An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
NCT ID: NCT03407482
Last Updated: 2020-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
160 participants
INTERVENTIONAL
2018-01-09
2019-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GDC-0853 (200mg) BID
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
GDC-0853
Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GDC-0853
Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Completion of Study GA30044 up to 48 weeks
* Acceptable safety and tolerability during Study GA30044 as determined by the investigator
Exclusion Criteria
* An adverse event in Study GA30044 that required permanent discontinuation of study drug
* In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective
* Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor
18 Years
76 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Valerius Medical Group
Los Alamitos, California, United States
RASF-Clinical Research Center
Boca Raton, Florida, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, United States
Tekton Research Inc
Austin, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Arthritis Clinic Of Central Texas
San Marcos, Texas, United States
APRILLUS
Buenos Aires, , Argentina
Hospital Italiano de La Plata
La Plata, , Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, , Argentina
Centro Médico Privado de Reumatología
San Miguel de Tucumán, , Argentina
CIP - Centro Internacional de Pesquisa
Goiânia, Goiás, Brazil
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, Brazil
Edumed - Educação e Saúde SA
Curitiba, Paraná, Brazil
Centro de Pesquisas em Diabetes - CPD
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
Santo André, São Paulo, Brazil
Centro de Pesquisas Clinicas; CPCLIN
São Paulo, São Paulo, Brazil
Hospital Abreu Sodré - AACD
São Paulo, São Paulo, Brazil
MHAT Plovdiv
Plovdiv, , Bulgaria
Medical Center "Teodora", EOOD
Rousse, , Bulgaria
Medical Center Excelsior OOD
Sofia, , Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, , Bulgaria
MC "Synexus - Sofia", EOOD
Sofia, , Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, , Bulgaria
CTR Estudios SPA
Providencia, , Chile
Dermacross
Santiago, , Chile
Centro de Estudios Reumatologi
Santiago, , Chile
Biomedica
Santiago, , Chile
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Barranquilla, , Colombia
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, , Colombia
Medicity S.A.S.
Bucaramanga, , Colombia
Servimed S.A.S.
Bucaramanga, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
Torreón, Coahuila, Mexico
Unidad de Atencion Medica e Investigacion en Salud S.C.
Mérida, Yucatán, Mexico
Hospital Angeles Lindavista
México, , Mexico
Hospital Universitario de Saltillo
Saltillo, , Mexico
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosi S.l.p., , Mexico
Konkuk University Medical Center
Seoul, , South Korea
Fundación Profesor Novoa Santos
A Coruña, LA Coruña, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Clinico Universitario Valladolid
Valladolid, , Spain
Hospital Universitario Rio Hortega
Valladolid, , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Guy's Hospital; Louise Coote Lupus Unit
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-001764-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA30066
Identifier Type: -
Identifier Source: org_study_id