Trial Outcomes & Findings for A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2) (NCT NCT03987295)
NCT ID: NCT03987295
Last Updated: 2025-12-05
Results Overview
Number of TEAEs categorized by severity
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
197 weeks
Results posted on
2025-12-05
Participant Flow
Participant milestones
| Measure |
aFTD-GRN
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
12
|
16
|
|
Overall Study
COMPLETED
|
5
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)
Baseline characteristics by cohort
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=12 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=16 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=37 Participants
|
7 Participants
n=37 Participants
|
11 Participants
n=74 Participants
|
23 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
10 Participants
n=267 Participants
|
|
Age, Continuous
|
59.0 years
n=37 Participants
|
59.5 years
n=37 Participants
|
60.0 years
n=74 Participants
|
59.0 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=37 Participants
|
4 Participants
n=37 Participants
|
9 Participants
n=74 Participants
|
14 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=37 Participants
|
8 Participants
n=37 Participants
|
7 Participants
n=74 Participants
|
19 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
2 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=37 Participants
|
10 Participants
n=37 Participants
|
16 Participants
n=74 Participants
|
31 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=37 Participants
|
10 Participants
n=37 Participants
|
16 Participants
n=74 Participants
|
31 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
2 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 197 weeksPopulation: There is no statistical analysis for this primary end point.
Number of TEAEs categorized by severity
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=12 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=16 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Severity of TEAEs
Mild
|
43 TEAEs (all)
|
58 TEAEs (all)
|
84 TEAEs (all)
|
|
Severity of TEAEs
Moderate
|
4 TEAEs (all)
|
9 TEAEs (all)
|
24 TEAEs (all)
|
|
Severity of TEAEs
Severe
|
3 TEAEs (all)
|
1 TEAEs (all)
|
4 TEAEs (all)
|
|
Severity of TEAEs
Life Threatening
|
0 TEAEs (all)
|
0 TEAEs (all)
|
0 TEAEs (all)
|
|
Severity of TEAEs
Death
|
0 TEAEs (all)
|
0 TEAEs (all)
|
1 TEAEs (all)
|
PRIMARY outcome
Timeframe: 197 weeksPopulation: There is no statistical analysis for this primary end point.
Number of treatment-related TEAEs categorized by severity
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=12 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=16 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Severity of Treatment-Related TEAEs
Severe
|
0 TEAEs (treatment-related)
|
0 TEAEs (treatment-related)
|
0 TEAEs (treatment-related)
|
|
Severity of Treatment-Related TEAEs
Life Threatening
|
0 TEAEs (treatment-related)
|
0 TEAEs (treatment-related)
|
0 TEAEs (treatment-related)
|
|
Severity of Treatment-Related TEAEs
Death
|
0 TEAEs (treatment-related)
|
0 TEAEs (treatment-related)
|
0 TEAEs (treatment-related)
|
|
Severity of Treatment-Related TEAEs
Moderate
|
1 TEAEs (treatment-related)
|
1 TEAEs (treatment-related)
|
5 TEAEs (treatment-related)
|
|
Severity of Treatment-Related TEAEs
Mild
|
5 TEAEs (treatment-related)
|
1 TEAEs (treatment-related)
|
12 TEAEs (treatment-related)
|
PRIMARY outcome
Timeframe: 197 weeksPopulation: There is no statistical analysis for this primary end point.
Number of TEAEs leading to study drug discontinuation
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=12 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=16 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Any TEAE Leading to Study Drug Discontinuation
|
0 TEAE leading to discontinuation
|
1 TEAE leading to discontinuation
|
1 TEAE leading to discontinuation
|
PRIMARY outcome
Timeframe: 97 weeksPopulation: There is no statistical analysis for this primary end point.
Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=12 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=16 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Immunogenicity Antidrug Antibodies (ADA) Titer
Week 73 - ADA Titer
|
0 Titers
Interval 0.0 to 0.0
|
160.0 Titers
Interval 160.0 to 160.0
|
0 Titers
Interval 0.0 to 0.0
|
|
Immunogenicity Antidrug Antibodies (ADA) Titer
Week 61 - ADA Titer
|
0 Titers
Interval 0.0 to 0.0
|
0 Titers
Interval 0.0 to 0.0
|
160.0 Titers
Interval 160.0 to 160.0
|
|
Immunogenicity Antidrug Antibodies (ADA) Titer
Week 85 - ADA Titer
|
0 Titers
Interval 0.0 to 0.0
|
160.0 Titers
Interval 160.0 to 160.0
|
20.0 Titers
Interval 20.0 to 20.0
|
|
Immunogenicity Antidrug Antibodies (ADA) Titer
Week 97 - ADA Titer
|
20.0 Titers
Interval 20.0 to 20.0
|
0 Titers
Interval 0.0 to 0.0
|
160.0 Titers
Interval 160.0 to 160.0
|
|
Immunogenicity Antidrug Antibodies (ADA) Titer
Week 2 - ADA Titer
|
320.0 Titers
Interval 20.0 to 5120.0
|
20.0 Titers
Interval 20.0 to 2560.0
|
40.0 Titers
Full Range 0.00 • Interval 20.0 to 160.0
|
|
Immunogenicity Antidrug Antibodies (ADA) Titer
Week 13 - ADA Titer
|
160.0 Titers
Interval 20.0 to 2560.0
|
160.0 Titers
Interval 160.0 to 640.0
|
120.0 Titers
Interval 80.0 to 160.0
|
|
Immunogenicity Antidrug Antibodies (ADA) Titer
Week 25 - ADA Titer
|
320.0 Titers
Interval 320.0 to 320.0
|
330.0 Titers
Interval 20.0 to 640.0
|
80.0 Titers
Interval 20.0 to 160.0
|
|
Immunogenicity Antidrug Antibodies (ADA) Titer
Week 37 - ADA Titer
|
0 Titers
Interval 0.0 to 0.0
|
80.0 Titers
Interval 20.0 to 320.0
|
90.0 Titers
Interval 20.0 to 160.0
|
|
Immunogenicity Antidrug Antibodies (ADA) Titer
Week 49 - ADA Titer
|
0 Titers
Interval 0.0 to 0.0
|
320.0 Titers
Interval 40.0 to 640.0
|
20.0 Titers
Interval 20.0 to 20.0
|
PRIMARY outcome
Timeframe: 97 weeksPresence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study).
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=5 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=9 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses
ADA Positive
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses
ADA Negative
|
4 Participants
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 197 weeksPopulation: There is no statistical analysis for this primary endpoint.
The Sheehan Suicidality Tracking Scale (S-STS) is a structured assessment tool used to evaluate the presence, severity, and frequency of suicidal ideation and behavior. It includes items that address passive thoughts of death, active suicidal ideation, intent, planning, suicide attempts, and non-suicidal self-injury. The S-STS total score ranges from 0 to 64, based on 16 items each rated from 0 (not at all) to 4 (extremely), with higher scores indicating greater severity of suicidal ideation, intent, or behavior. The total score provides a quantitative measure of suicidality severity and is sensitive to change over time, making it suitable for clinical monitoring and research use.
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=1 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=3 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Change From Baseline in Sheehan Suicidality Tracking Scale
|
0 Scores
Standard Deviation 0
|
0 Scores
|
0 Scores
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 97 weeksPopulation: There is no statistical analysis for this secondary end point.
The percent change from baseline to specified timepoints of PGRN in CSF. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.
Outcome measures
| Measure |
aFTD-GRN
n=4 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=8 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=11 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Longitudinal Percent Change From Baseline of CSF PGRN
Week 49
|
198.16 percent change of ug/L
Standard Deviation 110.255
|
104.05 percent change of ug/L
Standard Deviation 103.349
|
101.61 percent change of ug/L
Standard Deviation 38.492
|
|
Longitudinal Percent Change From Baseline of CSF PGRN
Week 97
|
189.46 percent change of ug/L
Standard Deviation 113.802
|
59.73 percent change of ug/L
Standard Deviation 24.034
|
144.73 percent change of ug/L
Standard Deviation 54.994
|
SECONDARY outcome
Timeframe: 97 weeksPopulation: There is no statistical analysis for this secondary end point.
The percent change from baseline to specified timepoints for PGRN in plasma. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=12 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=16 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Longitudinal Percent Change From Baseline in Plasma PGRN
Week 49
|
177.39 percent change in ug/L
Standard Deviation 51.352
|
151.32 percent change in ug/L
Standard Deviation 59.321
|
178.82 percent change in ug/L
Standard Deviation 58.406
|
|
Longitudinal Percent Change From Baseline in Plasma PGRN
Week 97
|
185.37 percent change in ug/L
Standard Deviation 43.763
|
188.12 percent change in ug/L
Standard Deviation 47.847
|
157.93 percent change in ug/L
Standard Deviation 92.695
|
SECONDARY outcome
Timeframe: 97 weeksPopulation: WBC samples for analysis for Sortilin expression were collected to serve as a pharmacodynamic biomarker of target engagement. Development of this assay found that stability of these samples was not reliable for accurate measurement. Hence, we did not measure Sortilin in this study.
The overall change from baseline in Sortilin in WBCs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 97 weeksPopulation: There is no statistical analysis for this secondary end point.
Serum concentration of Latozinemab at week 97.
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=2 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=7 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Latozinemab Concentration in Serum
|
236000 ng/mL
Standard Deviation 69100
|
250000 ng/mL
Standard Deviation 24700
|
265000 ng/mL
Standard Deviation 77000
|
SECONDARY outcome
Timeframe: 97 weeksPopulation: There is no statistical analysis for this secondary end point.
