Trial Outcomes & Findings for A Study of Semorinemab in Patients With Moderate Alzheimer's Disease (NCT NCT03828747)
NCT ID: NCT03828747
Last Updated: 2024-09-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
272 participants
Primary outcome timeframe
Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2
Results posted on
2024-09-24
Participant Flow
The study was conducted at 49 centers in 4 countries.
A total of 272 participants were enrolled at 49 centers.
Participant milestones
| Measure |
Semorinemab
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
|---|---|---|
|
Double-Blind Treatment Period
STARTED
|
136
|
136
|
|
Double-Blind Treatment Period
Cohort 1
|
92
|
99
|
|
Double-Blind Treatment Period
Cohort 2
|
43
|
33
|
|
Double-Blind Treatment Period
COMPLETED
|
106
|
102
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
30
|
34
|
|
Open-Label Extension
STARTED
|
102
|
97
|
|
Open-Label Extension
COMPLETED
|
48
|
52
|
|
Open-Label Extension
NOT COMPLETED
|
54
|
45
|
Reasons for withdrawal
| Measure |
Semorinemab
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
|---|---|---|
|
Double-Blind Treatment Period
Adverse Event
|
6
|
6
|
|
Double-Blind Treatment Period
Death
|
1
|
1
|
|
Double-Blind Treatment Period
Lost to Follow-up
|
0
|
1
|
|
Double-Blind Treatment Period
Withdrawal by Subject
|
17
|
19
|
|
Double-Blind Treatment Period
Physician Decision
|
1
|
4
|
|
Double-Blind Treatment Period
Various reasons
|
5
|
3
|
|
Open-Label Extension
Adverse Event
|
9
|
7
|
|
Open-Label Extension
Death
|
0
|
2
|
|
Open-Label Extension
Lost to Follow-up
|
4
|
0
|
|
Open-Label Extension
Withdrawal by Subject
|
31
|
30
|
|
Open-Label Extension
Various reasons
|
4
|
4
|
|
Open-Label Extension
Physician Decision
|
6
|
2
|
Baseline Characteristics
A Study of Semorinemab in Patients With Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Semorinemab
n=136 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=136 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 Years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
73.0 Years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
72.3 Years
STANDARD_DEVIATION 8.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
176 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
232 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
241 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2Population: 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.
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.
Outcome measures
| Measure |
Semorinemab
n=123 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=115 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
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)
Baseline
|
23.93 Units on a scale
Standard Error 0.533
|
24.09 Units on a scale
Standard Error 0.589
|
—
|
|
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)
Change from Baseline at Week 49 (includes Cohort 1 and 2)
|
3.96 Units on a scale
Standard Error 0.658
|
6.85 Units on a scale
Standard Error 0.643
|
—
|
|
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)
Change from Baseline at Week 61 (only Cohort 2)
|
5.71 Units on a scale
Standard Error 0.907
|
8.47 Units on a scale
Standard Error 0.965
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2Population: 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.
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.
Outcome measures
| Measure |
Semorinemab
n=123 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=115 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
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)
Baseline
|
62.03 Units on a scale
Standard Error 0.764
|
59.74 Units on a scale
Standard Error 0.842
|
—
|
|
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)
Change from Baseline at Week 49 (includes Cohort 1 and 2)
|
-7.63 Units on a scale
Standard Error 1.002
|
-6.80 Units on a scale
Standard Error 0.974
|
—
|
|
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)
Change from Baseline at Week 61 (only Cohort 2)
|
-9.29 Units on a scale
Standard Error 1.343
|
-7.57 Units on a scale
Standard Error 1.462
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2Population: 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.
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.
Outcome measures
| Measure |
Semorinemab
n=123 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=115 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Baseline
|
6.23 Units on a scale
Standard Error 0.156
|
6.51 Units on a scale
Standard Error 0.182
|
—
|
|
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Change from Baseline at Week 49 (includes Cohort 1 and 2)
|
1.80 Units on a scale
Standard Error 0.217
|
1.54 Units on a scale
Standard Error 0.214
|
—
|
|
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Change from Baseline at Week 61 (only Cohort 2)
|
2.45 Units on a scale
Standard Error 0.367
|
2.28 Units on a scale
Standard Error 0.393
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2Population: 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.
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.
