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

NCT ID: NCT06073119

Last Updated: 2025-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2024-12-11

Brief Summary

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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.

Detailed Description

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The overall study duration for each participant was up to 149 days.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SAR441566 dose regimen A

Participants received dose regimen A of SAR441566

Group Type EXPERIMENTAL

SAR441566

Intervention Type DRUG

Tablet

SAR441566 dose regimen B

Participants received dose regimen B of SAR441566

Group Type EXPERIMENTAL

SAR441566

Intervention Type DRUG

Tablet

SAR441566 dose regimen C

Participants received dose regimen C of SAR441566

Group Type EXPERIMENTAL

SAR441566

Intervention Type DRUG

Tablet

SAR441566 dose regimen D

Participants received dose regimen D of SAR441566

Group Type EXPERIMENTAL

SAR441566

Intervention Type DRUG

Tablet

SAR441566 dose regimen E

Participants received dose regimen E of SAR441566

Group Type EXPERIMENTAL

SAR441566

Intervention Type DRUG

Tablet

Placebo

Participants received SAR441566 matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet

Interventions

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SAR441566

Tablet

Intervention Type DRUG

Placebo

Tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants with moderate to severe plaque psoriasis for at least 6 months, meeting the following criteria at screening and D1 (prior to randomization):

* PASI ≥ 12 points;
* and sPGA score ≥ 3 points;
* and BSA score ≥ 10%
* Had to be a candidate for phototherapy or systemic therapy.
* Total body weight ≥ 50 kg (110 lb) and body mass index (BMI) within the range \[18 - 35\] kg/m\^2 (inclusive)

Exclusion Criteria

* Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, or pustular psoriasis. Nail psoriasis was accepted for inclusion.
* Plaque psoriasis was restricted to scalp, palms, soles, or flexures only.
* Any other skin diseases that could interfere with psoriasis evaluation or treatment response (eg, atopic dermatitis, fungal or bacterial superinfection)
* Other immunologic (autoimmune or inflammatory) disorder, except medically controlled diabetes or thyroid disorder as per Investigator's judgement
* History of recurrent or recent serious infection (eg, pneumonia, septicemia), or infection(s) requiring hospitalization or treatment with IV antiinfectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1, or infections(s) requiring oral antiinfectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1
* Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
* Participant with personal or family history of long QT syndrome
* History of moderate to severe congestive heart failure (New York Heart Association Class III or IV), or recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would have put the participant at risk by participation in the protocol
* History of solid organ transplant
* History of alcohol or drug abuse within the past 2 years
* History of diagnosis of demyelinating disease such as but not limited to:

* Multiple Sclerosis
* Acute Disseminated Encephalomyelitis
* Balo's Disease (Concentric Sclerosis)
* Charcot-Marie-Tooth Disease
* Guillain-Barre Syndrome
* Human T-lymphotropic virus 1 Associated Myelopathy
* Neuromyelitis Optica (Devic's Disease)
* Planned surgery during the treatment period
* Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin
* Any live (attenuated) vaccine within 6 weeks prior to randomization (eg, varicella zoster vaccine, oral polio, rabies) or planned to receive one during the trial

The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences and Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Scottsdale Clinical Trials Site Number : 8400025

Scottsdale, Arizona, United States

Site Status

Dermatology Research Associates- Site Number : 8400019

Los Angeles, California, United States

Site Status

Daxia Trials Site Number : 8400022

Boca Raton, Florida, United States

Site Status

Renaissance Research and Medical Group, Inc- Site Number : 8400018

Cape Coral, Florida, United States

Site Status

Driven Research, LLC- Site Number : 8400012

Coral Gables, Florida, United States

Site Status

FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015

Fort Lauderdale, Florida, United States

Site Status

Direct Helpers Medical Center Inc- Site Number : 8400023

Hialeah, Florida, United States

Site Status

FXM Clinical Research Miami, LLC- Site Number : 8400016

Miami, Florida, United States

Site Status

Center for Clinical Studies, LTD. LLP- Site Number : 8400007

Houston, Texas, United States

Site Status

Center for Clinical Studies, LTD, LLP- Site Number : 8400013

Webster, Texas, United States

Site Status

Jordan Valley Dermatology Center- Site Number : 8400027

South Jordan, Utah, United States

Site Status

Investigational Site Number : 0320003

CABA, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320001

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Investigational Site Number : 0320002

CABA, Buenos Aires F.D., Argentina

Site Status

Investigational Site Number : 1000001

Sofia, , Bulgaria

Site Status

Investigational Site Number : 1240006

London, Ontario, Canada

Site Status

Investigational Site Number : 1240002

Waterloo, Ontario, Canada

Site Status

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1560001

Hangzhou, , China

Site Status

Investigational Site Number : 1560002

Wuxi, , China

Site Status

Investigational Site Number : 2030003

Brno, , Czechia

Site Status

Investigational Site Number : 2680002

Batumi, , Georgia

Site Status

Investigational Site Number : 2680001

Tbilisi, , Georgia

Site Status

Investigational Site Number : 2760004

Blankenfelde-Mahlow, , Germany

Site Status

Investigational Site Number : 2760001

Frankfurt am Main, , Germany

Site Status

Investigational Site Number : 2760002

Witten, , Germany

Site Status

Investigational Site Number : 3480003

Budapest, , Hungary

Site Status

Investigational Site Number : 3480002

Debrecen, , Hungary

Site Status

Investigational Site Number : 3920004

Kamimashiki Gun, Kumamoto, Japan

Site Status

Investigational Site Number : 3920003

Sakai-shi, Osaka, Japan

Site Status

Investigational Site Number : 3920006

Itabashi-ku, Tokyo, Japan

Site Status

Investigational Site Number : 3920002

Tachikawa-shi, Tokyo, Japan

Site Status

Investigational Site Number : 3920005

Ichikawa-shi, , Japan

Site Status

Investigational Site Number : 3920001

Yokohama, , Japan

Site Status

Investigational Site Number : 4800001

Quatre Bornes, , Mauritius

Site Status

Investigational Site Number : 6160001

Bydgoszcz, , Poland

Site Status

Investigational Site Number : 6160002

Katowice, , Poland

Site Status

Investigational Site Number : 6200003

Guimarães, , Portugal

Site Status

Investigational Site Number : 6200002

Lisbon, , Portugal

Site Status

Investigational Site Number : 6200001

Lisbon, , Portugal

Site Status

Investigational Site Number : 7240003

Manises, Valencia, Spain

Site Status

Investigational Site Number : 7240007

Alicante, , Spain

Site Status

Investigational Site Number : 7240005

Madrid, , Spain

Site Status

Investigational Site Number : 7240004

Madrid, , Spain

Site Status

Investigational Site Number : 7240002

Zaragoza, , Spain

Site Status

Investigational Site Number : 7920002

Antalya, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920001

Kayseri, , Turkey (Türkiye)

Site Status

Investigational Site Number : 8260001

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Bulgaria Canada Chile China Czechia Georgia Germany Hungary Japan Mauritius Poland Portugal Spain Turkey (Türkiye) United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://sanofi.trialsummaries.com/Study/StudyDetails?id=25536&tenant=MT_SNY_9011

DRI17849 Plain Language Results Summary

Other Identifiers

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2023-503911-14

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1290-5787

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-503911-14-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-503911-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRI17849

Identifier Type: -

Identifier Source: org_study_id