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A Study of Semorinemab in Patients With Moderate Alzheimer's Disease

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: NCT03828747
Recruitment Status : Active, not recruiting
First Posted : February 4, 2019
Results First Posted : October 3, 2022
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Semorinemab
Drug: Placebo
Drug: [18F]GTP1
Enrollment 272
Recruitment Details The study was conducted at 49 centers in 4 countries.
Pre-assignment Details A total of 272 participants were enrolled at 49 centers. 5 participants did not receive blinded treatment. These 267 participants represented the Safety Analysis population and data for this population is presented here.
Arm/Group Title Semorinemab Placebo
Hide Arm/Group Description Semorinemab will be administered intravenously in the double-blind treatment period and will be administered intravenously in the optional open-label extension period. Placebo was administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension.
Period Title: Double-Blind Treatment Period
Started 135 132
Cohort 1 [1] 78 86
Cohort 2 [2] 57 46
Completed 104 96
Not Completed 31 36
Reason Not Completed
Adverse Event             6             6
Death             1             2
Lost to Follow-up             0             1
Withdrawal by Subject             19             21
Physician Decision             0             3
Various reasons             5             3
[1]
Participants who completed the double-blind treatment period (before implementation of Protocol Version 3), or participants who completed the double-blind study drug treatment through Week 45 without any missed doses of study drug (after implementation of Protocol Version 4), were assigned to Cohort 1. In Cohort 1, the double-blind treatment period has a duration of 48 weeks.
[2]
Participants who were active in the double-blind treatment period (after implementation of Protocol Version 3) or participants who missed one or more study drug dose (after implementation of Protocol version 4) were assigned to Cohort 2. In Cohort 2, the double-blind treatment period has a duration of 60 weeks.
Period Title: Open-Label Extension
Started 104 95
Completed 0 0
Not Completed 104 95
Reason Not Completed
Continuing on Study             77             72
Adverse Event             3             4
Death             0             2
Lost to Follow-up             4             0
Withdrawal by Subject             19             16
Various reasons             1             1
Arm/Group Title Semorinemab Placebo Total
Hide Arm/Group Description Semorinemab will be administered intravenously in the double-blind treatment period and will be administered intravenously in the optional open-label extension period. Placebo was administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension. Total of all reporting groups
Overall Number of Baseline Participants 135 132 267
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants 132 participants 267 participants
71.6  (8.2) 73.1  (8.0) 72.3  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 132 participants 267 participants
Female
93
  68.9%
80
  60.6%
173
  64.8%
Male
42
  31.1%
52
  39.4%
94
  35.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 132 participants 267 participants
Hispanic or Latino
4
   3.0%
3
   2.3%
7
   2.6%
Not Hispanic or Latino
116
  85.9%
111
  84.1%
227
  85.0%
Unknown or Not Reported
15
  11.1%
18
  13.6%
33
  12.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 132 participants 267 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.7%
0
   0.0%
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   3.0%
5
   3.8%
9
   3.4%
White
121
  89.6%
115
  87.1%
236
  88.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
9
   6.7%
12
   9.1%
21
   7.9%
1.Primary Outcome
Title Change From Baseline to Last Visit of Double-Blind Treatment Period in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-Item Version (ADAS-Cog11)
Hide Description The Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-Item Version (ADAS-Cog11) is an 11 item cognitive subscale used to quantify the areas of cognitive function most often affected in Alzheimer's disease. The total score ranges from 0-70 with lower scores indicating better cognitive function.
Time Frame Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat population included all randomized participants who received at least one dose of study drug and had at least one baseline and one postbaseline ADAS-Cog11 score.
Arm/Group Title Semorinemab Placebo
Hide Arm/Group Description:
Semorinemab will be administered intravenously in the double-blind treatment period and will be administered intravenously in the optional open-label extension period.
Placebo was administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension.
Overall Number of Participants Analyzed 123 115
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Baseline Number Analyzed 123 participants 115 participants
23.93  (0.533) 24.09  (0.589)
Change from Baseline at Week 49 (includes Cohort 1 and 2) Number Analyzed 102 participants 96 participants
3.96  (0.658) 6.85  (0.643)
Change from Baseline at Week 61 (only Cohort 2) Number Analyzed 38 participants 30 participants
5.71  (0.907) 8.47  (0.965)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semorinemab, Placebo
Comments Change from Baseline at Week 49
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.89
Confidence Interval (2-Sided) 95%
-4.56 to -1.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.849
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semorinemab, Placebo
Comments Change from Baseline at Week 61
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0351
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.75
Confidence Interval (2-Sided) 95%
-5.31 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.287
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline to Last Visit of Double-Blind Treatment Period in Functional Capacities as Measured by the Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL)
Hide Description The Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL) is a scale used to quantify performance of activities of daily living (ADL). Scores on the ADCS-ADL range from 0-78, with higher scores indicating better ADL function.
Time Frame Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat population included all randomized participants who received at least one dose of study drug and had at least one baseline and one postbaseline ADAS-Cog11 and the ADCS-ADL score at the given time point.
Arm/Group Title Semorinemab Placebo
Hide Arm/Group Description:
Semorinemab will be administered intravenously in the double-blind treatment period and will be administered intravenously in the optional open-label extension period.
Placebo was administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension.
Overall Number of Participants Analyzed 123 115
