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

Lupus Erythematosus, Systemic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03407482
• Other study ID #: GA30066
• Secondary ID: 2017-001764-37
• Status: Terminated
• Phase: Phase 2
• Start date: January 9, 2018
• Est. completion date: November 20, 2019

Study information

• Verified date: November 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• GDC-0853
Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Chile,  Colombia,  Korea, Republic of,  Mexico,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs)	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.	Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)
Secondary	Systemic Lupus Erythematosus Responder-4 Index (SRI-4) 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.	Baseline up to Week 48
Secondary	Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State	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).	Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Secondary	Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)	Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).	Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Secondary	Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)	Population PK model estimated plasma decay half life of GDC-0853 at steady-state.	Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Secondary	Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)	Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.	Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)