Status:
COMPLETED
A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis
Lead Sponsor:
Sanofi
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This was a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It was designed to assess the therapeutic dose, efficacy, and safety of treat...
Detailed Description
The overall study duration for each participant was up to 149 days.
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
- 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
- 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 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)
- 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 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
Key Trial Info
Start Date :
October 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT06073119
Start Date
October 26 2023
End Date
December 11 2024
Last Update
November 10 2025
Active Locations (51)
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1
Scottsdale Clinical Trials Site Number : 8400025
Scottsdale, Arizona, United States, 85260
2
Dermatology Research Associates- Site Number : 8400019
Los Angeles, California, United States, 90045
3
Daxia Trials Site Number : 8400022
Boca Raton, Florida, United States, 33431
4
Renaissance Research and Medical Group, Inc- Site Number : 8400018
Cape Coral, Florida, United States, 33991