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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03737812 | A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis | PHASE2 | COMPLETED | 123 | — | — | Feb 27, 2019 | Aug 30, 2021 | Dec 21, 2023 | 37 | United States, Canada |
| NCT03737851 | A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis | PHASE2 | COMPLETED | 208 | — | — | Dec 11, 2018 | Sep 9, 2021 | Dec 22, 2023 | 49 | United States, Canada |
The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.
The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants randomized to receive placebo by intravenous infusion. |
| Elezanumab 400mg Dose | EXPERIMENTAL | Participants randomized to receive 400mg of elezanumab by intravenous infusion. |
| Elezanumab 1800 mg Dose | EXPERIMENTAL | Participants randomized to receive 1800mg of elezanumab by intravenous infusion. |
| Elezanumab Dose 1 | EXPERIMENTAL | Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion. |
| Elezanumab Dose 2 | EXPERIMENTAL | Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| elezanumab | DRUG | solution for infusion |
| placebo | DRUG | solution for infusion |
Inclusion Criteria: * Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months. * Evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25...