Last updated 4 months ago

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

207 patients around the world

Available in Argentina, Chile

The overall study duration for each participant will be approximately up to 149 days.

Sanofi

2Research sites

207Patients around the world

This study is for people with

Psoriasis

Plaque psoriasis

Requirements for the patient

To 75 Years

All Gender

Medical requirements

: 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)

: 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

Sites

Psoriahue Medicina Interdisciplinaria - CABA, Buenos Aires

Recruiting

Bulnes 1937, CABA, Buenos Aires

Clínica Dermacross S.A. - Vitacura - Santiago

Recruiting

Av. Manquehue Norte 2051 C, Vitacura, Metropolitana, 7640881

StudySPECIFI-PSO

SponsorSanofi

Conditions

Plaque psoriasis

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06073119