A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis

• Screening period: up to 4 weeks
• Treatment: 4 weeks (from Day 1 to Day 28)
• End-of-Study: between 7 to 13 days after the last IMP administration (from Day 35 to Day 41) Total study duration: 37 to 69 days maximum (approximately between 6 and 10 weeks)

Inclusion criteria

• Male or female with mild to moderate psoriatic participants, between 18 and 65 years of age, inclusive.
• Body mass index between 18.0 and 35.0 kg/m2, inclusive (body weight not under 50.0 Kg).
• Female participants who are only postmenopausal or are sterilized (e.g post-bilateral surgical oophorectomy not linked to a history of cancer) can be included in the study.
• Participant must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, vital signs, ECG, clinical laboratories, and urinalysis.
• Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months prior to screening with mild to moderate severity, defined as PASI ≤ 16.
• Participant must have at least two lesions with TLSS≥4 at both screening and baseline excluding the scalp.

Exclusion criteria

• Pre-existing signs of skin atrophy, telangiectasia or striae in the affected area
• Use of systemic immunosuppressants within 4 weeks of entering the study and during the entire study duration
• Current evidence of non-plaque forms of psoriasis (e.g., erythrodermic, guttate or pustular), psoriatic arthritis
• Currently evidence or suspicion of drug-induced psoriasis (e.g., new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Use of any of the following therapies within 4 weeks prior to Baseline (Day 1): systemic non-biologic psoriasis therapies (including, but not limited to): psoralens and ultraviolet A (PUVA) therapy, cyclosporine, methotrexate, azathioprine, corticosteroids, apremilast, tofacitinib, oral retinoids, mycophenolate mofetil, sirolimus; or phototherapy (including UVB or self-treatment with tanning beds or therapeutic sunbathing) or topical psoriasis therapy with psoralens
• Use of topical corticosteroid preparations (except hydrocortisone 1%), topical calcineurin inhibitors, or other topical preparations with immunomodulatory properties within 2 weeks prior to randomization (Day 1)
• Prior use of any biologicals for treatment of psoriasis
• Participants who received any live vaccination within 3 months, any initial non-live vaccination within 30 days or non-live booster vaccination within 14 days of first IMP administration or intend to receive any vaccination during the study.
• Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (including an ongoing biological proven SARS-CoV-2 infection and recurrent infection) or any condition that may affect participant safety in the judgment of the Investigator including participants who are not adequately vaccinated against a SARS-CoV-2 infection according to local regulations.
• Opportunistic infections within 6 months before randomization (Day 1)

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.