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

NCT02583594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-03-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-06
Primary Completion
2016-03-31
Completion
2021-03-01

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583594 on ClinicalTrials.gov