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Baseline Number Analyzed 123 participants 115 participants
62.03  (0.764) 59.74  (0.842)
Change from Baseline at Week 49 (includes Cohort 1 and 2) Number Analyzed 107 participants 101 participants
-7.63  (1.002) -6.80  (0.974)
Change from Baseline at Week 61 (only Cohort 2) Number Analyzed 40 participants 33 participants
-9.29  (1.343) -7.57  (1.462)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semorinemab, Placebo
Comments Change from Baseline at Week 49
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5207
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.83
Confidence Interval 95%
-3.39 to 1.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.295
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semorinemab, Placebo
Comments Change from Baseline at Week 61
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3704
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.72
Confidence Interval 95%
-5.50 to 2.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.911
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Last Visit of Double-Blind Treatment Period on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Hide Description The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is a scale used to quantify the severity of symptoms of dementia. The CDR-SB is obtained through interviews of patients and informants, and disease severity is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18, with the higher values representing more severe impairment.
Time Frame Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat population included all randomized participants who received at least one dose of study drug and had at least one baseline and one postbaseline ADAS-Cog11 and the CDR-SB score at the given time point.
Arm/Group Title Semorinemab Placebo
Hide Arm/Group Description:
Semorinemab will be administered intravenously in the double-blind treatment period and will be administered intravenously in the optional open-label extension period.
Placebo was administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension.
Overall Number of Participants Analyzed 123 115
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Baseline Number Analyzed 123 participants 115 participants
6.23  (0.156) 6.51  (0.182)
Change from Baseline at Week 49 (includes Cohort 1 and 2) Number Analyzed 109 participants 101 participants
1.80  (0.217) 1.54  (0.214)
Change from Baseline at Week 61 (only Cohort 2) Number Analyzed 40 participants 33 participants
2.45  (0.367) 2.28  (0.393)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semorinemab, Placebo
Comments Change from Baseline at Week 49
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3501
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.26
Confidence Interval 95%
-0.29 to 0.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.282
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semorinemab, Placebo
Comments Change from Baseline at Week 61
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7431
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.87 to 1.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.525
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
Hide Description The Mini Mental State Examination (MMSE) is a brief clinical cognitive examination commonly used to screen for dementia and other cognitive deficits that has a total score of 0-30. Higher scores indicate better cognitive function.
Time Frame Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat population included all randomized participants who received at least one dose of study drug and had at least one baseline and one postbaseline ADAS-Cog11 and the MMSE score at the given time point.
Arm/Group Title Semorinemab Placebo
Hide Arm/Group Description:
Semorinemab will be administered intravenously in the double-blind treatment period and will be administered intravenously in the optional open-label extension period.
Placebo was administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension.
Overall Number of Participants Analyzed 123 115
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Baseline Number Analyzed 123 participants 115 participants
18.38  (0.182) 18.15  (0.197)
Change from Baseline at Week 49 (includes Cohort 1 and 2) Number Analyzed 105 participants 97 participants
-2.86  (0.330) -3.12  (0.325)
Change from Baseline at Week 61 (only Cohort 2) Number Analyzed 39 participants 29 participants
-3.14  (0.429) -4.22  (0.466)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semorinemab, Placebo
Comments Change from Baseline at Week 49
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5366
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.27
Confidence Interval 95%
-0.58 to 1.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.429
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semorinemab, Placebo
Comments Change from Baseline at Week 61
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0851
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.08
Confidence Interval 95%
-0.15 to 2.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.618
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An Adverse Event is any untoward medical occurrence in a subject 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 Clinical Cut Off Date (CCOD) of July 20, 2021 (approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
Arm/Group Title Semorinemab Placebo
Hide Arm/Group Description:
Semorinemab will be administered intravenously in the double-blind treatment period and will be administered intravenously in the optional open-label extension period.
Placebo was administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension.
Overall Number of Participants Analyzed 135 132
Measure Type: Count of Participants
Unit of Measure: Participants
113
  83.7%
107
  81.1%
6.Secondary Outcome
Title Serum Concentration of RO7105705 at Specified Timepoints
Hide Description [Not Specified]
Time Frame Weeks 1,3,5,9,13,25,37,49, and at treatment discontinuation (up to Week 48) for Cohort 1. Weeks 1,3,5,9,13,25,37,49,61, and at treatment discontinuation (up to Week 60) for Cohort 2.
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Incidence of Anti-drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
Hide Description [Not Specified]
Time Frame Weeks 1,13,25,37,49, and at treatment discontinuation (up to Week 48) for Cohort 1. Weeks 1,13,25,37,49,61, and at treatment discontinuation (up to Week 60) for Cohort 2.
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Relationship Between ADA Status and Percentage of Participants With Adverse Events
Hide Description Descriptive statistics will be used for assessment.
Time Frame Up to 57 weeks for Cohort 1, and up to 69 weeks for Cohort 2.
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Relationship Between ADA Status and Change From Baseline to Last Visit of Double-Blind Treatment Period in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-Item Version (ADAS-Cog11)
Hide Description

