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

Korábbi kezelés

• 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
• Planned surgery during the treatment period
• Any live (attenuated) vaccine within 6 weeks prior to randomization (eg, varicella zoster vaccine, oral polio, rabies) or planned to receive one during the trial
  • The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial

Más betegség

• Any other skin diseases that could 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
• 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
• 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 have 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)
• 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

Laborértékek

• Participant with personal or family history of long QT syndrome

Egyéb

• Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, or pustular psoriasis. Nail psoriasis was accepted for inclusion.
• Plaque psoriasis was restricted to scalp, palms, soles, or flexures only.

• 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%
• Had to 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)