Outcome measures
| Measure |
Semorinemab
n=123 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=115 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
Baseline
|
18.38 Units on a scale
Standard Error 0.182
|
18.15 Units on a scale
Standard Error 0.197
|
—
|
|
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
Change from Baseline at Week 49 (includes Cohort 1 and 2)
|
-2.86 Units on a scale
Standard Error 0.330
|
-3.12 Units on a scale
Standard Error 0.325
|
—
|
|
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
Change from Baseline at Week 61 (only Cohort 2)
|
-3.14 Units on a scale
Standard Error 0.429
|
-4.22 Units on a scale
Standard Error 0.466
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years and 7 months)Population: The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
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.
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=132 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
n=199 Participants
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
112 Participants
|
107 Participants
|
170 Participants
|
SECONDARY outcome
Timeframe: 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.Population: The pharmacokinetic(PK)-evaluable population included all safety-evaluable participants with at least 1 post-dose serum PK sample
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 1 predose
|
NA Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation NA
NA = not reportable as study drug hadn't been administered yet.
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 1 postdose
|
1610 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 27.9
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 3 predose
|
546 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 32.1
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 3 postdose
|
1980 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 32.6
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 5 predose
|
951 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 30.4
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 5 postdose
|
2260 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 47.0
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 9 predose
|
935 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 32.2
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 9 postdose
|
2520 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 27.2
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 13 predose
|
943 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 32.9
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 13 postdose
|
2480 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 31.2
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 25 predose
|
996 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 37.1
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 25 postdose
|
2420 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 37.9
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 37 predose
|
981 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 45.4
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 37 postdose
|
2430 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 31.1
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 49 predose
|
1020 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 35.2
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 49 postdose
|
2650 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 34.2
|
—
|
—
|
|
Serum Concentration of RO7105705 at Specified Timepoints
Week 61
|
1100 Microgram per milliliter (µg/ml)
Geometric Coefficient of Variation 26.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Participants with at least one predose and one postdose ADA assessment were included in this analysis.
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=132 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Incidence of Anti-drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
Baseline (BL) - positive sample
|
0 Participants
|
1 Participants
|
—
|
|
Incidence of Anti-drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
BL - negative sample
|
133 Participants
|
128 Participants
|
—
|
|
Incidence of Anti-drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
Post-BL - positive treatment emergent ADA
|
0 Participants
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
Post-BL - negative treatment emergent ADA
|
128 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 57 weeks for Cohort 1, and up to 69 weeks for Cohort 2.Population: Participants with at least one predose and one postdose ADA assessment were included in this analysis.
Descriptive statistics will be used for assessment.
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=132 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Relationship Between ADA Status and Percentage of Participants With Adverse Events
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2Population: Participants with at least one predose and one postdose ADA assessment were included in this analysis.
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.
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=132 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
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)
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2Population: Participants with at least one predose and one postdose ADA assessment were included in this analysis.
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.
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=132 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
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)
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2Population: Participants with at least one predose and one postdose ADA assessment were included in this analysis.
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.
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=132 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
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)
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 49 for Cohorts 1 and 2, and Baseline to Week 61 for Cohort 2Population: Participants with at least one predose and one postdose ADA assessment were included in this analysis.
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.
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=132 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Relationship Between ADA Status and Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Participants with at least one predose and one postdose ADA assessment were included in this analysis.
Descriptive statistics will be used for assessment.
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=132 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Relationship Between ADA Status and Serum Concentration of RO7105705 at Specified Timepoints
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Participants with at least one predose and one postdose ADA assessment were included in this analysis.
Descriptive statistics will be used for assessment.
Outcome measures
| Measure |
Semorinemab
n=135 Participants
Semorinemab was administered intravenously in the double-blind treatment period and was administered intravenously in the optional open-label extension period.
|
Placebo
n=132 Participants
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (Open-label Extension)
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Relationship Between ADA Status and Incidence of Anti-Drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
Positive Sample at BL
|
0 Participants
|
1 Participants
|
—
|
|
Relationship Between ADA Status and Incidence of Anti-Drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
Positive Sample post BL
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
NA Participants
Since there were no participants with ADAs, this relationship is not possible to establish.
