Trial Outcomes & Findings for An Open-Label Crenezumab Study in Participants With Alzheimer's Disease (NCT NCT03491150)
NCT ID: NCT03491150
Last Updated: 2020-07-13
Results Overview
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
TERMINATED
PHASE3
149 participants
Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
2020-07-13
Participant Flow
The study was conducted at 66 centers in 16 countries.
A total of 149 participants were enrolled at 66 centers. These 149 participants represented the Safety Analysis population and data for this population is presented here.
Participant milestones
| Measure |
Parent Placebo
Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
Parent Crenezumab
Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
73
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
76
|
73
|
Reasons for withdrawal
| Measure |
Parent Placebo
Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
Parent Crenezumab
Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
74
|
70
|
|
Overall Study
Other
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
An Open-Label Crenezumab Study in Participants With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Parent Placebo
n=76 Participants
Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
Parent Crenezumab
n=73 Participants
Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.8 Years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
72.0 Years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
72.9 Years
STANDARD_DEVIATION 7.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
69 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
72 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).Population: The Safety analysis population was defined as all participants who consented to the OLE study, including those who enrolled in the OLE but did not receive open-label treatment.
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Parent Placebo
n=76 Participants
Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
Parent Crenezumab
n=73 Participants
Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
32.9 Percentage of Participants
|
42.5 Percentage of Participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
3.9 Percentage of Participants
|
5.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of study (up to 54 weeks).Population: Please note that for this Outcome Measure, no Participants were evaluated at all as the existing immunogenicity data from a parent study (Study BN29552) showed a low potential of Crenezumab to induce Anti-Drug Antibodies (ADAs).
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Outcome measures
Outcome data not reported
Adverse Events
Parent Placebo
Parent Crenezumab
Serious adverse events
| Measure |
Parent Placebo
n=76 participants at risk
Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
Parent Crenezumab
n=73 participants at risk
Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
|---|---|---|
|
Eye disorders
OPTIC ISCHAEMIC NEUROPATHY
|
0.00%
0/76 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
1.4%
1/73 • Number of events 1 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
|
Gastrointestinal disorders
INCARCERATED INGUINAL HERNIA
|
1.3%
1/76 • Number of events 1 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
0.00%
0/73 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
1.3%
1/76 • Number of events 1 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
0.00%
0/73 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/76 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
1.4%
1/73 • Number of events 1 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/76 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
1.4%
1/73 • Number of events 1 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/76 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
1.4%
1/73 • Number of events 1 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.3%
1/76 • Number of events 1 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
0.00%
0/73 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
Other adverse events
| Measure |
Parent Placebo
n=76 participants at risk
Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
Parent Crenezumab
n=73 participants at risk
Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
|
|---|---|---|
|
Injury, poisoning and procedural complications
FALL
|
5.3%
4/76 • Number of events 5 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
5.5%
4/73 • Number of events 4 • Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
|
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