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.

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Full Description

The overall study duration for each participant will be approximately up to 135 days.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

207

Study ID:

NCT06073119

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 56 Locations for this study

See Locations Near You

Scottsdale Clinical Trials Site Number : 8400025
Scottsdale Arizona, 85260, United States
First OC Dermatology Site Number : 8400005
Fountain Valley California, 92708, United States
Center for Dermatology Clinical Research, Inc. Site Number : 8400003
Fremont California, 94538, United States
Dermatology Research Associates Site Number : 8400019
Los Angeles California, 90045, United States
Therapeutics Clinical Research Site Number : 8400006
San Diego California, 92123, United States
Daxia Trials Site Number : 8400022
Boca Raton Florida, 33431, United States
Renaissance Research and Medical Group, Inc Site Number : 8400018
Cape Coral Florida, 33991, United States
Driven Research, LLC Site Number : 8400012
Coral Gables Florida, 33134, United States
FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015
Fort Lauderdale Florida, 33308, United States
Direct Helpers Medical Center Inc Site Number : 8400023
Hialeah Florida, 33012, United States
FXM Clinical Research Miami, LLC Site Number : 8400016
Miami Florida, 33175, United States
Dawes Fretzin Clinical Research Group, LLC Site Number : 8400008
Indianapolis Indiana, 46256, United States
Center for Clinical Studies, LTD. LLP Site Number : 8400007
Houston Texas, 77004, United States
Center for Clinical Studies, LTD, LLP Site Number : 8400013
Webster Texas, 77598, United States
Jordan Valley Dermatology Center Site Number : 8400027
South Jordan Utah, 84095, United States
Investigational Site Number : 0320003
Caba Buenos Aires, C1023, Argentina
Investigational Site Number : 0320001
Buenos Aires Ciudad De Buenos Aires, 1060, Argentina
Investigational Site Number : 0320002
Caba Ciudad De Buenos Aires, C1425, Argentina
Investigational Site Number : 1240006
London Ontario, N6H 5, Canada
Investigational Site Number : 1240002
Waterloo Ontario, N2J 1, Canada
Investigational Site Number : 1520003
Santiago Reg Metropolitana De Santiago, 75802, Chile
Investigational Site Number : 1520001
Santiago Reg Metropolitana De Santiago, 76408, Chile
Investigational Site Number : 1520004
Santiago Reg Metropolitana De Santiago, 83300, Chile
Investigational Site Number : 1520002
Santiago Reg Metropolitana De Santiago, 84203, Chile
Investigational Site Number : 1560001
Hangzhou , 31000, China
Investigational Site Number : 2030003
Brno , 602 0, Czechia
Investigational Site Number : 2680002
Batumi , 6000, Georgia
Investigational Site Number : 2680001
Tbilisi , 0179, Georgia
Investigational Site Number : 2760003
Berlin , 10117, Germany
Investigational Site Number : 2760004
Blankenfelde-Mahlow , 15827, Germany
Investigational Site Number : 1000001
Dusseldorf , 40225, Germany
Investigational Site Number : 2760001
Frankfurt am Main , 60590, Germany
Investigational Site Number : 2760002
Witten , 58453, Germany
Investigational Site Number : 3480003
Budapest , 1083, Hungary
Investigational Site Number : 3480002
Debrecen , 4032, Hungary
Investigational Site Number : 3920001
Yokohama-Shi Kanagawa, 221-0, Japan
Investigational Site Number : 3920004
Kamimashiki Gun Kumamoto, 861-3, Japan
Investigational Site Number : 3920003
Sakai-shi Osaka, 593-8, Japan
Investigational Site Number : 3920006
Itabashi-ku Tokyo, 173-8, Japan
Investigational Site Number : 3920002
Tachikawa-shi Tokyo, 190-0, Japan
Investigational Site Number : 3920005
Ichikawa-shi , 272-0, Japan
Investigational Site Number : 4800001
Quatre Bornes , 72218, Mauritius
Investigational Site Number : 6160001
Bydgoszcz , 85-79, Poland
Investigational Site Number : 6160002
Katowice , 40-08, Poland
Investigational Site Number : 6200003
Guimarães , 4810-, Portugal
Investigational Site Number : 6200002
Lisboa , 1649-, Portugal
Investigational Site Number : 6200001
Lisboa , 1998-, Portugal
Investigational Site Number : 7240001
Barcelona Barcelona [Barcelona], 08041, Spain
Investigational Site Number : 7240003
Manises Valencia, 46940, Spain
Investigational Site Number : 7240007
Alicante , 03010, Spain
Investigational Site Number : 7240005
Madrid , 28040, Spain
Investigational Site Number : 7240004
Madrid , 28041, Spain
Investigational Site Number : 7240002
Zaragoza , 50009, Spain
Investigational Site Number : 7920002
Antalya , 07070, Turkey
Investigational Site Number : 7920001
Kayseri , 38039, Turkey
Investigational Site Number : 8260001
Manchester , M23 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

207

Study ID:

NCT06073119

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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