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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Sanofi
Study ID
NCT06073119
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SAR441566 — DRUG
    Tablet
  • Placebo — DRUG
    Tablet

Study Details

This was a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It was 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 included 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 was 7.

Key Dates

First listed
Oct 10, 2023
Start date
Oct 26, 2023
Status verified
Oct 2025
Primary completion
Nov 13, 2024
Completion
Dec 11, 2024

Study Design

Enrollment
221 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAR441566 dose regimen A
    Participants received dose regimen A of SAR441566
  • Experimental: SAR441566 dose regimen B
    Participants received dose regimen B of SAR441566
  • Experimental: SAR441566 dose regimen C
    Participants received dose regimen C of SAR441566
  • Experimental: SAR441566 dose regimen D
    Participants received dose regimen D of SAR441566
  • Experimental: SAR441566 dose regimen E
    Participants received dose regimen E of SAR441566
  • Placebo Comparator: Placebo
    Participants received SAR441566 matching placebo

Primary Outcome Measure

Percentage of Participants With a 75% or Greater Psoriasis Area and Severity Index (PASI) Score Reduction From Baseline (PASI75) at Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]

Locations (11)

FacilityCityStateZIPSite coordinators
Scottsdale Clinical Trials Site Number : 8400025ScottsdaleArizona85260-
Dermatology Research Associates- Site Number : 8400019Los AngelesCalifornia90045-
Daxia Trials Site Number : 8400022Boca RatonFlorida33431-
Renaissance Research and Medical Group, Inc- Site Number : 8400018Cape CoralFlorida33991-
Driven Research, LLC- Site Number : 8400012Coral GablesFlorida33134-
FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015Fort LauderdaleFlorida33308-
Direct Helpers Medical Center Inc- Site Number : 8400023HialeahFlorida33012-
FXM Clinical Research Miami, LLC- Site Number : 8400016MiamiFlorida33175-
Center for Clinical Studies, LTD. LLP- Site Number : 8400007HoustonTexas77004-
Center for Clinical Studies, LTD, LLP- Site Number : 8400013WebsterTexas77598-
Jordan Valley Dermatology Center- Site Number : 8400027South JordanUtah84095-

Find similar trials in Scottsdale, AZ

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Scottsdale Clinical Trials· Scottsdale, AZDermatology Research Associates· Los Angeles, CADaxia Trials· Boca Raton, FLRenaissance Research and Medical Group, Inc· Cape Coral, FLDriven Research, LLC· Coral Gables, FLFXM Clinical Research Ft. Lauderdale, LLC· Fort Lauderdale, FL

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