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A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis — SCALA  

Progressive Multiple Sclerosis Clinical Trial

Official title:
A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis

Clinical Trial 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.

Clinical Trial Description

The duration of study per patient will be approximately 61 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02583594
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date December 6, 2015
Completion date March 1, 2021
View Details
See also
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