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

NCT06073119 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: DRI178492023-503911-14U1111-1290-57872023-503911-14-00
• Study Type: interventional
• Target: 221
• Locations: 17 countries
• Sites: 51

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a 75% or Greater Psoriasis Area and Severity Index (PASI) Score Reduction From Baseline (PASI75) at Week 12

  PASI is linear combination of percent of surface area of skin that is affected and severity of erythema(E),induration(i),desquamation(D) over 4 body regions: head(h),trunk(t),upper extremities(u),lower extremities(l). The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range:0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax":0=no involvement,1=\<10% to 6=90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. PASI score range:0 (no disease) to 72 (maximal disease);higher scores: greater psoriasis severity. Percentage of participants with PASI75 at Week 12 is presented.

  Baseline (Day 1) and Week 12

Secondary Outcomes (5)

• Percent Change From Baseline in Psoriasis Area and Severity Index to Week 12

  Baseline (Day 1) to Week 12

• Percentage of Participants With Static Psoriasis Global Assessment (sPGA) Score 0 (Complete Clearance) or 1 (Minimal Disease) at Week 12

  Baseline (Day 1) and Week 12

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Study Treatment Discontinuation and Study Withdrawals Due to TEAEs

  From first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days

• Pre-Dose Plasma Concentration of SAR441566

  1 hour pre-dose on Weeks 2, 4, 8 and 12

• Post-Dose Plasma Concentration of SAR441566

  2.5 to 3.5 hours post-dose on Day 1, Weeks 2, 4, 8 and 12

Study Arms (6)

SAR441566 dose regimen A

EXPERIMENTAL

Participants received dose regimen A of SAR441566

Drug: SAR441566

SAR441566 dose regimen B

EXPERIMENTAL

Participants received dose regimen B of SAR441566

Drug: SAR441566

SAR441566 dose regimen C

EXPERIMENTAL

Participants received dose regimen C of SAR441566

Drug: SAR441566

SAR441566 dose regimen D

EXPERIMENTAL

Participants received dose regimen D of SAR441566

Drug: SAR441566

SAR441566 dose regimen E

EXPERIMENTAL

Participants received dose regimen E of SAR441566

Drug: SAR441566

Placebo

PLACEBO COMPARATOR

Participants received SAR441566 matching placebo

Drug: Placebo

Interventions

SAR441566 DRUG

Tablet

SAR441566 dose regimen A; SAR441566 dose regimen B; SAR441566 dose regimen C; SAR441566 dose regimen D; SAR441566 dose regimen E

Placebo DRUG

Tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (51)

Scottsdale Clinical Trials Site Number : 8400025

Scottsdale, Arizona, 85260, United States

Location

Dermatology Research Associates- Site Number : 8400019

Los Angeles, California, 90045, United States

Location

Daxia Trials Site Number : 8400022

Boca Raton, Florida, 33431, United States

Location

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

Cape Coral, Florida, 33991, United States

Location

Driven Research, LLC- Site Number : 8400012

Coral Gables, Florida, 33134, United States

Location

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

Fort Lauderdale, Florida, 33308, United States

Location

Direct Helpers Medical Center Inc- Site Number : 8400023

Hialeah, Florida, 33012, United States

Location

FXM Clinical Research Miami, LLC- Site Number : 8400016

Miami, Florida, 33175, United States

Location

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

Houston, Texas, 77004, United States

Location

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

Webster, Texas, 77598, United States

Location

Jordan Valley Dermatology Center- Site Number : 8400027

South Jordan, Utah, 84095, United States

Location

Investigational Site Number : 0320003

CABA, Buenos Aires, C1023AAB, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, Buenos Aires F.D., 1060, Argentina

Location

Investigational Site Number : 0320002

CABA, Buenos Aires F.D., C1425DKG, Argentina

Location

Investigational Site Number : 1000001

Sofia, 1404, Bulgaria

Location

Investigational Site Number : 1240006

London, Ontario, N6H 5L5, Canada

Location

Investigational Site Number : 1240002

Waterloo, Ontario, N2J 1C4, Canada

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 8330034, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

Location

Investigational Site Number : 1560001

Hangzhou, 310009, China

Location

Investigational Site Number : 1560002

Wuxi, 610017, China

Location

Investigational Site Number : 2030003

Brno, 602 00, Czechia

Location

Investigational Site Number : 2680002

Batumi, 6000, Georgia

Location

Investigational Site Number : 2680001

Tbilisi, 0179, Georgia

Location

Investigational Site Number : 2760004

Blankenfelde-Mahlow, 15827, Germany

Location

Investigational Site Number : 2760001

Frankfurt am Main, 60590, Germany

Location

Investigational Site Number : 2760002

Witten, 58453, Germany

Location

Investigational Site Number : 3480003

Budapest, 1083, Hungary

Location

Investigational Site Number : 3480002

Debrecen, 4032, Hungary

Location

Investigational Site Number : 3920004

Kamimashiki Gun, Kumamoto, 861-3106, Japan

Location

Investigational Site Number : 3920003

Sakai-shi, Osaka, 593-8324, Japan

Location

Investigational Site Number : 3920006

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Investigational Site Number : 3920002

Tachikawa-shi, Tokyo, 190-0023, Japan

Location

Investigational Site Number : 3920005

Ichikawa-shi, 272-0033, Japan

Location

Investigational Site Number : 3920001

Yokohama, 221-0825, Japan

Location

Investigational Site Number : 4800001

Quatre Bornes, 72218, Mauritius

Location

Investigational Site Number : 6160001

Bydgoszcz, 85-796, Poland

Location

Investigational Site Number : 6160002

Katowice, 40-081, Poland

Location

Investigational Site Number : 6200003

Guimarães, 4810-061, Portugal

Location

Investigational Site Number : 6200002

Lisbon, 1649-035, Portugal

Location

Investigational Site Number : 6200001

Lisbon, 1998-018, Portugal

Location

Investigational Site Number : 7240003

Manises, Valencia, 46940, Spain

Location

Investigational Site Number : 7240007

Alicante, 03010, Spain

Location

Investigational Site Number : 7240005

Madrid, 28040, Spain

Location

Investigational Site Number : 7240004

Madrid, 28041, Spain

Location

Investigational Site Number : 7240002

Zaragoza, 50009, Spain

Location

Investigational Site Number : 7920002

Antalya, 07070, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Kayseri, 38039, Turkey (Türkiye)

Location

Investigational Site Number : 8260001

Manchester, M23 9QZ, United Kingdom

Location

Related Links

• DRI17849 Plain Language Results Summary

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610 ext 6#

Study Officials

• Clinical Sciences and Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: October 26, 2023
• Primary Completion: November 13, 2024
• Study Completion: December 11, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

PT (3); MA (1); PL (2); BU (1); US (11); JP (6); CA (2); DE (3); TU (2); GE (2); ES (5); GB (1); CN (2); CL (4); AR (3); CZ (1); HU (2)