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

Last updated: January 22, 2025
Sponsor: Sanofi
Overall Status: Completed

Phase

2

Condition

Warts

Rash

Skin Wounds

Treatment

Placebo

SAR441566

Clinical Study ID

NCT06073119
DRI17849
2023-503911-14
2023-503911-14-00
U1111-1290-5787
  • Ages 18-75
  • All Genders

Study Summary

This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It is 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 include 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 will be 7.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • PASI ≥ 12 points;

  • and sPGA score ≥ 3 points;

  • and BSA score ≥ 10%

  • Must 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

Exclusion Criteria:

  • Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriaticarthritis, or pustular psoriasis. Nail psoriasis is accepted for inclusion.

  • Plaque psoriasis is restricted to scalp, palms, soles, or flexures only.

  • Any other skin diseases that can interfere with psoriasis evaluation or treatmentresponse (eg, atopic dermatitis, fungal or bacterial superinfection)

  • Other immunologic (autoimmune or inflammatory) disorder, except medically controlleddiabetes or thyroid disorder as per Investigator's judgement

  • History of recurrent or recent serious infection (eg, pneumonia, septicemia), orinfection(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, includinghistory of invasive opportunistic or helminthic infections despite infectionresolution or otherwise recurrent infections of abnormal frequency or prolongedduration

  • Participant with personal or family history of long QT syndrome

  • History of moderate to severe congestive heart failure (New York Heart AssociationClass III or IV), or recent cerebrovascular accident, or any other condition in theopinion of the Investigator that would put the participant at risk by participationin 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 lessthan 5 years, except adequately treated (cured) localized carcinoma in situ of thecervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of theskin

  • Any live (attenuated) vaccine within 6 weeks prior to randomization (eg, varicellazoster vaccine, oral polio, rabies) or plan to receive one during the trial

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Study Design

Total Participants: 221
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 26, 2023
Estimated Completion Date:
December 11, 2024

Study Description

The overall study duration for each participant will be approximately up to 149 days.

Connect with a study center

  • Investigational Site Number : 0320003

    Caba, Buenos Aires C1023AAB
    Argentina

    Site Not Available

  • Investigational Site Number : 0320001

    Buenos Aires, Ciudad De Buenos Aires 1060
    Argentina

    Site Not Available

  • Investigational Site Number : 0320002

    Caba, Ciudad De Buenos Aires C1425DKG
    Argentina

    Site Not Available

  • Investigational Site Number : 1000001

    Dusseldorf, 40225
    Bulgaria

    Active - Recruiting

  • Investigational Site Number : 1240006

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Investigational Site Number : 1240002

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana De Santiago 7640881
    Chile

    Site Not Available

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana De Santiago 8420383
    Chile

    Site Not Available

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana De Santiago 7580206
    Chile

    Site Not Available

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana De Santiago 8330034
    Chile

    Site Not Available

  • Investigational Site Number : 1560001

    Hangzhou, 310009
    China

    Site Not Available

  • Investigational Site Number : 1560002

    Wuxi, 610017
    China

    Site Not Available

  • Investigational Site Number : 2030003

    Brno, 602 00
    Czechia

    Site Not Available

  • Investigational Site Number : 2680002

    Batumi, 6000
    Georgia

    Site Not Available

  • Investigational Site Number : 2680001

    Tbilisi, 0179
    Georgia

    Site Not Available

  • Investigational Site Number : 2760003

    Berlin, 10117
    Germany

    Site Not Available

  • Investigational Site Number : 2760004

    Blankenfelde-Mahlow, 15827
    Germany

    Site Not Available

  • Investigational Site Number : 1000001

    Dusseldorf, 40225
    Germany

    Site Not Available

  • Investigational Site Number : 2760001

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Investigational Site Number : 2760002