Descriptive statistics will be used for assessment.

A 70-point scale used to quantify the areas of cognitive function most often affected in Alzheimer's disease. Lower scores indicate better cognitive function.

Time Frame Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Relationship Between ADA Status and Change From Baseline to Last Visit of Double-Blind Treatment Period in Functional Capacities as Measured by the Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL)
Hide Description

Descriptive statistics will be used for assessment.

A scale used to quantify performance of activities of daily living. Scores on the ADCS-ADL range from 0-78, with higher scores indicating better ADL function.

Time Frame Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Relationship Between ADA Status and Change From Baseline to Last Visit of Double-Blind Treatment Period on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Hide Description

Descriptive statistics will be used for assessment.

A scale used to quantify the severity of symptoms of dementia. The CDR-SB is obtained through interviews of patients and informants, and disease severity is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The CDR-SOB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18, with the higher values representing more severe impairment.

Time Frame Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Relationship Between ADA Status and Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
Hide Description

Descriptive statistics will be used for assessment.

The Mini Mental State Examination (MMSE) is a brief clinical cognitive examination commonly used to screen for dementia and other cognitive deficits that has a total score of 0-30. Higher scores indicate better cognitive function.

Time Frame Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Relationship Between ADA Status and Serum Concentration of RO7105705 at Specified Timepoints
Hide Description Descriptive statistics will be used for assessment.
Time Frame Weeks 1,13,25,37,49, and at treatment discontinuation (up to Week 48) for Cohort 1. Weeks 1,13,25,37,49,61, and at treatment discontinuation (up to Week 60) for Cohort 2.
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Relationship Between ADA Status and Incidence of Anti-Drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
Hide Description Descriptive statistics will be used for assessment.
Time Frame Weeks 1,13,25,37,49, and at treatment discontinuation (up to Week 48) for Cohort 1. Weeks 1,13,25,37,49,61, and at treatment discontinuation (up to Week 60) for Cohort 2.
Outcome Measure Data Not Reported
Time Frame Baseline up to CCOD of July 20, 2021 (approximately 2.5 years)
Adverse Event Reporting Description The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
 
