SAR441566 for Psoriasis (SPECIFI-PSO Trial)

Phase 2

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Total body weight ≥ 50 kg (110 lb) and body mass index (BMI) within the range [18 - 35] kg/m^2 (inclusive)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 16

Summary

This trial assesses the effectiveness of a drug for adults with moderate-severe plaque psoriasis. 7 visits over 12 weeks + 2 wks follow-up. Double-blind, placebo-controlled.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical ones from treatments like SAR441566 may include reactions at the injection site, cold symptoms, headache, fatigue, stomach issues and potential risks to liver health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at week 12

Secondary study objectives

Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)

Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) at week 12