Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study

Who is this study for? Patients with systemic lupus erythematosus
What treatments are being studied? SAR441344
Status: Recruiting
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18 to 70 years with active Systemic Lupus Erythematosus (SLE). Study details include: * Study duration: 36 weeks * Treatment duration: 24 weeks * Visit frequency: every 2 weeks

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria

• Positive antinuclear antibody (ANA) (titer ≥1:80) during screening

• Positivity for at least one serological characteristic

• Total hSELENA-SLEDAI score ≥6 (including points attributed from arthritis and rash) during screening and at least 4 points from clinical features at randomization as confirmed by a Sponsor-selected independent reviewer(s)

• At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s)

• Receiving at least one of the standard of care (SOC) for SLE (combination is possible)

• Body weight within 45 kg to 120 kg (inclusive) at screening

• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Locations
United States
Alabama
Accel Research Sites Network - Vestavia Hills- Site Number : 8400003
COMPLETED
Vestavia Hills
Arizona
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026
RECRUITING
Chandler
Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022
RECRUITING
Mesa
Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027
RECRUITING
Sun City
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023
RECRUITING
Tucson
California
Saint John's Physician Partners- Site Number : 8400015
RECRUITING
Santa Monica
Millennium Clinical Trials - Simi Valley- Site Number : 8400004
RECRUITING
Simi Valley
Florida
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002
RECRUITING
Debary
Innovia Research Center- Site Number : 8400037
RECRUITING
Miramar
Vitalia Medical Research - Margate- Site Number : 8400039
RECRUITING
Palm Beach
Integral Rheumatology and Immunology Specialists- Site Number : 8400014
RECRUITING
Plantation
Infigo Clinical Research- Site Number : 8400016
RECRUITING
Sanford
New Mexico
Inspire Santa Fe Medical Group- Site Number : 8400019
RECRUITING
Santa Fe
New York
Columbia University Irving Medical Center- Site Number : 8400009
RECRUITING
New York
Oklahoma
RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013
RECRUITING
Oklahoma City
Tennessee
Private Practice - Dr. Ramesh C. Gupta I- Site Number : 8400008
COMPLETED
Memphis
Texas
Tekton Research - West Gate- Site Number : 8400001
COMPLETED
Austin
Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017
RECRUITING
Colleyville
Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025
RECRUITING
Fort Worth
Prolato Clinical Research Center- Site Number : 8400005
RECRUITING
Houston
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving- Site Number : 8400024
RECRUITING
Irving
West Texas Clinical Research- Site Number : 8400018
RECRUITING
Lubbock
Other Locations
Argentina
Investigational Site Number : 0320008
COMPLETED
Berazategui
Investigational Site Number : 0320001
COMPLETED
Caba
Investigational Site Number : 0320002
COMPLETED
Caba
Investigational Site Number : 0320006
COMPLETED
Caba
Investigational Site Number : 0320004
COMPLETED
Ciudad Autonoma Bs As
Investigational Site Number : 0320003
COMPLETED
San Miguel De Tucumán
Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
COMPLETED
Curitiba
LMK Servicos Medicos- Site Number : 0760001
COMPLETED
Porto Alegre
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006
COMPLETED
São José Do Rio Preto
Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004
COMPLETED
São Paulo
IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760007
COMPLETED
São Paulo
Chile
Investigational Site Number : 1520002
COMPLETED
Osorno
Investigational Site Number : 1520001
COMPLETED
Santiago
Investigational Site Number : 1520004
COMPLETED
Santiago
Investigational Site Number : 1520003
COMPLETED
Talca
Georgia
Investigational Site Number : 2680001
RECRUITING
Tbilisi
Investigational Site Number : 2680002
RECRUITING
Tbilisi
Investigational Site Number : 2680003
RECRUITING
Tbilisi
Investigational Site Number : 2680004
RECRUITING
Tbilisi
Investigational Site Number : 2680005
RECRUITING
Tbilisi
Greece
Investigational Site Number : 3000001
RECRUITING
Athens
Investigational Site Number : 3000004
RECRUITING
Athens
Investigational Site Number : 3000003
RECRUITING
Heraklion
Investigational Site Number : 3000005
RECRUITING
Larissa
Investigational Site Number : 3000002
RECRUITING
Thessaloniki
Hungary
Investigational Site Number : 3480002
RECRUITING
Gyula
Investigational Site Number : 3480003
RECRUITING
Székesfehérvár
Italy
IRCCS Ospedale San Raffaele-Site Number : 3800001
RECRUITING
Milan
Investigational Site Number: 3800004
ACTIVE_NOT_RECRUITING
Naples
Fondazione Policlinico Universitario Agostino Gemelli-Site Number : 3800002
RECRUITING
Roma
Mauritius
Investigational Site Number : 4800001
COMPLETED
Quatre Bornes
Mexico
Investigational Site Number : 4840006
COMPLETED
Chihuahua City
Investigational Site Number : 4840011
COMPLETED
Chihuahua City
Investigational Site Number : 4840007
COMPLETED
México
Investigational Site Number : 4840004
COMPLETED
Mexico City
Investigational Site Number : 4840009
COMPLETED
Mexico City
Investigational Site Number : 4840001
COMPLETED
Monterrey
Investigational Site Number : 4840008
COMPLETED
Veracruz
Investigational Site Number : 4840005
COMPLETED
Yucatán
Puerto Rico
GCM Medical Group - San Juan - Calle Jose Marti- Site Number : 8400011
RECRUITING
San Juan
Russian Federation
Investigational Site Number : 6430002
COMPLETED
Moscow
Spain
Investigational Site Number : 7240001
RECRUITING
Madrid
Investigational Site Number : 7240002
RECRUITING
Sabadell
Investigational Site Number : 7240005
RECRUITING
Valencia
Investigational Site Number : 7240004
RECRUITING
Valladolid
Switzerland
Investigational Site Number : 7560001
RECRUITING
Sankt Gallen
Turkey
Investigational Site Number : 7920003
RECRUITING
Ankara
Investigational Site Number : 7920002
RECRUITING
Denizli
Ukraine
Investigational Site Number : 8040001
COMPLETED
Kyiv
Investigational Site Number : 8040006
COMPLETED
Kyiv
Investigational Site Number : 8040005
COMPLETED
Poltava
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2021-11-10
Estimated Completion Date: 2026-10-02
Participants
Target number of participants: 116
Treatments
Experimental: Frexalimab
Frexalimab intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks
Placebo_comparator: Placebo
Placebo IV loading dose followed by SC, 24 weeks
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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