Trial Outcomes & Findings for Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients (NCT NCT02551809)
NCT ID: NCT02551809
Last Updated: 2020-03-17
Results Overview
Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
78 weeks
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
3 Priming Doses Followed by 4 Boosters
Subjects will receive 7 doses of UB-311.
UB-311: Intramuscular injection
|
3 Priming Doses Followed by 2 Boosters
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
UB-311: Intramuscular injection
Placebo: Intramuscular injection
|
Placebo
Subjects will receive 7 doses of placebo.
Placebo: Intramuscular injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
Baseline characteristics by cohort
| Measure |
3 Priming Doses Followed by 4 Boosters
n=14 Participants
Subjects will receive 7 doses of UB-311.
UB-311: Intramuscular injection
|
3 Priming Doses Followed by 2 Boosters
n=15 Participants
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
UB-311: Intramuscular injection
Placebo: Intramuscular injection
|
Placebo
n=14 Participants
Subjects will receive 7 doses of placebo.
Placebo: Intramuscular injection
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.4 years
STANDARD_DEVIATION 6.81 • n=5 Participants
|
72.5 years
STANDARD_DEVIATION 6.79 • n=7 Participants
|
72.0 years
STANDARD_DEVIATION 7.62 • n=5 Participants
|
72.6 years
STANDARD_DEVIATION 6.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
APOE4 carrier
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 78 weeksSafety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs.
Outcome measures
| Measure |
3 Priming Doses Followed by 4 Boosters
n=14 Participants
Subjects will receive 7 doses of UB-311.
UB-311: Intramuscular injection
|
3 Priming Doses Followed by 2 Boosters
n=15 Participants
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
UB-311: Intramuscular injection
Placebo: Intramuscular injection
|
Placebo
n=14 Participants
Subjects will receive 7 doses of placebo.
Placebo: Intramuscular injection
|
|---|---|---|---|
|
Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events
|
10 Participants
|
13 Participants
|
13 Participants
|
Adverse Events
3 Priming Doses Followed by 4 Boosters
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
3 Priming Doses Followed by 2 Boosters
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3 Priming Doses Followed by 4 Boosters
n=14 participants at risk
Subjects will receive 7 doses of UB-311.
UB-311: Intramuscular injection
|
3 Priming Doses Followed by 2 Boosters
n=15 participants at risk
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
UB-311: Intramuscular injection
Placebo: Intramuscular injection
|
Placebo
n=14 participants at risk
Subjects will receive 7 doses of placebo.
Placebo: Intramuscular injection
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • 78 weeks
|
0.00%
0/15 • 78 weeks
|
7.1%
1/14 • Number of events 1 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
7.1%
1/14 • Number of events 1 • 78 weeks
|
0.00%
0/15 • 78 weeks
|
0.00%
0/14 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/14 • 78 weeks
|
0.00%
0/15 • 78 weeks
|
7.1%
1/14 • Number of events 1 • 78 weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/14 • 78 weeks
|
6.7%
1/15 • Number of events 1 • 78 weeks
|
0.00%
0/14 • 78 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/14 • 78 weeks
|
6.7%
1/15 • Number of events 1 • 78 weeks
|
0.00%
0/14 • 78 weeks
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/14 • 78 weeks
|
6.7%
1/15 • Number of events 1 • 78 weeks
|
0.00%
0/14 • 78 weeks
|
Other adverse events
| Measure |
3 Priming Doses Followed by 4 Boosters
n=14 participants at risk
Subjects will receive 7 doses of UB-311.
UB-311: Intramuscular injection
|
3 Priming Doses Followed by 2 Boosters
n=15 participants at risk
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
UB-311: Intramuscular injection
Placebo: Intramuscular injection
|
Placebo
n=14 participants at risk
Subjects will receive 7 doses of placebo.
Placebo: Intramuscular injection
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/14 • 78 weeks
|
13.3%
2/15 • Number of events 2 • 78 weeks
|
7.1%
1/14 • Number of events 2 • 78 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • 78 weeks
|
6.7%
1/15 • Number of events 2 • 78 weeks
|
14.3%
2/14 • Number of events 3 • 78 weeks
|
|
Investigations
Weight decreased
|
14.3%
2/14 • Number of events 2 • 78 weeks
|
6.7%
1/15 • Number of events 2 • 78 weeks
|
7.1%
1/14 • Number of events 1 • 78 weeks
|
|
Nervous system disorders
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
|
14.3%
2/14 • Number of events 5 • 78 weeks
|
13.3%
2/15 • Number of events 3 • 78 weeks
|
14.3%
2/14 • Number of events 4 • 78 weeks
|
|
General disorders
Injection site pain
|
0.00%
0/14 • 78 weeks
|
26.7%
4/15 • Number of events 4 • 78 weeks
|
21.4%
3/14 • Number of events 10 • 78 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • 78 weeks
|
6.7%
1/15 • Number of events 1 • 78 weeks
|
28.6%
4/14 • Number of events 4 • 78 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site PIs must jointly publish results, unless permission is granted by Sponsor. If a joint publication is not done within 12 months after trial completion and database lock, then the site may publish its own results; provided that, a) Sponsor has 45 business days to review the proposed publication; b) the PI must delete any confidential information identified by Sponsor; and c) the PI must delay disclosure for 1 year if a patent application is filed by Sponsor.
- Publication restrictions are in place
Restriction type: OTHER