A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

PHASE2CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

January 19, 2017

Primary Completion Date

May 28, 2019

Study Completion Date

July 16, 2019

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

GDC-0853

Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.

DRUG

Placebo

Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.

Trial Locations (70)

333

Chang Gung Memorial Hospital - Linkou, Taoyuan District

1000

Medical Center Excelsior OOD, Sofia

1431

"UMHAT Sv. Ivan Rilski, EAD", Sofia

1784

"MC Synexus - Sofia, EOOD", Sofia

1900

Hospital Italiano de La Plata, La Plata

4003

MHAT Plovdiv, Plovdiv

5400

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica, San Juan

6000

"Medical Center Nov Rehabilitatsionen Tsentar, EOOD", Stara Zagora

7000

"Medical Center Teodora, EOOD", Rousse

10002

National Taiwan University Hospital, Taipei

10016

New York University School of Medicine, New York

12200

Charite Research Organisation GmbH; Phase - I Unit of Hematology and Oncology, Berlin

13617

Saint Lawrence Health System, Canton

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

25000

Hospital Universitario de Saltillo, Saltillo

27000

Centro de Investigacion Alberto Bazzoni S.A. de C.V., Torreón

27617

Shanahan Rheumatology & Immunology, PLLC, Raleigh

28007

Hospital General Universitario Gregorio Marañon, Madrid

32810

Omega Research Consultants, Orlando

33486

RASF-Clinical Research Center, Boca Raton

33511

Bay Area Arthritis and Osteoporosis, Brandon

33603

Clinical Research of West Florida, Tampa

35294

University of Alabama at Birmingham, Birmingham

43210

Ohio State University Clinical Trials Management Office, Columbus

47005

Hospital Clinico Universitario de Valladolid; Servicio de Reumatologia, Valladolid

62290

Consultorio Particular del Dr. Miguel Cortes Hernandez, Cuernavaca

66901

Dermacross, Santiago

67208

Via Christi Research, a division of Via Christi Hospitals Wichita, Inc., Wichita

70809

Ochsner Clinic Foundation, Baton Rouge

71203

The Arthritis & Diabetes Clinic, Inc.; Research, Monroe

77089

Accurate Clinical Research, Houston

78240

Hospital Central Dr Ignacio Morones Prieto, San Luis Potosí City

78666

Arthritis Clinic Of Central Texas, San Marcos

78745

Tekton Research Inc, Austin

80020

Centro de Reumatologia y Ortopedia, Barranquilla

83404

Institute of Arthritis Research, Idaho Falls

87102

Albuquerque Clinical Trials, Albuquerque

90720

Valerius Medical Group & Research Ctr of Greater Long Beach, Los Alamitos

97000

Unidad de Atencion Medica e Investigacion en Salud S.C., Mérida

680003

Medicity S.A.S., Bucaramanga

Servimed S.A.S., Bucaramanga

7500571

CTR Estudios SPA, Providencia

7501126

Centro de Estudios Reumatológicos, Santiago

7510186

SOMEAL, Santiago

77058-3675

Accurate Clinical Research, Houston

C1015ABO

Organizacion Medica de Investigacion, Buenos Aires

C1194AAO

APRILLUS, Buenos Aires

T4000AXL

Centro Medico Privado de Reumatologia; Reumathology, San Miguel

29055-450

CEDOES - Diagnóstico e Pesquisa, Vitória

74110-120

CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica, Goiânia

31270-901

Hospital das Clinicas - UFMG, Belo Horizonte

36010-570

CMiP - Centro Mineiro de Pesquisa*X*, Juiz de Fora

80440-080

Edumed - Educação e Saúde SA, Curitiba

90035-001

Hospital Moinhos de Vento, Porto Alegre

90035-170

Centro de Pesquisas em Diabetes - CPD, Porto Alegre

88301-220

Clinica de Neoplasias Litoral, Itajaí

09060-650

Faculdade de Medicina do ABC - FMABC, Santo André

09190-610

Hospital Estadual Mario Covas, Santo André

04023-000

Hospital Abreu Sodré - AACD, São Paulo

Unknown

Biomedica, Santiago

00000

CEQUIN - Fundación Cardiomet Eje Cafetero, Armenia

Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS, Barranquilla

050034

Hospital Pablo Tobon Uribe, Medellín

07760

Hospital Angeles Lindavista, México

05030

Konkuk University Medical Center, Seoul

150-713

The Catholic University of Korea St.Mary's Hospital, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

00833

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

NW1 - 2PG

University College London Hospital, London

SE1 9RT

Guy's Hospital; Louise Coote Lupus Unit, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY