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

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ClinicalTrials.gov Identifier: NCT03407482
Recruitment Status : Terminated (The study was ended early due to the lack of efficacy seen in the parent study GA30044.)
First Posted : January 23, 2018
Results First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Intervention Drug: GDC-0853
Enrollment 160
Recruitment Details The study was conducted at 50 centers in 11 countries.
Pre-assignment Details 160 participants were enrolled into this OLE study and were included in the ITT and Safety populations.
Arm/Group Title GDC-0853 (200mg) BID
Hide Arm/Group Description Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Period Title: Overall Study
Started 160
Completed 29
Not Completed 131
Reason Not Completed
Adverse Event             12
Disease Relapse             1
Lost to Follow-up             1
Non-Compliance With Study Drug             1
Pregnancy             2
Protocol Violation             1
Study Terminated By Sponsor             106
Withdrawal by Subject             6
Data Entry Error             1
Arm/Group Title GDC-0853 (200mg) BID
Hide Arm/Group Description Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Overall Number of Baseline Participants 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants
42.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
Female
155
  96.9%
Male
5
   3.1%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 160 participants
Hispanic or Latino 117
Not Hispanic or Latino 42
Not Stated 1
[1]
Measure Description: Ethnicity
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 160 participants
American Indian or Alaska native 24
Asian 5
Black or African American 22
Multiple 5
White 104
[1]
Measure Description: Race
1.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety-evaluable population was defined as all participants who received at least one dose of the study drug during this OLE study.
Arm/Group Title GDC-0853 (200mg) BID
Hide Arm/Group Description:
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of Participants
64.4
2.Secondary Outcome
Title Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title GDC-0853 (200mg) BID
Hide Arm/Group Description:
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GDC-0853 (200mg) BID
Hide Arm/Group Description:
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GDC-0853 (200mg) BID
Hide Arm/Group Description:
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GDC-0853 (200mg) BID
Hide Arm/Group Description:
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GDC-0853 (200mg) BID
Hide Arm/Group Description:
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GDC-0853 (200mg) BID
Hide Arm/Group Description Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
All-Cause Mortality
GDC-0853 (200mg) BID
Affected / at Risk (%)
Total   0/160 (0.00%)    
Hide Serious Adverse Events
GDC-0853 (200mg) BID
Affected / at Risk (%) # Events
Total   4/160 (2.50%)    
Infections and infestations   
CELLULITIS  1  1/160 (0.63%)  1
INFECTIVE TENOSYNOVITIS  1  1/160 (0.63%)  1
URINARY TRACT INFECTION  1  1/160 (0.63%)  1
Injury, poisoning and procedural complications   
LUMBAR VERTEBRAL FRACTURE  1  1/160 (0.63%)  1
Musculoskeletal and connective tissue disorders   
SYSTEMIC LUPUS ERYTHEMATOSUS  1  1/160 (0.63%)  1
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GDC-0853 (200mg) BID
Affected / at Risk (%) # Events
Total   31/160 (19.38%)    
Gastrointestinal disorders   
NAUSEA  1  9/160 (5.63%)  9
Infections and infestations   
NASOPHARYNGITIS  1  13/160 (8.13%)  14
URINARY TRACT INFECTION  1  15/160 (9.38%)  15
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
The study was ended early due to the lack of efficacy seen in the parent study GA30044.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03407482    
Other Study ID Numbers: GA30066
2017-001764-37 ( EudraCT Number )
First Submitted: January 15, 2018
First Posted: January 23, 2018
Results First Submitted: October 20, 2020
Results First Posted: December 19, 2020
Last Update Posted: December 19, 2020