Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

Novartis

Status and phase: Completed; Phase 2

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: Matching placebo of ofatumumab; Drug: Ofatumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03249714

COMB157G1301

Details and patient eligibility

About

The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries

Full description

This study had 2 parts: A controlled Core and an open-label Extension.

• Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group, multicenter study evaluated the efficacy, safety and tolerability and PK of ofatumumab in patients with RMS.
• Extension part: The Core part was followed by an Extension part in which all patients received open-label ofatumumab. In the Extension part, patients were treated for at least 24 weeks and no longer than 48 weeks.

Sixty-four patients were randomized in a 2:1 ratio to ofatumumab or placebo in the Core part; half of the study patients were from Japan and the other half from the other countries.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of multiple sclerosis (MS)
• Relapsing MS (RMS)
• At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhancing T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization
• EDSS score of 0 to 5.5

Exclusion criteria

• Primary progressive MS or SPMS without disease activity
• Patients with an active chronic disease of the immune system other than MS
• Patients at risk of developing or having reactivation of hepatitis
• Patients with active systemic infections or with neurological findings consistent with PML

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

OMB 20 mg

Experimental group

Description:

Ofatumumab 20 mg subcutaneous injection on Days 1,7, 14 and every 4 weeks for 24 weeks in Core. Core placebo patients received loading dose at Weeks 25 and 26 and then all Extension patients received dose every 4 Weeks up to Week 48.

Treatment:

Drug: Ofatumumab

Placebo

Placebo Comparator group

Description:

Placebo subcutaneous injection matching to ofatumumab every 4 weeks for 24 weeks in Core

Treatment:

Drug: Matching placebo of ofatumumab