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

Novartis

Status and phase

Completed

Phase 4

Conditions

Relapsing Multiple Sclerosis

Treatments

Biological: Ofatumumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05199571

COMB157G2402

Details and patient eligibility

About

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

Full description

This study consisted of three periods, Screening (up to 30 days), Treatment (12 months) and Post-treatment follow-up (6 months). It was an open-label single-arm study so all participants received the study drug. The first dose was administered in the clinic and the remaining doses were administered at home. The doses were administered at Baseline/Week 0, Week 1, Week 2, and followed by subsequent monthly dosing starting at Week 4.

Participants were 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 completed the 12-month treatment had Post treatment Follow-Up visits at End of Study plus 3 months (EOS + 3M) and EOS + 6M, unless the participants decided to continue with commercially available ofatumumab treatment outside of the study.

Enrollment

99 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.