Arm/Group Title Semorinemab (Double Blind) Placebo Semorinemab (OLE)
Hide Arm/Group Description Semorinemab will be administered intravenously in the double-blind treatment period and will be administered intravenously in the optional open-label extension period. Placebo was administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension. Semorinemab will be administered intravenously in the double-blind treatment period and will be administered intravenously in the optional open-label extension period.
All-Cause Mortality
Semorinemab (Double Blind) Placebo Semorinemab (OLE)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/135 (0.74%)      4/132 (3.03%)      0/194 (0.00%)    
Hide Serious Adverse Events
Semorinemab (Double Blind) Placebo Semorinemab (OLE)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/135 (16.30%)      22/132 (16.67%)      14/194 (7.22%)    
Blood and lymphatic system disorders       
Leukocytosis  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Cardiac disorders       
Atrial fibrillation  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Bradycardia  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Cardiac failure  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Stress cardiomyopathy  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Arrhythmia  1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/194 (0.52%)  1
Sinus node dysfunction  1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/194 (0.52%)  1
Gastrointestinal disorders       
Abdominal pain  1  0/135 (0.00%)  0 2/132 (1.52%)  2 1/194 (0.52%)  1
Colitis  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Hernial eventration  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Inguinal hernia strangulated  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
General disorders       
Death  1  1/135 (0.74%)  1 1/132 (0.76%)  1 0/194 (0.00%)  0
Non-cardiac chest pain  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Cholecystitis  1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/194 (0.52%)  1
Chronic Exacerbated Cholecystitis on the Background of Urolithiasis  1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/194 (0.52%)  1
Infections and infestations       
COVID-19  1  1/135 (0.74%)  1 2/132 (1.52%)  2 1/194 (0.52%)  1
Cystitis  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Gastroenteritis  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Pneumonia  1  0/135 (0.00%)  0 2/132 (1.52%)  2 0/194 (0.00%)  0
Urinary tract infection  1  1/135 (0.74%)  1 0/132 (0.00%)  0 1/194 (0.52%)  1
Urosepsis  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
COVID-19 pneumonia  1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/194 (0.52%)  1
Injury, poisoning and procedural complications       
Craniocerebral injury  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Femoral neck fracture  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Head injury  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Hip fracture  1  0/135 (0.00%)  0 2/132 (1.52%)  2 0/194 (0.00%)  0
Joint dislocation  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Patella fracture  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Investigations       
SARS-CoV-2 test positive  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  1/135 (0.74%)  1 1/132 (0.76%)  1 0/194 (0.00%)  0
Diabetic metabolic decompensation  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma metastatic  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Invasive ductal breast carcinoma  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Ovarian cancer  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Renal neoplasm  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Squamous cell carcinoma  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Transitional cell carcinoma recurrent  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Bladder cancer recurrent  1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/194 (0.52%)  1
Nervous system disorders       
Cerebrovascular accident  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Dysarthria  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Seizure  1  1/135 (0.74%)  1 1/132 (0.76%)  1 0/194 (0.00%)  0
Subarachnoid haemorrhage  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Syncope  1  1/135 (0.74%)  1 1/132 (0.76%)  1 3/194 (1.55%)  3
Upper motor neurone lesion  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Psychiatric disorders       
Agitation  1  0/135 (0.00%)  0 3/132 (2.27%)  3 2/194 (1.03%)  2
Aggression  1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/194 (0.52%)  1
Renal and urinary disorders       
Hydronephrosis  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Nephrolithiasis  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Renal failure  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Vascular disorders       
Aortic aneurysm  1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/194 (0.00%)  0
Peripheral artery thrombosis  1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/194 (0.00%)  0
Hypotension  1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/194 (0.52%)  1
Peripheral artery aneurysm  1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/194 (0.52%)  1
1
Term from vocabulary, MedDRA 24.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Semorinemab (Double Blind) Placebo Semorinemab (OLE)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77/135 (57.04%)      71/132 (53.79%)      52/194 (26.80%)    
Gastrointestinal disorders       
Diarrhoea  1  7/135 (5.19%)  7 5/132 (3.79%)  6 2/194 (1.03%)  2
Infections and infestations       
Nasopharyngitis  1  9/135 (6.67%)  10 3/132 (2.27%)  3 0/194 (0.00%)  0
Urinary tract infection  1  10/135 (7.41%)  14 16/132 (12.12%)  19 10/194 (5.15%)  11
Injury, poisoning and procedural complications       
Fall  1  14/135 (10.37%)  19 19/132 (14.39%)  28 9/194 (4.64%)  16
Infusion related reaction  1  14/135 (10.37%)  30 5/132 (3.79%)  9 3/194 (1.55%)  3
Musculoskeletal and connective tissue disorders       
Arthralgia  1  7/135 (5.19%)  7 4/132 (3.03%)  4 7/194 (3.61%)  7
Nervous system disorders       
Dizziness  1  8/135 (5.93%)  8 9/132 (6.82%)  11 3/194 (1.55%)  4
Headache  1  11/135 (8.15%)  14 9/132 (6.82%)  10 2/194 (1.03%)  3
Psychiatric disorders       
Agitation  1  8/135 (5.93%)  8 5/132 (3.79%)  5 5/194 (2.58%)  5
Anxiety  1  9/135 (6.67%)  11 12/132 (9.09%)  12 4/194 (2.06%)  4
Depression  1  10/135 (7.41%)  10 6/132 (4.55%)  6 0/194 (0.00%)  0
Insomnia  1  7/135 (5.19%)  7 2/132 (1.52%)  2 4/194 (2.06%)  4
Vascular disorders       
Hypertension  1  8/135 (5.93%)  10 5/132 (3.79%)  5 3/194 (1.55%)  3
1
Term from vocabulary, MedDRA 24.1
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: NCT03828747    
Other Study ID Numbers: GN40040
First Submitted: January 29, 2019
First Posted: February 4, 2019
Results First Submitted: July 15, 2022
Results First Posted: October 3, 2022
Last Update Posted: October 3, 2022