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A study of the long-term effects of fenebrutinib treatment in patients with lupus
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
- Autoimmune Disorder
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Terminated
This study runs in
Cities
- atlantico
- Austin
- Barcelona
- Barranquilla
- Baton Rouge
- Boca Raton
- Brandon
- Bucaramanga
- Buenos Aires
- Ciudad de México
- Clearwater
- dil
- Durham
- Goiás
- Houston
- Idaho Falls
- Kaohsiung City
- La Plata
- London
- Los Alamitos
- Madrid
- Medellín
- Minas Gerais
- Plovdiv
- Providencia
- Rio Grande do Sul
- Ruse
- San Luis Potosí
- San Marcos
- San Miguel de Tucumán
- Santa Catarina
- Santiago
- Seoul
- Sofia
- Stara Zagora
- São Paulo
- Taipei City
- Torreón
- Valladolid
- София
Trial Identifier:
NCT03407482 2017-001764-37 GA30066
Study Summary
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.
Genentech, Inc.
Sponsor
Phase 2
Phase
NCT03407482, GA30066, 2017-001764-37
Study Identifier
All
Gender
≥ 18 Years & ≤ 76 Years
Age
No
Healthy Volunteers
This clinical trial was done to study a new medicine called, “fenebrutinib”, for the treatment of patients with “lupus”. Researchers wanted to know if fenebrutinib was safe over a long-term period when given to patients with lupus. One hundred and sixty patients took part in this study at 49 study centers in 11 countries.
Study Summary
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.
Genentech, Inc.
Sponsor
Phase 2
Phase
NCT03407482, GA30066, 2017-001764-37
Trial Identifier
GDC-0853
Treatments
Lupus Erythematosus, Systemic
Condition
Official Title
A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
Eligibility Criteria
All
Gender
≥ 18 Years & ≤ 76 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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
Exclusion Criteria
- 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
For the latest version of this information please go to www.forpatients.roche.com