drugset / Trial / NCT01764737
Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in patients with multiple sclerosis. The escalation part of the study will determine the maximum tolerated dose (MTD) or the Maximum Administered Dose if no MTD is found.
Timeline
- Start
- 2012-12
- Primary completion
- 2014-11
- Completion
- 2014-11
Publications
- LaGanke C, Samkoff L, Edwards K, Jung Henson L, Repovic P, Lynch S, Stone L, Mattson D, Galluzzi A, Fisher TL, Reilly C, Winter LA, Leonard JE, Zauderer M. Safety/tolerability of the anti-semaphorin 4D Antibody VX15/2503 in a randomized phase 1 trial. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 16;4(4):e367. doi: 10.1212/NXI.0000000000000367. eCollection 2017 Jul.
- Worzfeld T, Offermanns S. Semaphorins and plexins as therapeutic targets. Nat Rev Drug Discov. 2014 Aug;13(8):603-21. doi: 10.1038/nrd4337.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pepinemab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Pepinemab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Pepinemab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Pepinemab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Pepinemab | Monoclonal antibody | 20 mg/kg | Intravenous |