An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Stopped early · Phase 2
Conditions studied: Lupus Erythematosus, Systemic
In brief
This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.
Key facts
- Study ID
- NCT03407482
- Run by
- Genentech, Inc.
- People needed
- 160
- Starts
- 2018-01-09
- Expected to finish
- 2019-11-20
- Last updated by the study team
- 2020-12-19
Who can join
Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able to comply with the study protocol, in the investigator's judgment
- Completion of Study GA30044 up to 48 weeks
- Acceptable safety and tolerability during Study GA30044 as determined by the investigator
You may not qualify if…
- Met protocol-defined treatment-stopping criteria during Study GA30044
- 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
Where it is running
- 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
- Valerius Medical Group — Los Alamitos, California, United States
Full record on ClinicalTrials.gov
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