A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis (SPECIFI-PSO)

A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Plaque Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: SAR441566

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1023AAB
      • Investigational Site Number : 0320003
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, 1060
      • Investigational Site Number : 0320001
    • CABA, Buenos Aires F.D., Argentina, C1425DKG
      • Investigational Site Number : 0320002
• Bulgaria
  • Sofia, Bulgaria, 1404
    • Investigational Site Number : 1000001
• Canada
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Investigational Site Number : 1240006
    • Waterloo, Ontario, Canada, N2J 1C4
      • Investigational Site Number : 1240002
• Chile
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
      • Investigational Site Number : 1520003
    • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
      • Investigational Site Number : 1520002
    • Santiago, Reg Metropolitana de Santiago, Chile, 8330034
      • Investigational Site Number : 1520004
• China
  • Hangzhou, China, 310009
    • Investigational Site Number : 1560001
  • Wuxi, China, 610017
    • Investigational Site Number : 1560002
• Czechia
  • Brno, Czechia, 602 00
    • Investigational Site Number : 2030003
• Georgia
  • Batumi, Georgia, 6000
    • Investigational Site Number : 2680002
  • Tbilisi, Georgia, 0179
    • Investigational Site Number : 2680001
• Germany
  • Blankenfelde-Mahlow, Germany, 15827
    • Investigational Site Number : 2760004
  • Frankfurt am Main, Germany, 60590
    • Investigational Site Number : 2760001
  • Witten, Germany, 58453
    • Investigational Site Number : 2760002
• Hungary
  • Budapest, Hungary, 1083
    • Investigational Site Number : 3480003
  • Debrecen, Hungary, 4032
    • Investigational Site Number : 3480002
• Japan
  • Ichikawa-shi, Japan, 272-0033
    • Investigational Site Number : 3920005
  • Yokohama, Japan, 221-0825
    • Investigational Site Number : 3920001
  • Kumamoto
    • Kamimashiki Gun, Kumamoto, Japan, 861-3106
      • Investigational Site Number : 3920004
  • Osaka
    • Sakai-shi, Osaka, Japan, 593-8324
      • Investigational Site Number : 3920003
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Investigational Site Number : 3920006
    • Tachikawa-shi, Tokyo, Japan, 190-0023
      • Investigational Site Number : 3920002
• Mauritius
  • Quatre Bornes, Mauritius, 72218
    • Investigational Site Number : 4800001
• Poland
  • Bydgoszcz, Poland, 85-796
    • Investigational Site Number : 6160001
  • Katowice, Poland, 40-081
    • Investigational Site Number : 6160002
• Portugal
  • Guimarães, Portugal, 4810-061
    • Investigational Site Number : 6200003
  • Lisbon, Portugal, 1998-018
    • Investigational Site Number : 6200001
  • Lisbon, Portugal, 1649-035
    • Investigational Site Number : 6200002
• Spain
  • Alicante, Spain, 03010
    • Investigational Site Number : 7240007
  • Madrid, Spain, 28041
    • Investigational Site Number : 7240004
  • Madrid, Spain, 28040
    • Investigational Site Number : 7240005
  • Zaragoza, Spain, 50009
    • Investigational Site Number : 7240002
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Investigational Site Number : 7240003
• Turkey (Türkiye)
  • Antalya, Turkey (Türkiye), 07070
    • Investigational Site Number : 7920002
  • Kayseri, Turkey (Türkiye), 38039
    • Investigational Site Number : 7920001
• United Kingdom
  • Manchester, United Kingdom, M23 9QZ
    • Investigational Site Number : 8260001
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Clinical Trials Site Number : 8400025
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates- Site Number : 8400019
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Daxia Trials Site Number : 8400022
    • Cape Coral, Florida, United States, 33991
      • Renaissance Research and Medical Group, Inc- Site Number : 8400018
    • Coral Gables, Florida, United States, 33134
      • Driven Research, LLC- Site Number : 8400012
    • Fort Lauderdale, Florida, United States, 33308
      • FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Medical Center Inc- Site Number : 8400023
    • Miami, Florida, United States, 33175
      • FXM Clinical Research Miami, LLC- Site Number : 8400016
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD. LLP- Site Number : 8400007
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies, LTD, LLP- Site Number : 8400013
  • Utah
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology Center- Site Number : 8400027

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAR441566 dose regimen A; Participants received dose regimen A of SAR441566	Drug: SAR441566; Tablet
Experimental: SAR441566 dose regimen B; Participants received dose regimen B of SAR441566	Drug: SAR441566; Tablet
Experimental: SAR441566 dose regimen C; Participants received dose regimen C of SAR441566	Drug: SAR441566; Tablet
Experimental: SAR441566 dose regimen D; Participants received dose regimen D of SAR441566	Drug: SAR441566; Tablet
Experimental: SAR441566 dose regimen E; Participants received dose regimen E of SAR441566	Drug: SAR441566; Tablet
Placebo Comparator: Placebo; Participants received SAR441566 matching placebo	Drug: Placebo; Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Psoriasis Area and Severity Index to Week 12	PASI is linear combination of percent of surface area of skin that is affected and severity of E, i, D over 4 body regions: h, t, u, 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. The PASI score ranges from 0 (no disease) to 72 (maximal disease); higher scores indicate greater psoriasis severity. Baseline was defined as last available value before the first dose of study treatment.	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	sPGA is 5-point score based on average thickness,erythema,and scaling of all psoriatic lesions.Score ranges:E:0(normal) to 4(bright to deep red coloration of lesions); i (plaque elevation):0(none) to 4(severe thickening with hard edges; D:0(no scaling) to 3(moderate scaling).Overall scoring: average of E,i,D;range:0(clear)= 0 for all 3 symptoms; 1(almost clear)=mean >0, <1.5, normal to pink coloration, just detectable(possible slight elevation),no to minimal focal scaling; 2(mild)= mean >= 1.5, <2.5, pink to light red coloration, mild thickening, predominantly fine scaling; 3(moderate)= mean >=2.5,<3.5, dull to bright red coloration, clearly distinguishable to moderate thickening, moderate scaling; 4(severe)= mean >=3.5,bright to deep dark red coloration,severe thickening with hard edges,severe coarse scaling covering almost all or all lesions.Lower score:less body coverage,with 0:complete clearance and 1:minimal disease. Total participants who received score of 0 and 1 are reported.	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	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were AEs that developed, worsened or became serious during the TE period. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.	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	Blood samples were collected at indicated timepoints for the assessment of pre-dose plasma concentration of SAR441566.	1 hour pre-dose on Weeks 2, 4, 8 and 12
Post-Dose Plasma Concentration of SAR441566	Blood samples were collected at indicated timepoints for the assessment of post-dose plasma concentration of SAR441566.	2.5 to 3.5 hours post-dose on Day 1, Weeks 2, 4, 8 and 12

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences and Operations, Sanofi

Publications and helpful links

Helpful Links

• DRI17849 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Actual): November 13, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: DRI17849; 2023-503911-14-00 (Registry Identifier: CTIS); U1111-1290-5787 (Registry Identifier: ICTRP); 2023-503911-14 (EudraCT Number: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No