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Trial record 2 of 3 for:    ABC | SLE

A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02908100
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: GDC-0853
Drug: Placebo
Enrollment 260
Recruitment Details The study was conducted at 69 centers in 12 countries.
Pre-assignment Details An overall total of 616 participants were screened into the study, of which 356 participants were screen failures. 260 participants (Intent-To-Treat/ITT population) were randomized into the study, of which 1 participant did not receive any study treatment meaning that the Safety population consisted of 259 participants.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 86 87 87
Completed 63 66 66
Not Completed 23 21 21
Reason Not Completed
Adverse Event             7             6             9
Death             2             0             0
Lack of Efficacy             2             3             3
Lost to Follow-up             0             1             2
Non-Compliance With Study Drug             1             1             2
Non-Compliance With Contraceptive Method             1             0             0
Physician Decision             0             1             0
Pregnancy             1             2             0
Withdrawal by Subject             8             7             5
Randomised in Error             1             0             0
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID Total
Hide Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 86 87 87 260
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 87 participants 87 participants 260 participants
40.2  (11.5) 43.3  (12.4) 40.4  (10.6) 41.3  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 87 participants 87 participants 260 participants
Female
85
  98.8%
82
  94.3%
84
  96.6%
251
  96.5%
Male
1
   1.2%
5
   5.7%
3
   3.4%
9
   3.5%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 87 participants 87 participants 260 participants
Hispanic or Latino 54 61 61 176
Not Hispanic or Latino 32 25 26 83
Not Stated 0 1 0 1
[1]
Measure Description: Ethnicity
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 87 participants 87 participants 260 participants
American Indian or Alaska native 11 8 17 36
Asian 7 1 2 10
Black or African American 11 15 13 39
Multiple 1 1 3 5
White 56 62 52 170
[1]
Measure Description: Race
1.Primary Outcome
Title Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at 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 Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 86 87 87
Measure Type: Number
Unit of Measure: Percentage of Participants
44.2 50.6 51.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.373
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
- 8.5 to 21.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.339
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 7.5
Confidence Interval (2-Sided) 95%
-7.3 to 22.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title SRI-4 Response at Week 48 With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to Less Than (<)10 Milligrams Per Day (mg/Day) and Less Than or Equal to (</=) Day 1 Dose During Week 36 Through Week 48
Hide Description The 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. OCS tapering requires a sustained reduction of OCS from Week 36 through Week 48 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1].
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 86 87 87
Measure Type: Number
Unit of Measure: Percentage of Participants
41.9 50.6 44.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.223
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 8.7
Confidence Interval (2-Sided) 95%
-6.1 to 23.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.737
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-11.8 to 17.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title SRI-4 Response at Week 24 With a Sustained Reduction of OCS Dose to < 10 mg/Day and </= Day 1 Dose During Week 12 Through Week 24
Hide Description The 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. OCS tapering requires a sustained reduction of OCS from Week 12 through Week 24 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1].
