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

Description

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.

Study Start Date

January, 11 2018

Estimated Completion Date

April 2020

Interventions

  • Drug: GDC-0853

Study ID

Genentech, Inc. -- GA30066

Status

Unknown

Trial ID

NCT03407482

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

240

Sponsor

Genentech, Inc.

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

Gender

All

Ages

18 Years to 76 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (27)

Study Location Distance Name Phone Email
New England Research Associates - Trumbull, Connecticut 3.7 miles None None None
The Feinstein Institute for Medical Research The LitwinZucker Research Center - Manhasset, New York 41.8 miles None None None
New York University School of Medicine - New York, New York 50.2 miles None None None
Boston University Medical Center - Boston, Massachusetts 137.1 miles None None None
Saint Lawrence Health System - Canton, New York 252.1 miles None None None
Shanahan Rheumatology Immunology PLLC - Raleigh, North Carolina 476.9 miles None None None
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 482.1 miles None None None
Ohio State University Clinical Trials Management Office - Columbus, Ohio 520.3 miles None None None
Cincinnati Rheumatic Disease Study Group - Cincinnati, Ohio 613.2 miles None None None
University of Alabama at Birmingham - Birmingham, Alabama 916.1 miles None None None
Omega ResearchConsultants LLC - Orlando, Florida 989.4 miles None None None
Bay Area Arthritis and Osteoporosis - Brandon, Florida 1,054.9 miles None None None
Clinical Research of West Florida - Clearwater, Florida 1,063.7 miles None None None
RASFClinical Research Center - Boca Raton, Florida 1,102.6 miles None None None
University of Kansas Medical Center Research Institute Inc Phase 1 - Fairway, Kansas 1,139.7 miles None None None
Ochsner Clinic Foundation - Baton Rouge, Louisiana 1,246.5 miles None None None
Via Christi Research a division of Via Christi Hospitals Wichita Inc - Wichita, Kansas 1,303.5 miles None None None
Rheumatic Disease Clin Res Ctr - Houston, Texas 1,473.1 miles None None None
Tekton Research Inc - Austin, Texas 1,569.5 miles None None None
Arthritis Clinic Of Central Texas - San Marcos, Texas 1,589.8 miles None None None
Albuquerque Clinical Trials - Albuquerque, New Mexico 1,856.4 miles None None None
Institute of Arthritis Research - Idaho Falls, Idaho 1,972.8 miles None None None
University of Arizona Arthritis Center - Tucson, Arizona 2,164.2 miles None None None
HCP Clinical Research LLC - Huntington Beach, California 2,486.3 miles None None None
Valerius Medical Group - Los Alamitos, California 2,487.3 miles None None None
Wallace Rheumatic Study Center - Beverly Hills, California 2,495.9 miles None None None
UCLA David Geffen School of Medicine - Torrance, California 2,501.8 miles None None None

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