Clinical trial NCT03407482: An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)
Secondary outcomes:
measure: Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48
timeFrame: Baseline up to Week 48
measure: Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State
timeFrame: Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
measure: Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)
timeFrame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
measure: Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)
timeFrame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
measure: Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)
timeFrame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Valerius Medical Group
state: California
city: Boca Raton
country: United States
facility: RASF-Clinical Research Center
state: Florida
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Raleigh
country: United States
facility: Shanahan Rheumatology & Immunology, PLLC
state: North Carolina
city: Austin
country: United States
facility: Tekton Research Inc
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: San Marcos
country: United States
facility: Arthritis Clinic Of Central Texas
state: Texas
city: Buenos Aires
country: Argentina
facility: APRILLUS
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
city: San Miguel de Tucuman
country: Argentina
facility: Centro Médico Privado de Reumatología
city: Goiania
country: Brazil
facility: CIP - Centro Internacional de Pesquisa
state: GO
city: Juiz de Fora
country: Brazil
facility: Centro Mineiro de Pesquisa - CMIP
state: MG
city: Curitiba
country: Brazil
facility: Edumed - Educação e Saúde SA
state: PR
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisas em Diabetes - CPD
state: RS
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: SC
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - FMABC
state: SP
city: Santo Andre
country: Brazil
facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
state: SP
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisas Clinicas; CPCLIN
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Abreu Sodré - AACD
state: SP
city: Plovdiv
country: Bulgaria
facility: MHAT Plovdiv
city: Ruse
country: Bulgaria
facility: Medical Center "Teodora", EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: MC "Synexus - Sofia", EOOD
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
city: Providencia
country: Chile
facility: CTR Estudios SPA
city: Santiago
country: Chile
facility: Dermacross
city: Santiago
country: Chile
facility: Centro de Estudios Reumatologi
city: Santiago
country: Chile
facility: Biomedica
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
city: Barranquilla
country: Colombia
facility: Centro de Investigacion Medico Asistencial S.A.S
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S.
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S.
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Torreon
country: Mexico
facility: Centro de Investigacion Alberto Bazzoni S.A. de C.V.
state: Coahuila
city: Mérida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud S.C.
state: Yucatan
city: Mexico
country: Mexico
facility: Hospital Angeles Lindavista
city: Saltillo
country: Mexico
facility: Hospital Universitario de Saltillo
city: San Luis Potosi S.l.p.
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
city: A Coruna
country: Spain
facility: Fundación Profesor Novoa Santos
state: LA Coruña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: London
country: United Kingdom
facility: Guy's Hospital; Louise Coote Lupus Unit
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: