A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
NCT ID: NCT02908100
Last Updated: 2024-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2017-01-19
2019-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Placebo
Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.
GDC-0853 (150mg) QD
Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
GDC-0853
Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.
GDC-0853 (200mg) BID
Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
GDC-0853
Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.
Interventions
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GDC-0853
Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.
Placebo
Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer \>/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
* At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score \>/= 4.0 (at both screening and Day 1), Physician's Global Assessment \>/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
* If on oral corticosteroids (OCS), the dose must be \</= 40 mg/day prednisone (or equivalent)
* Stable doses of anti-malarial or immunosuppressive therapies
* Participants must be willing to avoid pregnancy
Exclusion Criteria
* Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
* History of having required hemodialysis or high dose corticosteroids (\>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
* Neuropsychiatric or central nervous system lupus manifestations
* Serum creatinine \> 2.5 mg/dL, or estimated glomerular-filtration rate \< 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
* History of receiving a solid organ transplant
* Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
* Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation
* History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
* Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
* Evidence of chronic and/or active hepatitis B or C
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Valerius Medical Group & Research Ctr of Greater Long Beach
Los Alamitos, California, United States
RASF-Clinical Research Center
Boca Raton, Florida, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States
Omega Research Consultants
Orlando, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States
The Arthritis & Diabetes Clinic, Inc.; Research
Monroe, Louisiana, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Saint Lawrence Health System
Canton, New York, United States
New York University School of Medicine
New York, New York, United States
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, United States
Ohio State University Clinical Trials Management Office
Columbus, Ohio, United States
Tekton Research Inc
Austin, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Arthritis Clinic Of Central Texas
San Marcos, Texas, United States
Organizacion Medica de Investigacion
Buenos Aires, , 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 Medico Privado de Reumatologia; Reumathology
San Miguel, , Argentina
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, Brazil
CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica
Goiânia, Goiás, Brazil
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, Brazil
CMiP - Centro Mineiro de Pesquisa*X*
Juiz de Fora, Minas Gerais, Brazil
Edumed - Educação e Saúde SA
Curitiba, Paraná, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas em Diabetes - CPD
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, Brazil
Hospital Estadual Mario Covas
Santo André, São Paulo, Brazil
Hospital Abreu Sodré - AACD
São Paulo, São Paulo, Brazil
MHAT Plovdiv
Plovdiv, , Bulgaria
Medical Center "Teodora", EOOD
Rousse, , Bulgaria
Medical Center Excelsior OOD
Sofia, , Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, , Bulgaria
MC "Synexus - Sofia", EOOD
Sofia, , Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, , Bulgaria
CTR Estudios SPA
Providencia, , Chile
Dermacross
Santiago, , Chile
Centro de Estudios Reumatológicos
Santiago, , Chile
SOMEAL
Santiago, , Chile
Biomedica
Santiago, , Chile
CEQUIN - Fundación Cardiomet Eje Cafetero
Armenia, , Colombia
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Barranquilla, , Colombia
Centro de Reumatologia y Ortopedia
Barranquilla, , Colombia
Medicity S.A.S.
Bucaramanga, , Colombia
Servimed S.A.S.
Bucaramanga, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Charite Research Organisation GmbH; Phase - I Unit of Hematology and Oncology
Berlin, , Germany
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
Torreón, Coahuila, Mexico
Unidad de Atencion Medica e Investigacion en Salud S.C.
Mérida, Yucatán, Mexico
Consultorio Particular del Dr. Miguel Cortes Hernandez
Cuernavaca, , Mexico
Hospital Angeles Lindavista
México, , Mexico
Hospital Universitario de Saltillo
Saltillo, , Mexico
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosí City, , Mexico
Konkuk University Medical Center
Seoul, , South Korea
The Catholic University of Korea St.Mary's Hospital
Seoul, , South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruña, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Clinico Universitario de Valladolid; Servicio de Reumatologia
Valladolid, , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan District, , Taiwan
University College London Hospital
London, , United Kingdom
Guy's Hospital; Louise Coote Lupus Unit
London, , United Kingdom
Countries
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References
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Isenberg D, Furie R, Jones NS, Guibord P, Galanter J, Lee C, McGregor A, Toth B, Rae J, Hwang O, Desai R, Lokku A, Ramamoorthi N, Hackney JA, Miranda P, de Souza VA, Jaller-Raad JJ, Maura Fernandes A, Garcia Salinas R, Chinn LW, Townsend MJ, Morimoto AM, Tuckwell K. Efficacy, Safety, and Pharmacodynamic Effects of the Bruton's Tyrosine Kinase Inhibitor Fenebrutinib (GDC-0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Oct;73(10):1835-1846. doi: 10.1002/art.41811. Epub 2021 Aug 24.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-001039-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA30044
Identifier Type: -
Identifier Source: org_study_id
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