Phase
Condition
Warts
Rash
Skin Wounds
Treatment
Placebo
SAR441566
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with moderate to severe plaque psoriasis for at least 6 months, meetingthe 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
Exclusion Criteria:
Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriaticarthritis, 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 treatmentresponse (eg, atopic dermatitis, fungal or bacterial superinfection)
Other immunologic (autoimmune or inflammatory) disorder, except medically controlleddiabetes or thyroid disorder as per Investigator's judgement
History of recurrent or recent serious infection (eg, pneumonia, septicemia), orinfection(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, includinghistory of invasive opportunistic or helminthic infections despite infectionresolution or otherwise recurrent infections of abnormal frequency or prolongedduration
Participant with personal or family history of long QT syndrome
History of moderate to severe congestive heart failure (New York Heart AssociationClass III or IV), or recent cerebrovascular accident, or any other condition in theopinion of the Investigator that would put the participant at risk by participationin 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 lessthan 5 years, except adequately treated (cured) localized carcinoma in situ of thecervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of theskin
Any live (attenuated) vaccine within 6 weeks prior to randomization (eg, varicellazoster 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 Design
Study Description
Connect with a study center
Investigational Site Number : 0320003
Caba, Buenos Aires C1023AAB
ArgentinaSite Not Available
Investigational Site Number : 0320001
Buenos Aires, Ciudad De Buenos Aires 1060
ArgentinaSite Not Available
Investigational Site Number : 0320002
Caba, Ciudad De Buenos Aires C1425DKG
ArgentinaSite Not Available
Investigational Site Number : 1000001
Dusseldorf, 40225
BulgariaActive - Recruiting
Investigational Site Number : 1240006
London, Ontario N6H 5L5
CanadaSite Not Available
Investigational Site Number : 1240002
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
Investigational Site Number : 1520001
Santiago, Reg Metropolitana De Santiago 7640881
ChileSite Not Available
Investigational Site Number : 1520002
Santiago, Reg Metropolitana De Santiago 8420383
ChileSite Not Available
Investigational Site Number : 1520003
Santiago, Reg Metropolitana De Santiago 7580206
ChileSite Not Available
Investigational Site Number : 1520004
Santiago, Reg Metropolitana De Santiago 8330034
ChileSite Not Available
Investigational Site Number : 1560001
Hangzhou, 310009
ChinaSite Not Available
Investigational Site Number : 1560002
Wuxi, 610017
ChinaSite Not Available
Investigational Site Number : 2030003
Brno, 602 00
CzechiaSite Not Available
Investigational Site Number : 2680002
Batumi, 6000
GeorgiaSite Not Available
Investigational Site Number : 2680001
Tbilisi, 0179
GeorgiaSite Not Available
Investigational Site Number : 2760003
Berlin, 10117
GermanySite Not Available
Investigational Site Number : 2760004
Blankenfelde-Mahlow, 15827
GermanySite Not Available
Investigational Site Number : 1000001
Dusseldorf, 40225
GermanySite Not Available
Investigational Site Number : 2760001
Frankfurt am Main, 60590
GermanySite Not Available
Investigational Site Number : 2760002
Witten, 58453
GermanySite Not Available
Investigational Site Number : 3480003
Budapest, 1083
HungarySite Not Available
Investigational Site Number : 3480002
Debrecen, 4032
HungarySite Not Available
Investigational Site Number : 3920001
Yokohama-Shi, Kanagawa 221-0825
JapanSite Not Available
Investigational Site Number : 3920004
Kamimashiki Gun, Kumamoto 861-3106
JapanSite Not Available
Investigational Site Number : 3920003
Sakai-shi, Osaka 593-8324
JapanSite Not Available
Investigational Site Number : 3920006
Itabashi-ku, Tokyo 173-8610
JapanSite Not Available
Investigational Site Number : 3920002
Tachikawa-shi, Tokyo 190-0023
JapanSite Not Available
Investigational Site Number : 3920005
Ichikawa-shi, 272-0033
JapanSite Not Available
Investigational Site Number : 3920001
Yokohama-shi, 221-0825
JapanSite Not Available
Investigational Site Number : 4800001
Quatre Bornes, 72218
MauritiusSite Not Available
Investigational Site Number : 6160001
Bydgoszcz, 85-796
PolandSite Not Available
Investigational Site Number : 6160002
Katowice, 40-081
PolandSite Not Available
Investigational Site Number : 6200003
Guimarães, 4810-061
PortugalSite Not Available
Investigational Site Number : 6200001
Lisboa, 1998-018
PortugalSite Not Available
Investigational Site Number : 6200002
Lisboa, 1649-035
PortugalSite Not Available
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona] 08041
SpainSite Not Available
Investigational Site Number : 7240003
Manises, Valencia 46940
SpainSite Not Available
Investigational Site Number : 7240007
Alicante, 03010
SpainSite Not Available
Investigational Site Number : 7240004
Madrid, 28041
SpainSite Not Available
Investigational Site Number : 7240005
Madrid, 28040
SpainSite Not Available
Investigational Site Number : 7240002
Zaragoza, 50009
SpainSite Not Available
Investigational Site Number : 7920002
Antalya, 07070
TurkeySite Not Available
Investigational Site Number : 7920001
Kayseri, 38039
TurkeySite Not Available
Investigational Site Number : 8260001
Manchester, M23 9QZ
United KingdomSite Not Available
Scottsdale Clinical Trials Site Number : 8400025
Scottsdale, Arizona 85260
United StatesSite Not Available
First OC Dermatology Site Number : 8400005
Fountain Valley, California 92708
United StatesSite Not Available
Center for Dermatology Clinical Research, Inc. Site Number : 8400003
Fremont, California 94538
United StatesSite Not Available
Dermatology Research Associates Site Number : 8400019
Los Angeles, California 90045
United StatesSite Not Available
Dermatology Research Associates- Site Number : 8400019
Los Angeles, California 90045
United StatesSite Not Available
Therapeutics Clinical Research Site Number : 8400006
San Diego, California 92123
United StatesSite Not Available
Daxia Trials Site Number : 8400022
Boca Raton, Florida 33431
United StatesSite Not Available
Renaissance Research and Medical Group, Inc Site Number : 8400018
Cape Coral, Florida 33991
United StatesSite Not Available
Renaissance Research and Medical Group, Inc- Site Number : 8400018
Cape Coral, Florida 33991
United StatesSite Not Available
Driven Research, LLC Site Number : 8400012
Coral Gables, Florida 33134
United StatesSite Not Available
Driven Research, LLC- Site Number : 8400012
Coral Gables, Florida 33134
United StatesSite Not Available
FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Direct Helpers Medical Center Inc Site Number : 8400023
Hialeah, Florida 33012
United StatesSite Not Available
Direct Helpers Medical Center Inc- Site Number : 8400023
Hialeah, Florida 33012
United StatesSite Not Available
FXM Clinical Research Miami, LLC Site Number : 8400016
Miami, Florida 33175
United StatesSite Not Available
FXM Clinical Research Miami, LLC- Site Number : 8400016
Miami, Florida 33175
United StatesSite Not Available
Dawes Fretzin Clinical Research Group, LLC Site Number : 8400008
Indianapolis, Indiana 46256
United StatesSite Not Available
Center for Clinical Studies, LTD. LLP Site Number : 8400007
Houston, Texas 77004
United StatesSite Not Available
Center for Clinical Studies, LTD. LLP- Site Number : 8400007
Houston, Texas 77004
United StatesSite Not Available
Center for Clinical Studies, LTD, LLP Site Number : 8400013
Webster, Texas 77598
United StatesSite Not Available
Center for Clinical Studies, LTD, LLP- Site Number : 8400013
Webster, Texas 77598
United StatesSite Not Available
Jordan Valley Dermatology Center Site Number : 8400027
South Jordan, Utah 84095
United StatesSite Not Available
Jordan Valley Dermatology Center- Site Number : 8400027
South Jordan, Utah 84095
United StatesSite Not Available
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