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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06890923 | Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis | PHASE2 | RECRUITING | 55 | — | — | Mar 4, 2025 | Aug 30, 2026 | Jun 6, 2025 | 1 | United States |
The safety and tolerability of 50 µg/dose and 100 µg/doses of foralumab nasal as measured by adverse event reports
Assess change in baseline Modified Fatigue Impact Scale (MFIS) Scores range from 0-84. 0 is the minimum score and 84 is the maximum score. Lower scores indicate less fatigue while higher scores indicate increased fatigue.
| Arm | Type | Description |
|---|---|---|
| Nasal foralumab 50 μg per dosing day (25 μg per nostril) | EXPERIMENTAL | All patients will initially receive nasal foralumab 50 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles. |
| Name | Type | Description |
|---|---|---|
| Foralumab TZLS-401 100 µg | DRUG | Patients meeting the requirements of the dose escalation rules will receive nasal foralumab 100 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles. |
Inclusion Criteria: * Subjects must have enrolled in and successfully completed TILS-021 within the preceding 90 days, including End of Treatment and End of Study assessments. * Screening clinical laboratory studies are within the normal ranges or within the parameters specified below, and clinical...