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Monoclonal Antibodies

SAR441566 for Psoriasis (SPECIFI-PSO Trial)

Phase 2

Recruiting

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 week 2 to week 12

Awards & highlights

SPECIFI-PSO Trial 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.Check my eligibility

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.See study design

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.

SPECIFI-PSO Trial 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.

SPECIFI-PSO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2 to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2 to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

PASI change from baseline to week 12

Plasma post-dose concentrations of SAR441566

+2 more

SPECIFI-PSO Trial Design

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

Participants will receive dose regimen A of SAR441566

Group VI: PlaceboPlacebo Group1 Intervention

Participants will receive SAR441566 matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAR441566

2023

Completed Phase 1

~110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,773 Total Patients Enrolled

1 Trials studying Psoriasis

38 Patients Enrolled for Psoriasis

Clinical Sciences and OperationsStudy DirectorSanofi

6 Previous Clinical Trials

90,060 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any new participants being sought for this research endeavor?

"Per the data hosted on clinicaltrials.gov, this investigation is actively looking for participants. The trial was initially published on October 26th 2023 and underwent its latest revision a few weeks later on November 29th 2023."

Answered by AI

What is the aggregate population size of individuals participating in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical trial was initially posted on October 26th 2023 and is currently enrolling participants. Around 207 patients must be outreached at 3 distinct locations."

Answered by AI

Is the age limit for recruitment to this trial above 55 years?

"The minimum age of admission for this trial is 18, while the cut-off age is 75."

Answered by AI

Has the FDA sanctioned SAR441566 dose regimen E?

"Our team has assigned SAR441566 dose regimen E a risk level of 2 due to the available safety data gathered in Phase 2 trials, although no efficacy evidence is present."

Answered by AI

Are my criteria sufficient to qualify me for participation in this research?

"The current clinical trial is seeking 207 individuals aged 18-75 suffering from psoriasis. To qualify, patients must have a PASI score of at least 12 points, an sPGA score of 3 or higher, and BSA scoring 10% or more. Furthermore, they should be suitable for phototherapy or system therapy; total body weight has to exceed 50 kg (110 lb) while the BMI must fall within the range [18 - 35] kg/m^2 (inclusive)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis

2023. "A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06073119.

All > Psoriasis > Plaque Psoriasis