Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of ofatumumab s.c. in adult participants with relapsing multiple sclerosis (RMS) in China.

Detailed Description
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This study consists of three periods, Screening (up to 30 days), Treatment (12 months) and Post-treatment follow-up (6 months). It is an open-label single-arm study so all participants will receive the study drug. The first dose will be administered in the clinic and the remaining doses may be administered at home. The doses are administered at Baseline/Week 0, Week 1, Week 2, and followed by subsequent monthly dosing starting at Week 4. Participants will be required to come into the clinic for one screening visit, and 5 visits during the Treatment period for clinical evaluation and lab tests. Participants who complete the 12-month treatment will have Post treatment Follow-Up visits at End of Study plus 3 months (EOS + 3M) and EOS + 6M, unless the participants decide to continue with commercially available ofatumumab treatment outside of the study.

Official Title
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A 12-month, Open-label, Prospective, Multicenter, Interventional, Single-arm Study Assessing the Efficacy and Safety of Ofatumumab 20 mg Subcutaneous (s.c.) Injection in Relapsing Multiple Sclerosis (RMS) Patients in China

Conditions
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Relapsing Multiple Sclerosis

Intervention / Treatment
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* Biological: Ofatumumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Chinese aged 18-55 years (inclusive) at their enrollment of the study (signing the study consent form). Clinical definite diagnosis of RMS according to the 2017 Revised McDonald criteria (Thompson et al 2018, and the documentation prior to their enrollment to the study (signing the study consent form) of: Two documented relapses during the past 2 years, or One documented relapse during the last year, or A positive Gd-enhancing MRI scan during the year prior to Screening. Note: Screening MRI scan may be used if no positive Gd-enhancing scan exists from prior year. Disability status with an EDSS score of 0 - 5.5 (inclusive) at Screening. Neurologically stable within 1 month prior to both Screening and Baseline (including no MS relapse in this period). Exclusion Criteria: Participants with primary progressive MS (PPMS) or secondary progressive MS (SPMS) without disease activity Participants meeting criteria for neuromyelitis optica spectrum disorder (NMOSD) Pregnant or nursing (lactating) women Women of child-bearing potential unless using effective methods of contraception while taking study treatment and for at least 6 months after stopping medication Participants with an active chronic disease of the immune system other than MS Participants with neurological findings consistent with PML or confirmed PML Participants with active hepatitis B disease Participants with active systemic infections (including but not limited to active COVID-19 infection) or known to have AIDS or to test positive for HIV antibody at Screening Participants at high risk of developing or having reactivation of syphilis or tuberculosis Have received any live or live-attenuated vaccines within four weeks prior to first study drug administration Have been treated with medications as specified or within timeframes specified in the protocol Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the participants to cooperate and comply with the study procedures. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ofatumumab<br>Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4 | Biological: Ofatumumab<br>* Solution for injection in an autoinjector (pre-filled pen) containing 20 mg ofatumumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized relapse rate (ARR) | ARR is the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. A confirmed MS relapse is defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). Comparisons are made to the previous rating (the last EDSS rating that does not occur during a relapse). | Baseline up to approximately 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events and serious adverse events | Adverse events and SAEs, including clinically significant laboratory data and vital signs which meet the definition of adverse events | Baseline up to approximately 18 months | 
| Number of gadolinium (Gd)-enhancing T1 lesions per MRI scan | Average number of Gd-enhancing T1 lesions per scan | Baseline up to approximately 18 months | 
| Annualized rate of new or enlarging T2 lesion | Number of new/newly enlarged T2 lesions per year. | Baseline up to approximately 18 months | 
| Percent change in T2 lesion volume relative to baseline | Percent change from baseline in total T2 lesion volume | Baseline up to approximately 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing multiple sclerosis, open-label, interventional, efficacy and safety, ofatumumab, China, adult, OMB157