441566 dose regimen 2

Group III: SAR441566 dose regimen 1 Experimental Treatment 1 Intervention

Participants will receive SAR441566 dose regimen 1

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive SAR441566-matching placebo

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University