An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
- Registration Number
- NCT03407482
- Lead Sponsor
- Genentech, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 160
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GDC-0853 (200mg) BID GDC-0853 Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks) An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) Population PK model estimated AUC of GDC-0853 From Time 0 to Time t (AUC0-t) at steady-state. AUC was measured in Nanograms (ng) per millilitre(mL)\*hour (hr).
Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48 Baseline up to Week 48 The Systemic Lupus Erythematosus Responder Index (SRI)-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss) Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).
Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss) Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) Population PK model estimated plasma decay half life of GDC-0853 at steady-state.
Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss) Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.
Trial Locations
- Locations (52)
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
Arthritis Clinic Of Central Texas
🇺🇸San Marcos, Texas, United States
Scroll for more (42 remaining)Valerius Medical Group🇺🇸Los Alamitos, California, United States