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)
Shanahan Rheumatology & Immunology, PLLC
🇺🇸Raleigh, North Carolina, United States
Centro Multidisciplinar de Estudos ClÃnicos - CEMEC*X*
🇧🇷Santo Andre, SP, Brazil
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Bay Area Arthritis and Osteoporosis
🇺🇸Brandon, Florida, United States
Valerius Medical Group
🇺🇸Los Alamitos, California, United States
Tekton Research Inc
🇺🇸Austin, Texas, United States
Accurate Clinical Research
🇺🇸Houston, Texas, United States
Institute of Arthritis Research
🇺🇸Idaho Falls, Idaho, United States
Hospital Italiano de La Plata
🇦🇷La Plata, Argentina
APRILLUS
🇦🇷Buenos Aires, Argentina
Centro Médico Privado de ReumatologÃa
🇦🇷San Miguel de Tucuman, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
🇦🇷San Juan, Argentina
Faculdade de Medicina do ABC - FMABC
🇧🇷Santo Andre, SP, Brazil
Edumed - Educação e Saúde SA
🇧🇷Curitiba, PR, Brazil
Centro de Pesquisas em Diabetes - CPD
🇧🇷Porto Alegre, RS, Brazil
Centro Mineiro de Pesquisa - CMIP
🇧🇷Juiz de Fora, MG, Brazil
Centro de Pesquisas Clinicas; CPCLIN
🇧🇷Sao Paulo, SP, Brazil
Medical Center Excelsior OOD
🇧🇬Sofia, Bulgaria
MHAT Plovdiv
🇧🇬Plovdiv, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
🇧🇬Sofia, Bulgaria
MC "Synexus - Sofia", EOOD
🇧🇬Sofia, Bulgaria
Hospital Universitario de Saltillo
🇲🇽Saltillo, Mexico
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario Rio Hortega
🇪🇸Valladolid, Spain
Guy's Hospital; Louise Coote Lupus Unit
🇬🇧London, United Kingdom
RASF-Clinical Research Center
🇺🇸Boca Raton, Florida, United States
Arthritis Clinic Of Central Texas
🇺🇸San Marcos, Texas, United States
CIP - Centro Internacional de Pesquisa
🇧🇷Goiania, GO, Brazil
Clinica de Neoplasias Litoral
🇧🇷Itajai, SC, Brazil
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
🇧🇬Stara Zagora, Bulgaria
Hospital Abreu Sodré - AACD
🇧🇷Sao Paulo, SP, Brazil
Dermacross
🇨🇱Santiago, Chile
Biomedica
🇨🇱Santiago, Chile
Hospital Pablo Tobon Uribe
🇨🇴Medellin, Colombia
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
🇲🇽Torreon, Coahuila, Mexico
Hospital Clinico Universitario Valladolid
🇪🇸Valladolid, Spain
Unidad de Atencion Medica e Investigacion en Salud S.C.
🇲🇽Mérida, Yucatan, Mexico
Fundación Profesor Novoa Santos
🇪🇸A Coruna, LA Coruña, Spain
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Medical Center "Teodora", EOOD
🇧🇬Ruse, Bulgaria
CTR Estudios SPA
🇨🇱Providencia, Chile
Servimed S.A.S.
🇨🇴Bucaramanga, Colombia
Hospital Angeles Lindavista
🇲🇽Mexico, Mexico
Hospital Central Dr. Ignacio Morones Prieto
🇲🇽San Luis Potosi S.l.p., Mexico
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Centro de Investigacion Medico Asistencial S.A.S
🇨🇴Barranquilla, Colombia
Medicity S.A.S.
🇨🇴Bucaramanga, Colombia
Centro de Estudios Reumatologi
🇨🇱Santiago, Chile
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
🇨🇴Barranquilla, Colombia
Ochsner Clinic Foundation
🇺🇸Baton Rouge, Louisiana, United States