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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06073119
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sanofi
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Sciences and Operations
Principal Investigator Affiliation	Sanofi
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, Chile, Czechia, Georgia, Germany, Hungary, Japan, Mauritius, Poland, Portugal, Spain, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriasis

Additional Details

The overall study duration for each participant will be approximately up to 135 days.

Arms & Interventions

Arms

Experimental: SAR441566 dose regimen A

Participants will receive dose regimen A of SAR441566

Experimental: SAR441566 dose regimen B

Participants will receive dose regimen B of SAR441566

Experimental: SAR441566 dose regimen C

Participants will receive dose regimen C of SAR441566

Experimental: SAR441566 dose regimen D

Participants will receive dose regimen D of SAR441566

Experimental: SAR441566 dose regimen E

Participants will receive dose regimen E of SAR441566

Placebo Comparator: Placebo

Participants will receive SAR441566 matching placebo

Interventions

Drug: - SAR441566

Tablet

Drug: - Placebo

Tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Scottsdale, Arizona

Status

Recruiting

Address

Scottsdale Clinical Trials Site Number : 8400025

Scottsdale, Arizona, 85260

Site Contact

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