Maximum observed concentration of Latozinemab at week 96 of treatment.
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=2 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=7 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Cmax of Latozinemab at Specified Timepoints
|
1810 ug/mL
Standard Deviation 352
|
1320 ug/mL
Standard Deviation 255
|
1510 ug/mL
Standard Deviation 145
|
SECONDARY outcome
Timeframe: 97 weeksPopulation: There is no statistical analysis for this secondary endpoint.
Trough concentration of Latozinemab at week 96 of treatment
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=2 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=14 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Ctrough of Latozinemab at Specified Timepoints
|
236 ug/mL
Standard Deviation 69.1
|
250 ug/mL
Standard Deviation 24.7
|
252 ug/mL
Standard Deviation 66.7
|
SECONDARY outcome
Timeframe: 61 weeksPopulation: There is no statistical analysis for this endpoint.
Ratio of latozinemab Cmax at week 61 to the Cmax at week 1
Outcome measures
| Measure |
aFTD-GRN
n=5 Participants
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=8 Participants
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=10 Participants
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
ARCmax of Latozinemab
|
1.22 Ratio
Standard Deviation 0.192
|
1.23 Ratio
Standard Deviation 0.236
|
1.39 Ratio
Standard Deviation 0.712
|
Adverse Events
aFTD-GRN
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
FTD-GRN
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
FTD-C9orf72
Serious events: 2 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
aFTD-GRN
n=5 participants at risk
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=12 participants at risk
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=16 participants at risk
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
12.5%
2/16 • Number of events 3 • 197 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Psychiatric disorders
Aggression
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
Other adverse events
| Measure |
aFTD-GRN
n=5 participants at risk
aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-GRN
n=12 participants at risk
FTD-GRN - symptomatic carriers of GRN mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
FTD-C9orf72
n=16 participants at risk
FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD
Part 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \[q4w\]), for a total of 25 doses (96-week dosing period).
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Actinic keratosis
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Psychiatric disorders
Illusion
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Psychiatric disorders
Impulsive behavior
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • 197 weeks
|
16.7%
2/12 • Number of events 2 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Product Issues
Device physical property issue
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Investigations
Blood cholesterol increased
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Investigations
Blood potassium increased
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Investigations
Lipase increased
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
40.0%
2/5 • Number of events 2 • 197 weeks
|
41.7%
5/12 • Number of events 5 • 197 weeks
|
43.8%
7/16 • Number of events 7 • 197 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/5 • 197 weeks
|
16.7%
2/12 • Number of events 2 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Injury, poisoning and procedural complications
Sunburn
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Injury, poisoning and procedural complications
Weight increased
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Cardiac disorders
Angina pectoris
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Nervous system disorders
Aphasia
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Nervous system disorders
Carotid artery stenosis
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Number of events 2 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
12.5%
2/16 • Number of events 2 • 197 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Nervous system disorders
Parkinsonian rest tremor
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • 197 weeks
|
16.7%
2/12 • Number of events 2 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Eye disorders
Blepharitis
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Eye disorders
Episcleritis
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • 197 weeks
|
16.7%
2/12 • Number of events 2 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
12.5%
2/16 • Number of events 2 • 197 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • 197 weeks
|
16.7%
2/12 • Number of events 2 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Renal and urinary disorders
Urinary retention
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Endocrine disorders
Goitre
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • Number of events 2 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
COVID-19
|
40.0%
2/5 • Number of events 2 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
31.2%
5/16 • Number of events 5 • 197 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Ear infection
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Infections and infestations
Eye infection bacterial
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Lyme disease
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Otitis externa
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
2/5 • Number of events 2 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
16.7%
2/12 • Number of events 2 • 197 weeks
|
37.5%
6/16 • Number of events 6 • 197 weeks
|
|
Infections and infestations
Viral rhinitis
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Infections and infestations
Eye contusion
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
Vascular disorders
Subclavian artery occlusion
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
General disorders
Administration site extravasation
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
General disorders
Crying
|
0.00%
0/5 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
6.2%
1/16 • Number of events 1 • 197 weeks
|
|
General disorders
Fatigue
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • 197 weeks
|
8.3%
1/12 • Number of events 1 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
General disorders
Infusion site extravasation
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
General disorders
Infusion site pain
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
|
General disorders
Infusion site paraesthesia
|
20.0%
1/5 • Number of events 1 • 197 weeks
|
0.00%
0/12 • 197 weeks
|
0.00%
0/16 • 197 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Alector's agreements with principal investigators may vary but will not prohibit any investigator from publishing. Alector supports the publication of the results from all centers in a multi-center trial, and its agreements include provisions to enable the multi-center publication to occur before publication of data from a single site.
- Publication restrictions are in place
Restriction type: OTHER