Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
Status:
Active, not recruiting
Sponsors
Novartis Pharmaceuticals
Abstract:
The study will provide efficacy, safety, tolerability and pharmacokinetics data for ofatumumab 20 mg subcutaneous injections every 4 weeks compared with placebo for 24 weeks in patients from Japan and the other countries and also provide the extended efficacy, safety, tolerability and pharmacokinetics data.
Description:
This study has 2 parts: A controlled Core and an open-label Extension.
- Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group, multicenter study to evaluate the efficacy, safety and tolerability and PK of ofatumumab in patients with relapsing MS.
- Extension part: The Core part is followed by an Extension part in which all patients receive open-label ofatumumab. In the Extension part, patients are treated for at least 24 weeks and no longer than 48 weeks.
Approximately 60 patients will be randomized in a 2:1 ratio to ofatumumab or placebo in the Core part; half of the study patients will be from Japan and the other half from the other countries.
Last Verified:May/31/2020
First Submitted:August/10/2017
Estimated Enrollment Submitted:August/10/2017
First Posted:August/14/2017
Last Update Submitted:May/31/2020
Last Update Posted:June/1/2020
Actual Study Start Date:March/14/2018
Estimated Primary Completion Date:February/9/2020
Estimated Study Completion Date:June/21/2020
Condition or disease:Relapsing Multiple Sclerosis
Intervention/treatment:
Drug: Ofatumumab arm
Drug: Placebo arm
Phase:Phase 2
Study design:
Study Type:Interventional
Primary Purpose:Treatment
Masking:Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm group:
ArmIntervention/treatment
Experimental: Ofatumumab arm
Ofatumumab 20 mg subcutaneous injections every 4 weeks for 24 weeks
Drug: Ofatumumab arm
Patients randomized to the ofatumumab arm will receive subcutaneous injections of ofatumumab every 4 weeks
Placebo Comparator: Placebo arm
Placebo subcutaneous injection matching to ofatumumab every 4 weeks for 24 weeks
Drug: Placebo arm
Patients randomized to the placebo arm will receive subcutaneous injections of placebo every 4 weeks
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
Criteria:

Inclusion Criteria:

- Diagnosis of multiple sclerosis (MS)

- Relapsing MS

- 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-enhanced 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 Other protocol-defined inclusion/exclusion criteria may apply

Outcome:
Primary Outcome Measures
1. Mean number of gadolinium enhanced T1 lesions across 4 MRI scans (ofatumumab vs placebo) [Week 12, 16, 20 and 24]
The number of gadolinium enhanced T1 lesions on MRI scans will be measured by the central MRI reading center.
Secondary Outcome Measures
1. Mean number of gadolinium enhanced T1 lesions across 4 MRI scans (Japan vs other countries) [Week 12, 16, 20 and 24, 36, 48 and end of study up to Week 72]
The number of gadolinium enhanced T1 lesions on MRI scans will be measured by the central MRI reading center.
2. Number of new or enlarging T2 lesions on MRI scans compared to baseline [Baseline, Week 12, 16, 20 and 24, 36, 48 and end of study up to Week 72]
The number of new or enlarging T2 lesions on MRI scans compared to baseline will be measured by the central MRI reading center.
3. Annualized relapse rate [Week 24, 48 and end of study up to Week 72]
Annualized relapse rate is the number of confirmed relapses in a year calculated based on cumulative number of relapses.
4. B-cell count [Baseline, Day 2, 5, 7, 14, Week 4, 12, 24, 28, 36, 48, 60 and 72]
Blood samples will be collected at the scheduled visit. The CD19+ B-cell count will be measured by the central laboratory.
5. Time to first relapse [Week 24, 48 and end of study up to Week 72]
Time to first relapse is the period until the first relapse is confirmed from the first study drug injection.
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