    Witten, 58453
    Germany

    Site Not Available

  • Investigational Site Number : 3480003

    Budapest, 1083
    Hungary

    Site Not Available

  • Investigational Site Number : 3480002

    Debrecen, 4032
    Hungary

    Site Not Available

  • Investigational Site Number : 3920001

    Yokohama-Shi, Kanagawa 221-0825
    Japan

    Site Not Available

  • Investigational Site Number : 3920004

    Kamimashiki Gun, Kumamoto 861-3106
    Japan

    Site Not Available

  • Investigational Site Number : 3920003

    Sakai-shi, Osaka 593-8324
    Japan

    Site Not Available

  • Investigational Site Number : 3920006

    Itabashi-ku, Tokyo 173-8610
    Japan

    Site Not Available

  • Investigational Site Number : 3920002

    Tachikawa-shi, Tokyo 190-0023
    Japan

    Site Not Available

  • Investigational Site Number : 3920005

    Ichikawa-shi, 272-0033
    Japan

    Site Not Available

  • Investigational Site Number : 3920001

    Yokohama-shi, 221-0825
    Japan

    Site Not Available

  • Investigational Site Number : 4800001

    Quatre Bornes, 72218
    Mauritius

    Site Not Available

  • Investigational Site Number : 6160001

    Bydgoszcz, 85-796
    Poland

    Site Not Available

  • Investigational Site Number : 6160002

    Katowice, 40-081
    Poland

    Site Not Available

  • Investigational Site Number : 6200003

    Guimarães, 4810-061
    Portugal

    Site Not Available

  • Investigational Site Number : 6200001

    Lisboa, 1998-018
    Portugal

    Site Not Available

  • Investigational Site Number : 6200002

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona] 08041
    Spain

    Site Not Available

  • Investigational Site Number : 7240003

    Manises, Valencia 46940
    Spain

    Site Not Available

  • Investigational Site Number : 7240007

    Alicante, 03010
    Spain

    Site Not Available

  • Investigational Site Number : 7240004

    Madrid, 28041
    Spain

    Site Not Available

  • Investigational Site Number : 7240005

    Madrid, 28040
    Spain

    Site Not Available

  • Investigational Site Number : 7240002

    Zaragoza, 50009
    Spain

    Site Not Available

  • Investigational Site Number : 7920002

    Antalya, 07070
    Turkey

    Site Not Available

  • Investigational Site Number : 7920001

    Kayseri, 38039
    Turkey

    Site Not Available

  • Investigational Site Number : 8260001

    Manchester, M23 9QZ
    United Kingdom

    Site Not Available

  • Scottsdale Clinical Trials Site Number : 8400025

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • First OC Dermatology Site Number : 8400005

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Center for Dermatology Clinical Research, Inc. Site Number : 8400003

    Fremont, California 94538
    United States

    Site Not Available

  • Dermatology Research Associates Site Number : 8400019

    Los Angeles, California 90045
    United States

    Site Not Available

  • Dermatology Research Associates- Site Number : 8400019

    Los Angeles, California 90045
    United States

    Site Not Available

  • Therapeutics Clinical Research Site Number : 8400006

    San Diego, California 92123
    United States

    Site Not Available

  • Daxia Trials Site Number : 8400022

    Boca Raton, Florida 33431
    United States

    Site Not Available

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

    Cape Coral, Florida 33991
    United States

    Site Not Available

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

    Cape Coral, Florida 33991
    United States

    Site Not Available

  • Driven Research, LLC Site Number : 8400012

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Driven Research, LLC- Site Number : 8400012

    Coral Gables, Florida 33134
    United States

    Site Not Available

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

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Direct Helpers Medical Center Inc Site Number : 8400023

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Direct Helpers Medical Center Inc- Site Number : 8400023

    Hialeah, Florida 33012
    United States

    Site Not Available

  • FXM Clinical Research Miami, LLC Site Number : 8400016

    Miami, Florida 33175
    United States

    Site Not Available

  • FXM Clinical Research Miami, LLC- Site Number : 8400016

    Miami, Florida 33175
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC Site Number : 8400008

    Indianapolis, Indiana 46256
    United States

    Site Not Available

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

    Houston, Texas 77004
    United States

    Site Not Available

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

    Houston, Texas 77004
    United States

    Site Not Available

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

    Webster, Texas 77598
    United States

    Site Not Available

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

    Webster, Texas 77598
    United States

    Site Not Available

  • Jordan Valley Dermatology Center Site Number : 8400027

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Jordan Valley Dermatology Center- Site Number : 8400027

    South Jordan, Utah 84095
    United States

    Site Not Available

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