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 86 87 87
Measure Type: Number
Unit of Measure: Percentage of Participants
43.0 47.1 47.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.614
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-10.7 to 18.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.607
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-10.7 to 18.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title SRI-4 Response at Week 24
Hide Description The 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 Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 86 87 87
Measure Type: Number
Unit of Measure: Percentage of Participants
46.5 52.9 52.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.410
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-8.5 to 21.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.418
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-8.5 to 21.2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels
Hide Description The 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. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug. Data presented below is only for participants that were included in the actual analysis.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 24 24 25
Measure Type: Number
Unit of Measure: Percentage of Participants
Plasmablast Signature Level Q1 Number Analyzed 24 participants 21 participants 20 participants
37.5 52.4 45.0
Plasmablast Signature Level Q2 Number Analyzed 22 participants 24 participants 19 participants
54.5 54.2 63.2
Plasmablast Signature Level Q3 Number Analyzed 19 participants 21 participants 25 participants
36.8 52.4 52.0
Plasmablast Signature Level Q4 Number Analyzed 20 participants 21 participants 23 participants
50.0 42.9 47.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Plasmablast Signature Level Q1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.378
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 14.9
Confidence Interval (2-Sided) 95%
-14 to 43.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Plasmablast Signature Level Q1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.732
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 7.5
Confidence Interval (2-Sided) 95%
-21.7 to 36.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Plasmablast Signature Level Q2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-29.2 to 28.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Plasmablast Signature Level Q2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 8.6
Confidence Interval (2-Sided) 95%
-21.4 to 38.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Plasmablast Signature Level Q3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.364
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 15.5
Confidence Interval (2-Sided) 95%
-14.9 to 46
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Plasmablast Signature Level Q3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 15.2
Confidence Interval (2-Sided) 95%
-14.1 to 44.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Plasmablast Signature Level Q4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.830
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value -7.1
Confidence Interval (2-Sided) 95%
-37.6 to 23.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Plasmablast Signature Level Q4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.963
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-32.1 to 27.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels
Hide Description The 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. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug. Data presented below is only for participants that were included in the actual analysis.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 24 24 25
Measure Type: Number
Unit of Measure: Percentage of Participants
Plasmablast Signature Level Q1 Number Analyzed 24 participants 21 participants 20 participants
33.3 52.4 40.0
Plasmablast Signature Level Q2 Number Analyzed 22 participants 24 participants 19 participants
54.5 54.2 57.9
Plasmablast Signature Level Q3 Number Analyzed 19 participants 21 participants 25 participants
36.8 52.4 44.0
Plasmablast Signature Level Q4 Number Analyzed 20 participants 21 participants 23 participants
45.0 42.9 39.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Plasmablast Signature Level Q1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.189
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 19.0
Confidence Interval (2-Sided) 95%
-9.4 to 47.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Plasmablast Signature Level Q1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.909
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
-21.9 to 35.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Plasmablast Signature Level Q2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-29.2 to 28.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Plasmablast Signature Level Q2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-27.1 to 33.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Plasmablast Signature Level Q3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.364
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 15.5
Confidence Interval (2-Sided) 95%
-14.9 to 46
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Plasmablast Signature Level Q3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.310
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 7.2
Confidence Interval (2-Sided) 95%
-22 to 36.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Plasmablast Signature Level Q4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.922
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-32.5 to 28.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Plasmablast Signature Level Q4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value -5.9
Confidence Interval (2-Sided) 95%
-35.4 to 23.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title SRI-6 Response at Week 24 and 48
Hide Description The Systemic Lupus Erythematosus Responder Index (SRI)-6 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 ≥6 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 Week 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 86 87 87
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 24 31.4 34.5 33.3
Week 48 27.9 39.1 35.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.692
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
-10.9 to 17.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-12 to 15.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 11.2
Confidence Interval (2-Sided) 95%
-2.8 to 25.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.286
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
-6.1 to 21.6
Estimation Comments [Not Specified]
8.Secondary Outcome
Title BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48
Hide Description The BICLA is a composite index that is defined as follows: [1] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (e.g., all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; [2] No new BILAG A or more than one new BILAG B scores; [3] No worsening of total SLEDAI-2K score from baseline; [4] No significant deterioration (=<10%) in physician's global assessment and [5] No treatment failure (initiation of non-protocol treatment).
Time Frame Week 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
The BICLA-evaluable population was defined as all all ITT participants who had at least one body system with moderate or severe disease activity at baseline as determined by BILAG-2004, i.e., at least one BILAG domain was scored as A or B at baseline.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 80 85 83
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 24 47.5 45.9 44.6
Week 48 41.2 52.9 42.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.936
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-16.8 to 13.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.683
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-18.2 to 12.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (150mg) QD
Comments Week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 11.7
Confidence Interval (2-Sided) 95%
-3.4 to 26.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GDC-0853 (200mg) BID
Comments Week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.879
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Difference
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-14.2 to 16.1
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description An Adverse Event 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 an abnormal laboratory finding, for example), 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 to 8 weeks after the last dose of study drug (up to Week 56).
