NCT01585766

Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis

A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).

Detailed description

This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS.

Conditions

• Multiple Sclerosis, Relapsing Forms

Interventions

Type	Name	Description
DRUG	MEDI-551 30 MG-IV	Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
DRUG	MEDI-551 60 MG-SC	Participants received SC injection of 60 mg MEDI-551 on Day 1.
DRUG	PLACEBO-IV-SC	Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1
DRUG	MEDI-551 100 MG-IV	Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
DRUG	MEDI-551 300 MG-SC	Participants received SC injection of 300 mg MEDI-551 on Day 1.
DRUG	MEDI-551 600 MG-IV	Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.

Timeline

• Start date: 2012-04-24
• Primary completion: 2015-01-02
• Completion: 2016-06-20
• First posted: 2012-04-26
• Last updated: 2018-10-29
• Results posted: 2018-10-29

Locations

16 sites across 4 countries: United States, Poland, Spain, Ukraine

Regulatory

• FDA-regulated drug study