NCT02583594

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Acyclovir	Pharmaceutical form:tablet Route of administration: oral
DRUG	Methylprednisolone	Pharmaceutical form:tablet Route of administration: oral
DRUG	alemtuzumab GZ402673	Pharmaceutical form:solution for infusion Route of administration: intravenous
DRUG	alemtuzumab GZ402673	Pharmaceutical form:injection Route of administration: subcutaneous
DRUG	Paracetamol	Pharmaceutical form:tablet Route of administration: oral
DRUG	Loratadine	Pharmaceutical form:tablet Route of administration: oral
DRUG	Ceterizine	Pharmaceutical form:tablet Route of administration: oral
DRUG	Dexchlorpheniramine	Pharmaceutical form:tablet Route of administration: oral

Timeline

• Start date: 2015-12-06
• Primary completion: 2016-03-01
• Completion: 2021-03-01
• First posted: 2015-10-22
• Last updated: 2021-03-10

Locations

1 site across 1 country: Spain