A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis

Conditions

• Colitis Ulcerative

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• SAR441566 — DRUG
  Pharmaceutical form: Tablet Route of administration: Oral
• SAR441566 matching Placebo — DRUG
  Pharmaceutical form: Tablet Route of administration: Oral

Study Details

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 (for participants not enrolling in the LTS study). * 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.

Key Dates

Start date

Mar 28, 2025

Status verified

May 2026

Primary completion

Jul 29, 2027

Completion

May 11, 2028

Study Design

Enrollment

204 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SAR441566 dose regimen 1
  Participants will receive SAR441566 dose regimen 1
• Experimental: SAR441566 dose regimen 2
  Participants will receive SAR441566 dose regimen 2
• Experimental: SAR441566 dose regimen 3
  Participants will receive SAR441566 dose regimen 3
• Placebo Comparator: Placebo
  Participants will receive SAR441566-matching placebo

Primary Outcome Measure

Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS) [ Time Frame: Week 12 ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (19)

Find similar trials in Sun City, AZ

Related Studies

• A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
  PHASE2 · Recruiting · Merck Sharp & Dohme LLC · Anaheim, California