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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001764-37 | EudraCT Number |
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The study was ended early due to the lack of efficacy seen in the parent study GA30044.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDC-0853 (200mg) BID | Experimental | Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0853 | Drug | Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valerius Medical Group | Los Alamitos | California | 90720 | United States | ||
| RASF-Clinical Research Center |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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160 participants were enrolled into this OLE study and were included in the ITT and Safety populations.
The study was conducted at 50 centers in 11 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | GDC-0853 (200mg) BID | Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2017 |
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| 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 | 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) |
| 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) |
| 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) |
| 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) |
| Boca Raton |
| Florida |
| 33486 |
| United States |
| Bay Area Arthritis and Osteoporosis | Brandon | Florida | 33511 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | United States |
| Ochsner Clinic Foundation | Baton Rouge | Louisiana | 70809 | United States |
| Shanahan Rheumatology & Immunology, PLLC | Raleigh | North Carolina | 27617 | United States |
| Tekton Research Inc | Austin | Texas | 78745 | United States |
| Accurate Clinical Research | Houston | Texas | 77058-3675 | United States |
| Accurate Clinical Research | Houston | Texas | 77089 | United States |
| Arthritis Clinic Of Central Texas | San Marcos | Texas | 78666 | United States |
| APRILLUS | Buenos Aires | C1194AAO | Argentina |
| Hospital Italiano de La Plata | La Plata | 1900 | Argentina |
| CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica | San Juan | 5400 | Argentina |
| Centro Médico Privado de ReumatologÃa | San Miguel de Tucumán | T4000AXL | Argentina |
| CIP - Centro Internacional de Pesquisa | Goiânia | Goiás | 74110-120 | Brazil |
| Centro Mineiro de Pesquisa - CMIP | Juiz de Fora | Minas Gerais | 36036-330 | Brazil |
| Edumed - Educação e Saúde SA | Curitiba | Paraná | 80440-080 | Brazil |
| Centro de Pesquisas em Diabetes - CPD | Porto Alegre | Rio Grande do Sul | 90035-170 | Brazil |
| Clinica de Neoplasias Litoral | Itajaà | Santa Catarina | 88301-220 | Brazil |
| Faculdade de Medicina do ABC - FMABC | Santo André | São Paulo | 09060-650 | Brazil |
| Centro Multidisciplinar de Estudos ClÃnicos - CEMEC*X* | Santo André | São Paulo | 09190-510 | Brazil |
| Centro de Pesquisas Clinicas; CPCLIN | São Paulo | São Paulo | 01228-200 | Brazil |
| Hospital Abreu Sodré - AACD | São Paulo | São Paulo | 04023-000 | Brazil |
| MHAT Plovdiv | Plovdiv | 4003 | Bulgaria |
| Medical Center "Teodora", EOOD | Rousse | 7000 | Bulgaria |
| Medical Center Excelsior OOD | Sofia | 1000 | Bulgaria |
| UMHAT "Sv. Ivan Rilski", EAD | Sofia | 1431 | Bulgaria |
| MC "Synexus - Sofia", EOOD | Sofia | 1784 | Bulgaria |
| Medical Center "Nov Rehabilitatsionen Tsentar", EOOD | Stara Zagora | 6000 | Bulgaria |
| CTR Estudios SPA | Providencia | 7500571 | Chile |
| Dermacross | Santiago | 66901 | Chile |
| Centro de Estudios Reumatologi | Santiago | 7501126 | Chile |
| Biomedica | Santiago | Chile |
| Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS | Barranquilla | 00000 | Colombia |
| Centro de Investigacion Medico Asistencial S.A.S | Barranquilla | 80020 | Colombia |
| Medicity S.A.S. | Bucaramanga | 680003 | Colombia |
| Servimed S.A.S. | Bucaramanga | 680003 | Colombia |
| Hospital Pablo Tobon Uribe | MedellÃn | 050034 | Colombia |
| Centro de Investigacion Alberto Bazzoni S.A. de C.V. | Torreón | Coahuila | 27000 | Mexico |
| Unidad de Atencion Medica e Investigacion en Salud S.C. | Mérida | Yucatán | 97000 | Mexico |
| Hospital Angeles Lindavista | México | 07760 | Mexico |
| Hospital Universitario de Saltillo | Saltillo | 25000 | Mexico |
| Hospital Central Dr. Ignacio Morones Prieto | San Luis Potosi S.l.p. | 78240 | Mexico |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Fundación Profesor Novoa Santos | A Coruña | LA Coruña | 15006 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Clinico Universitario Valladolid | Valladolid | 47005 | Spain |
| Hospital Universitario Rio Hortega | Valladolid | 47012 | Spain |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 00833 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Guy's Hospital; Louise Coote Lupus Unit | London | SE1 9RT | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | GDC-0853 (200mg) BID | Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Ethnicity | Number | Participants |
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| Race/Ethnicity, Customized | Race | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The Safety-evaluable population was defined as all participants who received at least one dose of the study drug during this OLE study. | Posted | Number | Percentage of Participants | Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks) |
|
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| ||||||||||||||||||||||||||
| 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. | Please note that for this Outcome Measure, no data was collected at all due to no participants being evaluated at all, as a result of early termination of this study due to fenebrutinib not demonstrating improved efficacy compared to placebo across secondary or exploratory endpoints in the parent study (Study GA30044). | Posted | Baseline up to Week 48 |
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| 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). | Please note that for this Outcome Measure, incomplete PK data was collected as a result of early termination of the study which meant that data for the (AUC0-t,ss) parameter could not be generated via the Population PK model. | Posted | Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) |
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| 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). | Please note that for this Outcome Measure, incomplete PK data was collected as a result of early termination of the study which meant that data for the (Ctrough,ss) parameter could not be generated via the Population PK model. | Posted | Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) |
|
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| 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. | Please note that for this Outcome Measure, incomplete PK data was collected as a result of early termination of the study which meant that data for the (t1/2,ss) parameter could not be generated via the Population PK model. | Posted | Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) |
|
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| 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. | Please note that for this Outcome Measure, incomplete PK data was collected as a result of early termination of the study which meant that data for the (CL/F,ss) parameter could not be generated via the Population PK model. | Posted | Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) |
|
|
Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GDC-0853 (200mg) BID | Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID). | 0 | 160 | 4 | 160 | 31 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CELLULITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| INFECTIVE TENOSYNOVITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| SYSTEMIC LUPUS ERYTHEMATOSUS | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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The study was ended early due to the lack of efficacy seen in the parent study GA30044.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Oct 20, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000619415 | fenebrutinib |
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| Not Stated |
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| Black or African American |
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| Multiple |
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| White |
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