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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07161999 | Study of COYA 302 for the Treatment of ALS | PHASE2 | RECRUITING | 120 | — | — | Oct 1, 2025 | Jul 1, 2027 | May 20, 2026 | 25 | United States, Canada |
The ALSFRS-R is an ordinal rating scale used to determine a participant's subjective assessment of their capability and independence with 12 functional activities. The maximal score is 48.
| Arm | Type | Description |
|---|---|---|
| DB: COYA 302 Regimen 1 | EXPERIMENTAL | Regimen 1: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Week 1) and matching placebo (Week 3) administered via subcutaneous (SC) injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| DB: COYA 302 Regimen 2 | EXPERIMENTAL | Regimen 2: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Weeks 1 and 3) administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| DB: Placebo | PLACEBO_COMPARATOR | Placebo LD IL-2 and Placebo DRL\_AB (Weeks 1 and 3) administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| EXT: Regimen 1 | EXPERIMENTAL | Regimen 1: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Week 1) and matching placebo (week 3) administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| EXT: Regimen 2 | EXPERIMENTAL | Regimen 2: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Weeks 1 and 3) administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| Name | Type | Description |
|---|---|---|
| COYA 302 | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: 1. Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria 2. Male or female participants aged 18 to 80 3. Time since onset of ALS symptoms ≤28 months from Screening. 4. ALSFRS-R total ...