Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

PHASE2RecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

November 10, 2021

Primary Completion Date

July 10, 2026

Study Completion Date

October 2, 2026

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

SAR441344 IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

DRUG

SAR441344 SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

DRUG

Placebo IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

DRUG

Placebo SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

Trial Locations (73)

159

RECRUITING

Investigational Site Number : 2680003, Tbilisi

1430

COMPLETED

Investigational Site Number : 0320002, CABA

4000

COMPLETED

Investigational Site Number : 0320003, San Miguel de Tucumán

5700

RECRUITING

Investigational Site Number : 3480002, Gyula

8000

RECRUITING

Investigational Site Number : 3480003, Székesfehérvár

9007

RECRUITING

Investigational Site Number : 7560001, Sankt Gallen

11527

RECRUITING

Investigational Site Number : 3000004, Athens

11850

COMPLETED

Investigational Site Number : 4840007, México

12462

RECRUITING

Investigational Site Number : 3000001, Athens

20070

RECRUITING

Investigational Site Number : 7920002, Denizli

20132

RECRUITING

IRCCS Ospedale San Raffaele-Site Number : 3800001, Milan

28046

RECRUITING

Investigational Site Number : 7240001, Madrid

31020

COMPLETED

Investigational Site Number : 4840006, Chihuahua City

31203

COMPLETED

Investigational Site Number : 4840011, Chihuahua City

32713

RECRUITING

Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002, DeBary

32771

RECRUITING

Infigo Clinical Research- Site Number : 8400016, Sanford

33027

RECRUITING

Innovia Research Center- Site Number : 8400037, Miramar

33324

RECRUITING

Integral Rheumatology and Immunology Specialists- Site Number : 8400014, Plantation

33410

RECRUITING

Vitalia Medical Research - Margate- Site Number : 8400039, Palm Beach

35216

COMPLETED

Accel Research Sites Network - Vestavia Hills- Site Number : 8400003, Vestavia Hills

36011

COMPLETED

Investigational Site Number : 8040005, Poltava

38119

COMPLETED

Private Practice - Dr. Ramesh C. Gupta I- Site Number : 8400008, Memphis

41005

RECRUITING

Investigational Site Number : 3000005, Larissa

46014

RECRUITING

Investigational Site Number : 7240005, Valencia

47010

RECRUITING

Investigational Site Number : 7240004, Valladolid

64460

COMPLETED

Investigational Site Number : 4840001, Monterrey

71500

RECRUITING

Investigational Site Number : 3000003, Heraklion

72218

COMPLETED

Investigational Site Number : 4800001, Quatre Bornes

73116

RECRUITING

RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013, Oklahoma City

75039

RECRUITING

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving- Site Number : 8400024, Irving

76034

RECRUITING

Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017, Colleyville

76109

RECRUITING

Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025, Fort Worth

77054

RECRUITING

Prolato Clinical Research Center- Site Number : 8400005, Houston

78745

COMPLETED

Tekton Research - West Gate- Site Number : 8400001, Austin

79424

RECRUITING

West Texas Clinical Research- Site Number : 8400018, Lubbock

80138

ACTIVE_NOT_RECRUITING

Investigational Site Number: 3800004, Naples

85210

RECRUITING

Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022, Mesa

85225

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026, Chandler

85351

RECRUITING

Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027, Sun City

85748

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023, Tucson

87505

RECRUITING

Inspire Santa Fe Medical Group- Site Number : 8400019, Santa Fe

90404

RECRUITING

Saint John's Physician Partners- Site Number : 8400015, Santa Monica

91910

COMPLETED

Investigational Site Number : 4840008, Veracruz

93065

RECRUITING

Millennium Clinical Trials - Simi Valley- Site Number : 8400004, Simi Valley

97070

COMPLETED

Investigational Site Number : 4840005, Yucatán

111539

COMPLETED

Investigational Site Number : 6430002, Moscow

3465584

COMPLETED

Investigational Site Number : 1520003, Talca

5311092

COMPLETED

Investigational Site Number : 1520002, Osorno

7510047

COMPLETED

Investigational Site Number : 1520004, Santiago

7640881

COMPLETED

Investigational Site Number : 1520001, Santiago

10032-3725

RECRUITING

Columbia University Irving Medical Center- Site Number : 8400009, New York

CP 1884

COMPLETED

Investigational Site Number : 0320008, Berazategui

C1023AAB

COMPLETED

Investigational Site Number : 0320006, CABA

C1111

COMPLETED

Investigational Site Number : 0320001, CABA

C1121ABE

COMPLETED

Investigational Site Number : 0320004, Ciudad Autonoma Bs As

80060-240

COMPLETED

Centro de Estudos em Terapias Inovadoras- Site Number : 0760002, Curitiba

90480-000

COMPLETED

LMK Servicos Medicos- Site Number : 0760001, Porto Alegre

15090-000

COMPLETED

Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006, São José do Rio Preto

04014-002

COMPLETED

IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760007, São Paulo

04266-010

COMPLETED

Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004, São Paulo

0115

RECRUITING

Investigational Site Number : 2680004, Tbilisi

0131

RECRUITING

Investigational Site Number : 2680001, Tbilisi

0186

RECRUITING

Investigational Site Number : 2680002, Tbilisi

0190

RECRUITING

Investigational Site Number : 2680005, Tbilisi

546 36

RECRUITING

Investigational Site Number : 3000002, Thessaloniki

00168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli-Site Number : 3800002, Roma

03100

COMPLETED

Investigational Site Number : 4840009, Mexico City

06700

COMPLETED

Investigational Site Number : 4840004, Mexico City

00917

RECRUITING

GCM Medical Group - San Juan - Calle Jose Marti- Site Number : 8400011, San Juan

08208

RECRUITING

Investigational Site Number : 7240002, Sabadell

06800

RECRUITING

Investigational Site Number : 7920003, Ankara

02091

COMPLETED

Investigational Site Number : 8040006, Kyiv

02125

COMPLETED

Investigational Site Number : 8040001, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY