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

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

ClinicalTrials.gov Identifier: NCT05199571

Novartis Reference Number: COMB157G2402

Last Update: Jan 12, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Relapsing Multiple Sclerosis

Phase

Phase 4

Overall status

Recruiting

Start date

Jul 22, 2022

Completion date

May 12, 2026

Gender

All

Age(s)

18 Years - 55 Years (Adult)

Interventions

Biological

Ofatumumab

Solution for injection in an autoinjector (pre-filled pen) containing 20 mg ofatumumab

Eligibility Criteria

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.