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 (SCALA)

NCT02583594 Phase 1 COMPLETED

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.

Details

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2015-12-06
Completion	2021-03-01

Conditions

• Progressive Multiple Sclerosis

Interventions

• Acyclovir
• Methylprednisolone
• alemtuzumab GZ402673
• alemtuzumab GZ402673
• Paracetamol
• Loratadine
• Ceterizine
• Dexchlorpheniramine

Primary outcomes

• Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration — Baseline, 30 days after each treatment course

Countries

Spain