A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis
Investigating a Treatment Under Study for Moderate to Severe Plaque Psoriasis
Study Overview
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) (2 weeks ± 3 days). The total number of study visits will be 7.
Study Details
The overall study duration for each participant will be approximately up to 135 days.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Psoriasis
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Age: 18 years - 75 years
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Gender: All
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)
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
This study investigates an investigational treatment for adults with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. The purpose of this study is to find the right dose and to check the safety and effectiveness of the investigational treatment. Participants will be randomly assigned to different study arms, some of which will receive a placebo. A placebo is an inactive substance that looks like the investigational treatment but does not contain any medicine.
Participants will go through several procedures, including a screening period before starting the treatment. The treatment period will last for about 12 weeks, and it will be followed by a safety follow-up to monitor any side effects. Throughout the study, participants will have scheduled visits to the study site to assess their condition and response to the treatment.
- Who can participate: Adults with moderate to severe plaque psoriasis for at least 6 months may participate. Participants must weigh at least 50 kg and have a BMI between 18 and 35. They should be candidates for phototherapy or systemic therapy.
- Study details: Participants will be randomly assigned to receive either the investigational treatment or a placebo. They will attend study visits for assessments and monitoring. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
- Study Timelines and Visits: The study will last 135 days. The study requires 7 visits.