An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 76 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03407482
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Genentech, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Brazil, Bulgaria, Chile, Colombia, Germany, Korea, Republic of, Mexico, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Erythematosus, Systemic

Arms & Interventions

Arms

Experimental: GDC-0853

Participants will receive GDC-0853 twice daily (BID) for 48 weeks, followed by a safety follow-up period of 8 weeks.

Interventions

Drug: - GDC-0853

Participants will receive 4 tablets of GDC-0853 orally BID.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona Arthritis Center, Tucson, Arizona

Status

Withdrawn

Address

University of Arizona Arthritis Center

Tucson, Arizona, 85724

Site Contact

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