drugset / Trial / NCT02583594
A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: * To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab administered by subcutaneous injection and 2 treatment courses of alemtuzumab administered by intravenous infusion in patients with progressive multiple sclerosis. Secondary Objectives: * To characterize the pharmacokinetic profiles of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis. * To characterize the safety and tolerability of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.
Timeline
- Start
- 2015-12-06
- Primary completion
- 2016-03
- Completion
- 2021-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 12 mg | Intravenous |
| Background | Acetaminophen | Small molecule | — | Oral |
| Background | Acyclovir | Small molecule | — | Oral |
| Background | Ceterizine | Unknown | — | Oral |
| Background | Dexchlorpheniramine | Unknown | — | Oral |
| Background | Loratadine | Small molecule | — | Oral |
| Background | Methylprednisolone | Other / unclassified | — | Oral |