|
—
|
Adverse Events
Semorinemab (Double Blind)
Serious events: 23 serious events
Other events: 78 other events
Deaths: 1 deaths
Placebo
Serious events: 22 serious events
Other events: 74 other events
Deaths: 3 deaths
Semorinemab (OLE)
Serious events: 37 serious events
Other events: 122 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Semorinemab (Double Blind)
n=135 participants at risk
Semorinemab was administered intravenously in the double-blind treatment period
|
Placebo
n=132 participants at risk
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (OLE)
n=199 participants at risk
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Cardiac disorders
Atrial fibrillation
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Cardiac disorders
Bradycardia
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.5%
2/132 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Gastrointestinal disorders
Colitis
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
General disorders
Death
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
COVID-19
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.5%
2/132 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.0%
2/199 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Cystitis
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Gastroenteritis
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.5%
2/132 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.0%
2/199 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Urinary tract infection
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.0%
2/199 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.5%
2/132 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
2.0%
4/199 • Number of events 4 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Investigations
SARS-CoV-2 test positive
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Dysarthria
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Seizure
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.0%
2/199 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Syncope
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.5%
3/199 • Number of events 3 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Upper motor neurone lesion
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
2.3%
3/132 • Number of events 3 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
1.5%
3/199 • Number of events 3 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Renal and urinary disorders
Renal failure
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.76%
1/132 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Vascular disorders
Hypotension
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
General disorders
Asthenia
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
General disorders
Hypothermia
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Hepatobiliary disorders
Biliary fistula
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Sepsis
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
2.5%
5/199 • Number of events 5 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 2 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Cerebellar infarction
|
0.74%
1/135 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/199 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.50%
1/199 • Number of events 1 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
Other adverse events
| Measure |
Semorinemab (Double Blind)
n=135 participants at risk
Semorinemab was administered intravenously in the double-blind treatment period
|
Placebo
n=132 participants at risk
Placebo was administered intravenously in the double-blind treatment period and semorinemab was administered intravenously in the optional open-label extension.
|
Semorinemab (OLE)
n=199 participants at risk
Semorinemab was administered intravenously in the optional open-label extension period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
7/135 • Number of events 7 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
3.8%
5/132 • Number of events 6 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
5.0%
10/199 • Number of events 10 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
9/135 • Number of events 10 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
2.3%
3/132 • Number of events 3 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
2.5%
5/199 • Number of events 5 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
Urinary tract infection
|
8.1%
11/135 • Number of events 14 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
12.1%
16/132 • Number of events 19 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
13.6%
27/199 • Number of events 36 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Fall
|
10.4%
14/135 • Number of events 20 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
14.4%
19/132 • Number of events 28 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
18.6%
37/199 • Number of events 64 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.4%
14/135 • Number of events 30 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
3.8%
5/132 • Number of events 9 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
7.0%
14/199 • Number of events 16 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
8/135 • Number of events 8 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
3.0%
4/132 • Number of events 4 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
5.5%
11/199 • Number of events 12 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Dizziness
|
5.9%
8/135 • Number of events 8 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
6.8%
9/132 • Number of events 11 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
3.5%
7/199 • Number of events 8 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Nervous system disorders
Headache
|
8.1%
11/135 • Number of events 14 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
6.8%
9/132 • Number of events 10 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
5.0%
10/199 • Number of events 13 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Psychiatric disorders
Agitation
|
5.9%
8/135 • Number of events 8 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
6.1%
8/132 • Number of events 8 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
9.0%
18/199 • Number of events 19 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Psychiatric disorders
Anxiety
|
6.7%
9/135 • Number of events 11 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
9.1%
12/132 • Number of events 12 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
5.5%
11/199 • Number of events 11 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Psychiatric disorders
Depression
|
7.4%
10/135 • Number of events 11 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
5.3%
7/132 • Number of events 7 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
3.0%
6/199 • Number of events 6 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Psychiatric disorders
Insomnia
|
5.2%
7/135 • Number of events 7 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
2.3%
3/132 • Number of events 3 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
6.5%
13/199 • Number of events 13 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Vascular disorders
Hypertension
|
5.9%
8/135 • Number of events 10 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
3.8%
5/132 • Number of events 5 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
2.5%
5/199 • Number of events 5 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
|
Infections and infestations
COVID-19
|
0.00%
0/135 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
0.00%
0/132 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
18.1%
36/199 • Number of events 36 • Baseline up to end of study (approximately 4 years and 7 months)
The safety population included all randomized participants who received at least one dose of either semorinemab or placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER