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

Phase 2
Active, not recruiting
Conditions
Psoriasis
Interventions
Drug: Placebo
Drug: SAR441566
Registration Number
NCT06073119
Lead Sponsor
Sanofi
Brief 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.

Detailed Description

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

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
207
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%

  • 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)

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Exclusion Criteria

  • Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, 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 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 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 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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboParticipants will receive SAR441566 matching placebo
SAR441566 dose regimen BSAR441566Participants will receive dose regimen B of SAR441566
SAR441566 dose regimen ESAR441566Participants will receive dose regimen E of SAR441566
SAR441566 dose regimen ASAR441566Participants will receive dose regimen A of SAR441566
SAR441566 dose regimen CSAR441566Participants will receive dose regimen C of SAR441566
SAR441566 dose regimen DSAR441566Participants will receive dose regimen D of SAR441566
Primary Outcome Measures
NameTimeMethod
Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at week 12Baseline to Week 12

The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 (no disease) to 72 (maximal disease). It is a linear combination of percent of surface area of skin (A) that is affected (1 \[\<10%\] to 6 \[90% - 100%\]) and the severity of erythema \[E\], induration \[I\], and desquamation \[D\] on a scale from 0=no symptoms to 4=very marked over four body regions : head (h), trunk (t), upper extremities (u) and lower extremities (l).

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

Secondary Outcome Measures
NameTimeMethod
Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) at week 12Week 12

The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

Plasma pre-dose concentrations of SAR441566Week 2 to week 12
Plasma post-dose concentrations of SAR441566Week 0 to week 12
PASI percent change from baseline to week 12Baseline to week 12
Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)Baseline to week 16

Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs).

Trial Locations

Locations (54)

Scottsdale Clinical Trials Site Number : 8400025

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Scottsdale, Arizona, United States

First OC Dermatology Site Number : 8400005

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Fountain Valley, California, United States

Dermatology Research Associates Site Number : 8400019

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Los Angeles, California, United States

Daxia Trials Site Number : 8400022

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Boca Raton, Florida, United States

Renaissance Research and Medical Group, Inc Site Number : 8400018

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Cape Coral, Florida, United States

Driven Research, LLC Site Number : 8400012

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Coral Gables, Florida, United States

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

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Fort Lauderdale, Florida, United States

Direct Helpers Medical Center Inc Site Number : 8400023

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Hialeah, Florida, United States

FXM Clinical Research Miami, LLC Site Number : 8400016

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Miami, Florida, United States

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

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Houston, Texas, United States

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

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Webster, Texas, United States

Jordan Valley Dermatology Center Site Number : 8400027

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South Jordan, Utah, United States

Investigational Site Number : 0320003

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Caba, Buenos Aires, Argentina

Investigational Site Number : 0320001

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Buenos Aires, Ciudad De Buenos Aires, Argentina

Investigational Site Number : 0320002

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Caba, Ciudad De Buenos Aires, Argentina

Investigational Site Number : 1240006

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London, Ontario, Canada

Investigational Site Number : 1240002

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Waterloo, Ontario, Canada

Investigational Site Number : 1520003

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Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520001

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Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520004

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Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520002

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Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1560001

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Hangzhou, China

Investigational Site Number : 1560002

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Wuxi, China

Investigational Site Number : 2030003

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Brno, Czechia

Investigational Site Number : 2680002

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Batumi, Georgia

Investigational Site Number : 2680001

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Tbilisi, Georgia

Investigational Site Number : 2760003

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Berlin, Germany

Investigational Site Number : 2760004

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Blankenfelde-Mahlow, Germany

Investigational Site Number : 1000001

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Dusseldorf, Germany

Investigational Site Number : 2760001

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Frankfurt am Main, Germany

Investigational Site Number : 2760002

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Witten, Germany

Investigational Site Number : 3480003

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Budapest, Hungary

Investigational Site Number : 6200003

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Guimarães, Portugal

Investigational Site Number : 3480002

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Debrecen, Hungary

Investigational Site Number : 3920001

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Yokohama-Shi, Kanagawa, Japan

Investigational Site Number : 3920004

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Kamimashiki Gun, Kumamoto, Japan

Investigational Site Number : 3920003

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Sakai-shi, Osaka, Japan

Investigational Site Number : 3920006

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Itabashi-ku, Tokyo, Japan

Investigational Site Number : 3920002

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Tachikawa-shi, Tokyo, Japan

Investigational Site Number : 3920005

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Ichikawa-shi, Japan

Investigational Site Number : 4800001

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Quatre Bornes, Mauritius

Investigational Site Number : 6160001

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Bydgoszcz, Poland

Investigational Site Number : 6160002

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Katowice, Poland

Investigational Site Number : 6200002

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Lisboa, Portugal

Investigational Site Number : 6200001

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Lisboa, Portugal

Investigational Site Number : 7240001

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Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240005

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Madrid, Spain

Investigational Site Number : 7240004

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Madrid, Spain

Investigational Site Number : 7240003

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Manises, Valencia, Spain

Investigational Site Number : 7240007

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Alicante, Spain

Investigational Site Number : 7240002

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Zaragoza, Spain

Investigational Site Number : 7920002

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Antalya, Turkey

Investigational Site Number : 7920001

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Kayseri, Turkey

Investigational Site Number : 8260001

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Manchester, United Kingdom

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