Psoriasis Clinical Trial
A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis
Summary
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.
Full Description
The overall study duration for each participant will be approximately up to 135 days.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 49 Locations for this study
Scottsdale Arizona, 85260, United States
Fountain Valley California, 92708, United States
Fremont California, 94538, United States
Los Angeles California, 90045, United States
San Diego California, 92123, United States
Boca Raton Florida, 33431, United States
Cape Coral Florida, 33991, United States
Coral Gables Florida, 33134, United States
Fort Lauderdale Florida, 33308, United States
Hialeah Florida, 33012, United States
Miami Florida, 33175, United States
Indianapolis Indiana, 46250, United States
Houston Texas, 77004, United States
Webster Texas, 77598, United States
South Jordan Utah, 84095, United States
London Ontario, N6H 5, Canada
Waterloo Ontario, N2J 1, Canada
Santiago Reg Metropolitana De Santiago, 75802, Chile
Santiago Reg Metropolitana De Santiago, 76408, Chile
Santiago Reg Metropolitana De Santiago, 83300, Chile
Santiago Reg Metropolitana De Santiago, 84203, Chile
Brno , 602 0, Czechia
Batumi , 6000, Georgia
Tbilisi , 0179, Georgia
Berlin , 10117, Germany
Blankenfelde-Mahlow , 15827, Germany
Dusseldorf , 40225, Germany
Frankfurt am Main , 60590, Germany
Witten , 58453, Germany
Budapest , 1083, Hungary
Debrecen , 4032, Hungary
Yokohama-Shi Kanagawa, 221-0, Japan
Kamimashiki Gun Kumamoto, 861-3, Japan
Sakai-shi Osaka, 593-8, Japan
Tachikawa-shi Tokyo, 190-0, Japan
Ichikawa-shi , 272-0, Japan
Quatre Bornes , 72218, Mauritius
Bydgoszcz , 85-79, Poland
Katowice , 40-08, Poland
Lisboa , 1649-, Portugal
Lisboa , 1998-, Portugal
Barcelona Barcelona [Barcelona], 08041, Spain
Manises Valencia, 46940, Spain
Alicante , 03010, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Antalya , 07070, Turkey
Kayseri , 38039, Turkey
Manchester , M23 9, United Kingdom
How clear is this clinincal trial information?