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety-evaluable population was defined as all participants who received at least one dose of study medication. One participant in the Placebo arm was inadvertently dosed with GDC-0853 for a period of 27 days and was classified as part of the GDC-0853 (200mg) BID arm.
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 84 87 88
Measure Type: Number
Unit of Measure: Percentage of Participants
76.2 88.5 78.4
10.Secondary Outcome
Title Plasma Concentrations of Fenebrutinib at Specified Timepoints
Hide Description The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.
Time Frame Baseline (Pre-dose), Week 24 (Pre-dose and Post-dose) and Week 48 (Pre-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-evaluable population was defined as all participants who received at least one dose of fenebrutinib (GDC-0853) and had at least 1 evaluable post-dose PK sample. Data presented below is only for participants that were included in the actual analysis with detectable concentrations at the specified timepoints.
Arm/Group Title GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 87 86
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 0 (Pre-dose) Number Analyzed 87 participants 86 participants
NA [1]   (NA) NA [1]   (NA)
Week 24 (Pre-dose) Number Analyzed 67 participants 68 participants
41.9  (62.4) 180  (121)
Week 24 (2hr Post-dose) Number Analyzed 66 participants 67 participants
331  (226) 612  (353)
Week 24 (4-6hr Post-dose) Number Analyzed 65 participants 66 participants
215  (131) 414  (187)
Week 24 (8-10hr Post-dose) Number Analyzed 11 participants 7 participants
120  (111) 233  (145)
Week 48 (Pre-dose) Number Analyzed 64 participants 64 participants
25.5  (28.1) 137  (133)
[1]
No Drug was administered at this timepoint and so there were no detectable concentrations.
Time Frame Baseline up to 8 weeks after the last dose of study drug (up to Week 56).
Adverse Event Reporting Description The Safety Population was defined as all participants who received at least one dose of study medication. One participant in the Placebo arm was inadvertently dosed with GDC-0853 for a period of 27 days and was classified as part of the GDC-0853 (200mg) BID arm. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
 
Arm/Group Title Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/84 (2.38%)      1/87 (1.15%)      0/88 (0.00%)    
Hide Serious Adverse Events
Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/84 (10.71%)      4/87 (4.60%)      12/88 (13.64%)    
Blood and lymphatic system disorders       
LEUKOCYTOSIS  1  0/84 (0.00%)  0 1/87 (1.15%)  1 0/88 (0.00%)  0
THROMBOCYTOPENIA  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
Cardiac disorders       
CONGESTIVE CARDIOMYOPATHY  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
MYOCARDITIS  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
General disorders       
MULTIPLE ORGAN DYSFUNCTION SYNDROME  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
PYREXIA  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
Infections and infestations       
EPSTEIN-BARR VIRUS INFECTION  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
GASTROENTERITIS BACTERIAL  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
INFECTED SKIN ULCER  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
OSTEOMYELITIS CHRONIC  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
PNEUMONIA  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
PULMONARY TUBERCULOSIS  1  0/84 (0.00%)  0 1/87 (1.15%)  1 0/88 (0.00%)  0
PYELONEPHRITIS  1  1/84 (1.19%)  1 0/87 (0.00%)  0 1/88 (1.14%)  1
SEPTIC SHOCK  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
