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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis, Relapsing Forms

Treatments: Drug: MEDI-551 30 MG-IV; Drug: MEDI-551 100 MG-IV; Drug: MEDI-551 600 MG-IV; Drug: PLACEBO-IV-SC; Drug: MEDI-551 60 MG-SC; Drug: MEDI-551 300 MG-SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01585766

CD-IA-MEDI-551-1102

Details and patient eligibility

About

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).

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 6 patient groups, including a placebo group

MEDI-551 30 MG-IV

Experimental group

Description:

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

Treatment:

Drug: MEDI-551 30 MG-IV

MEDI-551 60 MG-SC

Experimental group

Description:

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

Treatment:

Drug: MEDI-551 60 MG-SC

MEDI-551 100 MG-IV

Experimental group

Description:

Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.

Treatment:

Drug: MEDI-551 100 MG-IV

MEDI-551 300 MG-SC

Experimental group

Description:

Participants received SC injection of 300 mg MEDI-551 on Day 1.

Treatment:

Drug: MEDI-551 300 MG-SC

MEDI-551 600 MG-IV

Experimental group

Description:

Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.

Treatment:

Drug: MEDI-551 600 MG-IV

PLACEBO-IV-SC

Placebo Comparator group

Description:

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

Treatment:

Drug: PLACEBO-IV-SC