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

MedImmune LLC56 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Multiple Sclerosis, Relapsing Forms

Interventions

MEDI-551 30 MG-IVDRUG

Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.

MEDI-551 60 MG-SCDRUG

Participants received SC injection of 60 mg MEDI-551 on Day 1.

PLACEBO-IV-SCDRUG

Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed relapsing form of MS (ie, RRMS, SPMS, PRMS, or CIS) according to revised 2010 McDonald criteria and MRI brain lesions consistent with MS on screening * At least 1 documented relapse within the past 3 years prior to screening * EDSS between 0.0 and 6.5 at screening * Have no more than 20 Gd-enhancing T1 brain lesions detected by cranial MRI scan Exclusion Criteria: * Subjects with impaired renal function * Major surgery within 8 weeks of the screening visit * Subjects who are unable to undergo cranial MRI scan * A history of hypersensitivity to Gd-containing MRI contrast agents * Has received within 1 year prior to screening: monoclonal antibodies, experimental B-cell depleting agents, or treatment with natalizumab (Tysabri) for greater than 3 months * Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification of a relapsing form of MS * Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or to any component of the investigational drug * Diagnosis of PPMS, neuromyelitis optica, or other non-MS variant of neuro-inflammatory or demyelinating diseases * Any history of opportunistic infection or the presence of active infection within two months prior to screening or any herpes zoster infection that has not resolved within 12 weeks prior to screening * Any clinically significant findings during the screening phase, including physical, neurological, laboratory, or ECG examination as per protocol

Locations (16)

Research Site

Scottsdale, Arizona, United States

Research Site

Long Beach, California, United States

Research Site

Sacramento, California, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE were the events between administration of study drug (Day 1) and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0

Time frame: From study drug administration (Day 1) through the end of treatment period (Day 169)

Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect in the offspring of a participant who received the study drug. The TESAEs were the events between administration of study drug (Day 1) and long term follow up period (up to 18 months after early discontinuation visit or 24-week treatment period) that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0

Time frame: From study drug administration (Day 1) through the long term follow up period (up to 18 months after early discontinuation visit or 24 week treatment period).

Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs

Any clinically significant change in laboratory evaluations were recorded as AEs. The following parameters were analyzed for laboratory evaluations: haematology, serum chemistry, and urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.

Time frame: From study drug administration (Day 1) through the end of treatment period (Day 169)

Number of Participants With Vital Sign Abnormalities Reported as TEAEs

Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. The number of participants with TEAEs related to vital signs in participants were reported.

Data from ClinicalTrials.gov

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