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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06292923 | A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients | PHASE2 | RECRUITING | 54 | — | — | Nov 15, 2023 | Nov 1, 2025 | Oct 15, 2025 | 7 | United States |
The TNSS is the sum of scores over 24 hours and 2 weeks for nasal congestion, runny nose, nasal itching, sneezing, and difficulty sleeping. The TNSS is quantified using the following scale: None 0, Mild 1 (symptom clearly present but easily tolerated), Moderate 2 (symptom bothersome but tolerable), Severe 3 (symptom difficult to tolerate - interferes with activities).
Subjects at all sites will undergo PET imaging with the radiotracer \[18F\]PBR06.
| Arm | Type | Description |
|---|---|---|
| Nasal Foralumab 50 μg | EXPERIMENTAL | Each patient will receive nasal foralumab 50 μg per dosing day (25 μg per nostril). |
| Nasal Foralumab 100 μg | EXPERIMENTAL | Each patient will receive nasal foralumab 100 μg per dosing day (50 μg per nostril). |
| Nasal placebo (acetate buffer) | PLACEBO_COMPARATOR | Each patient will receive placebo on each dosing day in divided doses, in each nostril. |
| Name | Type | Description |
|---|---|---|
| Foralumab | DRUG | Foralumab nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare). Each Unidose device contains foralumab nasal solution, supplied at either 25 μg foralumab or 50 μg foralumab, sufficient for administration into a single nare. |
| Placebo | OTHER | Foralumab placebo nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare). |
1. Confirmed diagnosis of MS according to the 2017 McDonald criteria . 2. Age 18 years to age 75 years. 3. Confirmed clinical diagnosis of non-active SPMS, for 2 years prior to the screening visit. The baseline study visit and/or the baseline MRI may not be used to confirm the diagnosis but will be ...