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

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT06073119

Run by

Sanofi

People needed

221

Starts

2023-10-26

Expected to finish

2024-12-11

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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…

• 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

Where it is running

• Dermatology Research Associates- Site Number : 8400019 — Los Angeles, California, United States
• Daxia Trials Site Number : 8400022 — Boca Raton, Florida, United States
• Renaissance Research and Medical Group, Inc- Site Number : 8400018 — Cape Coral, Florida, United States
• Driven Research, LLC- Site Number : 8400012 — Coral Gables, Florida, United States
• FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015 — Fort Lauderdale, Florida, United States
• Direct Helpers Medical Center Inc- Site Number : 8400023 — Hialeah, Florida, United States
• FXM Clinical Research Miami, LLC- Site Number : 8400016 — Miami, Florida, United States
• Center for Clinical Studies, LTD. LLP- Site Number : 8400007 — Houston, Texas, United States
• Center for Clinical Studies, LTD, LLP- Site Number : 8400013 — Webster, Texas, United States
• Jordan Valley Dermatology Center- Site Number : 8400027 — South Jordan, Utah, United States
• Investigational Site Number : 0320003 — CABA, Buenos Aires, Argentina
• Investigational Site Number : 0320001 — Buenos Aires, Buenos Aires F.D., Argentina
• Investigational Site Number : 0320002 — CABA, Buenos Aires F.D., Argentina
• Investigational Site Number : 1000001 — Sofia, Bulgaria
• Investigational Site Number : 1240006 — London, Ontario, Canada
• Investigational Site Number : 1240002 — Waterloo, Ontario, Canada
• Investigational Site Number : 1520003 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520001 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520004 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520002 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1560001 — Hangzhou, China
• Investigational Site Number : 1560002 — Wuxi, China
• Investigational Site Number : 2030003 — Brno, Czechia
• Investigational Site Number : 2680002 — Batumi, Georgia
• Scottsdale Clinical Trials Site Number : 8400025 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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