A study to evaluate efficacy and safety of SAR441566 in adults with plaque psoriasis

Phase 1

• Conditions: Psoriasis; MedDRA version: 20.0Level: PTClassification code: 10037153Term: Psoriasis Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-503911-14-00
• Lead Sponsor: Sanofi-Aventis Research & Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-05
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 490

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%,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/m2 (inclusive).

Exclusion Criteria

Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, or pustular psoriasis. Nail psoriasis is accepted for inclusion., 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., 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 anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1, or infections(s) requiring oral anti-infectives (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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the superiority of SAR441566 over placebo in participants with moderate to severe plaque psoriasis, in the Naïve Targeted Immunotherapy Population (NTIP);Secondary Objective: To evaluate the efficacy of SAR441566 in plaque psoriasis as compared to placebo in the NTIP, To evaluate the safety of SAR441566, To assess pharmacokinetics of SAR441566 in participants with moderate to severe plaque psoriasis;Primary end point(s): Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):PASI percent change from baseline to week 12;Secondary end point(s):Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) at week 12;Secondary end point(s):Number of participants with Treatment- Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs);Secondary end point(s):Plasma pre-dose concentrations of SAR441566;Secondary end point(s):Plasma post-dose concentrations of SAR441566