SAR441566 for Psoriasis (SPECIFI-PSO Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sanofi

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It is designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male and female adults with moderate to severe plaque psoriasis. Study details include a screening period (4 weeks and not less than 11 days before Day 1), a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (4 weeks ± 3 days). The total number of study visits will be 7.

Eligibility Criteria

Adults with moderate to severe plaque psoriasis can join this trial. They should have a Psoriasis Area and Severity Index (PASI) score of at least 12, a static Physician's Global Assessment (sPGA) score of at least 3, and body surface area (BSA) affected by psoriasis must be 10% or more. Candidates must weigh over 50 kg with a BMI between 18-35 and be suitable for phototherapy or systemic therapy.

Inclusion Criteria

I weigh at least 110 pounds and my BMI is between 18 and 35.

Treatment Details

The study is testing SAR441566 against a placebo in adults with plaque psoriasis. It's randomized, meaning people are put into the treatment or placebo group by chance, double-blind so neither participants nor researchers know who gets what during the study, and it lasts for about three months plus follow-ups.

6Treatment groups

Experimental Treatment

Placebo Group

Group I: SAR441566 dose regimen EExperimental Treatment1 Intervention

Participants will receive dose regimen E of SAR441566

Group II: SAR441566 dose regimen DExperimental Treatment1 Intervention

Participants will receive dose regimen D of SAR441566

Group III: SAR441566 dose regimen CExperimental Treatment1 Intervention

Participants will receive dose regimen C of SAR441566

Group IV: SAR441566 dose regimen BExperimental Treatment1 Intervention

Participants will receive dose regimen B of SAR441566

Group V: SAR441566 dose regimen AExperimental Treatment1 Intervention