Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03987295 | A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2) | PHASE2 | COMPLETED | 33 | — | — | Sep 27, 2019 | Jun 5, 2024 | Dec 5, 2025 | 12 | United States, Canada +4 |
Number of TEAEs categorized by severity
Number of treatment-related TEAEs categorized by severity
Number of TEAEs leading to study drug discontinuation
Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study
Presence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study).
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.
| Arm | Type | Description |
|---|---|---|
| Granulin and C9orf72 | EXPERIMENTAL | IV administration of AL001; 60 mg/kg, every 4 weeks \[q4w\] |
| Name | Type | Description |
|---|---|---|
| AL001 | DRUG | 60 mg/kg of AL001 every 4 weeks |
Inclusion Criteria: * At screening, female participants must be nonpregnant and nonlactating * In good physical health on the basis of no clinically significant findings from medical history, physical examinations (PEs), laboratory tests, ECGs, and vital signs. * Participant is a carrier of a loss ...