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

NCT03407482 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: GA300662017-001764-37
• Study Type: interventional
• Target: 160
• Locations: 11 countries
• Sites: 53

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.

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48

  Baseline up to Week 48

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

GDC-0853 (200mg) BID

EXPERIMENTAL

Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).

Drug: GDC-0853

Interventions

GDC-0853 DRUG

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

GDC-0853 (200mg) BID

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (53)

Valerius Medical Group

Los Alamitos, California, 90720, United States

Location

RASF-Clinical Research Center

Boca Raton, Florida, 33486, United States

Location

Bay Area Arthritis and Osteoporosis

Brandon, Florida, 33511, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Institute of Arthritis Research

Idaho Falls, Idaho, 83404, United States

Location

Ochsner Clinic Foundation

Baton Rouge, Louisiana, 70809, United States

Location

Shanahan Rheumatology & Immunology, PLLC

Raleigh, North Carolina, 27617, United States

Location

Tekton Research Inc

Austin, Texas, 78745, United States

Location

Accurate Clinical Research

Houston, Texas, 77058-3675, United States

Location

Accurate Clinical Research

Houston, Texas, 77089, United States

Location

Arthritis Clinic Of Central Texas

San Marcos, Texas, 78666, United States

Location

APRILLUS

Buenos Aires, C1194AAO, Argentina

Location

Hospital Italiano de La Plata

La Plata, 1900, Argentina

Location

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, 5400, Argentina

Location

Centro Médico Privado de Reumatología

San Miguel de Tucumán, T4000AXL, Argentina

Location

CIP - Centro Internacional de Pesquisa

Goiânia, Goiás, 74110-120, Brazil

Location

Centro Mineiro de Pesquisa - CMIP

Juiz de Fora, Minas Gerais, 36036-330, Brazil

Location

Edumed - Educação e Saúde SA

Curitiba, Paraná, 80440-080, Brazil

Location

Centro de Pesquisas em Diabetes - CPD

Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

Location

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Faculdade de Medicina do ABC - FMABC

Santo André, São Paulo, 09060-650, Brazil

Location

Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*

Santo André, São Paulo, 09190-510, Brazil

Location

Centro de Pesquisas Clinicas; CPCLIN

São Paulo, São Paulo, 01228-200, Brazil

Location

Hospital Abreu Sodré - AACD

São Paulo, São Paulo, 04023-000, Brazil

Location

MHAT Plovdiv

Plovdiv, 4003, Bulgaria

Location

Medical Center "Teodora", EOOD

Rousse, 7000, Bulgaria

Location

Medical Center Excelsior OOD

Sofia, 1000, Bulgaria

Location

UMHAT "Sv. Ivan Rilski", EAD

Sofia, 1431, Bulgaria

Location

MC "Synexus - Sofia", EOOD

Sofia, 1784, Bulgaria

Location

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

Stara Zagora, 6000, Bulgaria

Location

CTR Estudios SPA

Providencia, 7500571, Chile

Location

Dermacross

Santiago, 66901, Chile

Location

Centro de Estudios Reumatologi

Santiago, 7501126, Chile

Location

Biomedica

Santiago, Chile

Location

Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

Barranquilla, 00000, Colombia

Location

Centro de Investigacion Medico Asistencial S.A.S

Barranquilla, 80020, Colombia

Location

Medicity S.A.S.

Bucaramanga, 680003, Colombia

Location

Servimed S.A.S.

Bucaramanga, 680003, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, 050034, Colombia

Location

Centro de Investigacion Alberto Bazzoni S.A. de C.V.

Torreón, Coahuila, 27000, Mexico

Location

Unidad de Atencion Medica e Investigacion en Salud S.C.

Mérida, Yucatán, 97000, Mexico

Location

Hospital Angeles Lindavista

México, 07760, Mexico

Location

Hospital Universitario de Saltillo

Saltillo, 25000, Mexico

Location

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosi S.l.p., 78240, Mexico

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Fundación Profesor Novoa Santos

A Coruña, LA Coruña, 15006, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Clinico Universitario Valladolid

Valladolid, 47005, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 00833, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Guy's Hospital; Louise Coote Lupus Unit

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

fenebrutinib

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The study was ended early due to the lack of efficacy seen in the parent study GA30044.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: January 9, 2018
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2019
• Last Updated: December 19, 2020
• Results First Posted: December 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (5); AR (4); ME (5); CL (4); US (11); GB (1); CO (5); BR (9); KR (1); TW (2); BU (6)