URINARY TRACT INFECTION  1  1/84 (1.19%)  1 0/87 (0.00%)  0 1/88 (1.14%)  1
Injury, poisoning and procedural complications       
ANKLE FRACTURE  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
Musculoskeletal and connective tissue disorders       
CHEST WALL HAEMATOMA  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
MUSCULAR WEAKNESS  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
PAIN IN EXTREMITY  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
SYSTEMIC LUPUS ERYTHEMATOSUS  1  2/84 (2.38%)  2 1/87 (1.15%)  1 2/88 (2.27%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
CERVIX CARCINOMA STAGE 0  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
SALIVARY GLAND NEOPLASM  1  0/84 (0.00%)  0 1/87 (1.15%)  1 0/88 (0.00%)  0
Nervous system disorders       
SYNCOPE  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
Pregnancy, puerperium and perinatal conditions       
ABORTION SPONTANEOUS  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
Psychiatric disorders       
DEPRESSION  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
Renal and urinary disorders       
RENAL COLIC  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
RENAL IMPAIRMENT  1  0/84 (0.00%)  0 0/87 (0.00%)  0 1/88 (1.14%)  1
Respiratory, thoracic and mediastinal disorders       
ACUTE RESPIRATORY FAILURE  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
PULMONARY OEDEMA  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
RESPIRATORY FAILURE  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
Skin and subcutaneous tissue disorders       
SKIN ULCER  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
Surgical and medical procedures       
ABORTION INDUCED  1  0/84 (0.00%)  0 1/87 (1.15%)  1 0/88 (0.00%)  0
Vascular disorders       
DEEP VEIN THROMBOSIS  1  1/84 (1.19%)  1 0/87 (0.00%)  0 0/88 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo GDC-0853 (150mg) QD GDC-0853 (200mg) BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/84 (50.00%)      54/87 (62.07%)      51/88 (57.95%)    
Blood and lymphatic system disorders       
LYMPHOPENIA  1  6/84 (7.14%)  6 2/87 (2.30%)  2 10/88 (11.36%)  12
NEUTROPENIA  1  4/84 (4.76%)  5 5/87 (5.75%)  5 6/88 (6.82%)  6
Gastrointestinal disorders       
ABDOMINAL PAIN UPPER  1  1/84 (1.19%)  1 2/87 (2.30%)  2 5/88 (5.68%)  7
DIARRHOEA  1  6/84 (7.14%)  6 5/87 (5.75%)  8 5/88 (5.68%)  6
NAUSEA  1  7/84 (8.33%)  7 4/87 (4.60%)  4 7/88 (7.95%)  7
Infections and infestations       
BRONCHITIS  1  6/84 (7.14%)  7 6/87 (6.90%)  6 7/88 (7.95%)  9
GASTROENTERITIS  1  5/84 (5.95%)  7 2/87 (2.30%)  2 2/88 (2.27%)  2
INFLUENZA  1  5/84 (5.95%)  8 5/87 (5.75%)  5 5/88 (5.68%)  5
NASOPHARYNGITIS  1  5/84 (5.95%)  6 8/87 (9.20%)  12 6/88 (6.82%)  6
SINUSITIS  1  3/84 (3.57%)  3 2/87 (2.30%)  2 5/88 (5.68%)  5
UPPER RESPIRATORY TRACT INFECTION  1  5/84 (5.95%)  7 9/87 (10.34%)  10 3/88 (3.41%)  3
URINARY TRACT INFECTION  1  9/84 (10.71%)  11 17/87 (19.54%)  21 11/88 (12.50%)  15
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  2/84 (2.38%)  4 1/87 (1.15%)  1 5/88 (5.68%)  6
BACK PAIN  1  2/84 (2.38%)  3 8/87 (9.20%)  9 4/88 (4.55%)  4
Nervous system disorders       
HEADACHE  1  9/84 (10.71%)  10 3/87 (3.45%)  4 3/88 (3.41%)  3
Skin and subcutaneous tissue disorders       
RASH  1  0/84 (0.00%)  0 3/87 (3.45%)  3 6/88 (6.82%)  8
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
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: NCT02908100    
Other Study ID Numbers: GA30044
2016-001039-11 ( EudraCT Number )
First Submitted: September 14, 2016
First Posted: September 20, 2016
Results First Submitted: May 22, 2020
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020