Back to resultsAn Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Primary Purpose
Lupus Erythematosus, Systemic
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GDC-0853
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic
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
Sites / Locations
- Valerius Medical Group
- RASF-Clinical Research Center
- Bay Area Arthritis and Osteoporosis
- Clinical Research of West Florida
- Institute of Arthritis Research
- Ochsner Clinic Foundation
- Shanahan Rheumatology & Immunology, PLLC
- Tekton Research Inc
- Accurate Clinical Research
- Accurate Clinical Research
- Arthritis Clinic Of Central Texas
- APRILLUS
- Hospital Italiano de La Plata
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
- Centro Médico Privado de Reumatología
- CIP - Centro Internacional de Pesquisa
- Centro Mineiro de Pesquisa - CMIP
- Edumed - Educação e Saúde SA
- Centro de Pesquisas em Diabetes - CPD
- Clinica de Neoplasias Litoral
- Faculdade de Medicina do ABC - FMABC
- Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
- Centro de Pesquisas Clinicas; CPCLIN
- Hospital Abreu Sodré - AACD
- MHAT Plovdiv
- Medical Center "Teodora", EOOD
- Medical Center Excelsior OOD
- UMHAT "Sv. Ivan Rilski", EAD
- MC "Synexus - Sofia", EOOD
- Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
- CTR Estudios SPA
- Dermacross
- Centro de Estudios Reumatologi
- Biomedica
- Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
- Centro de Investigacion Medico Asistencial S.A.S
- Medicity S.A.S.
- Servimed S.A.S.
- Hospital Pablo Tobon Uribe
- Konkuk University Medical Center
- Centro de Investigacion Alberto Bazzoni S.A. de C.V.
- Unidad de Atencion Medica e Investigacion en Salud S.C.
- Hospital Angeles Lindavista
- Hospital Universitario de Saltillo
- Hospital Central Dr. Ignacio Morones Prieto
- Fundación Profesor Novoa Santos
- Hospital Universitari Vall d'Hebron
- Hospital General Universitario Gregorio Marañon
- Hospital Clinico Universitario Valladolid
- Hospital Universitario Rio Hortega
- Kaohsiung Chang Gung Memorial Hospital
- National Taiwan University Hospital
- Guy's Hospital; Louise Coote Lupus Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GDC-0853 (200mg) BID
Arm Description
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03407482
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was ended early due to the lack of efficacy seen in the parent study GA30044.
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GDC-0853 (200mg) BID
Arm Type
Experimental
Arm Description
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Intervention Type
Drug
Intervention Name(s)
GDC-0853
Intervention Description
Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)
Secondary Outcome Measure Information:
Title
Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48
Description
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.
Time Frame
Baseline up to Week 48
Title
Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State
Description
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).
Time Frame
Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Title
Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)
Description
Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).
Time Frame
Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Title
Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)
Description
Population PK model estimated plasma decay half life of GDC-0853 at steady-state.
Time Frame
Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Title
Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)
Description
Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.
Time Frame
Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Valerius Medical Group
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
RASF-Clinical Research Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Bay Area Arthritis and Osteoporosis
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Ochsner Clinic Foundation
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Shanahan Rheumatology & Immunology, PLLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
Tekton Research Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77058-3675
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Arthritis Clinic Of Central Texas
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
APRILLUS
City
Buenos Aires
ZIP/Postal Code
C1194AAO
Country
Argentina
Facility Name
Hospital Italiano de La Plata
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Centro Médico Privado de Reumatología
City
San Miguel de Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
CIP - Centro Internacional de Pesquisa
City
Goiania
State/Province
GO
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Centro Mineiro de Pesquisa - CMIP
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36036-330
Country
Brazil
Facility Name
Edumed - Educação e Saúde SA
City
Curitiba
State/Province
PR
ZIP/Postal Code
80440-080
Country
Brazil
Facility Name
Centro de Pesquisas em Diabetes - CPD
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-170
Country
Brazil
Facility Name
Clinica de Neoplasias Litoral
City
Itajai
State/Province
SC
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Faculdade de Medicina do ABC - FMABC
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09190-510
Country
Brazil
Facility Name
Centro de Pesquisas Clinicas; CPCLIN
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Hospital Abreu Sodré - AACD
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-000
Country
Brazil
Facility Name
MHAT Plovdiv
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Medical Center "Teodora", EOOD
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Medical Center Excelsior OOD
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MC "Synexus - Sofia", EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
CTR Estudios SPA
City
Providencia
ZIP/Postal Code
7500571
Country
Chile
Facility Name
Dermacross
City
Santiago
ZIP/Postal Code
66901
Country
Chile
Facility Name
Centro de Estudios Reumatologi
City
Santiago
ZIP/Postal Code
7501126
Country
Chile
Facility Name
Biomedica
City
Santiago
Country
Chile
Facility Name
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
City
Barranquilla
ZIP/Postal Code
00000
Country
Colombia
Facility Name
Centro de Investigacion Medico Asistencial S.A.S
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Medicity S.A.S.
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Servimed S.A.S.
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Unidad de Atencion Medica e Investigacion en Salud S.C.
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Hospital Angeles Lindavista
City
Mexico
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Hospital Universitario de Saltillo
City
Saltillo
ZIP/Postal Code
25000
Country
Mexico
Facility Name
Hospital Central Dr. Ignacio Morones Prieto
City
San Luis Potosi S.l.p.
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Fundación Profesor Novoa Santos
City
A Coruna
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico Universitario Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
00833
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Guy's Hospital; Louise Coote Lupus Unit
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
Learn more about this trial
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
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