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

NCT ID: NCT05199571

Last Updated: 2025-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2025-02-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Relapsing Multiple Sclerosis

Keywords

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Relapsing multiple sclerosis open-label interventional efficacy and safety ofatumumab China adult OMB157

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ofatumumab

Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4

Group Type EXPERIMENTAL

Ofatumumab

Intervention Type BIOLOGICAL

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

Interventions

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Ofatumumab

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

Intervention Type BIOLOGICAL

Other Intervention Names

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OMB157

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Lanzhou, Gansu, China

Site Status

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Shijiazhuang, Hebei, China

Site Status

Novartis Investigative Site

Harbin, Heilongjiang, China

Site Status

Novartis Investigative Site

Wuhan, Hubei, China

Site Status

Novartis Investigative Site

Suzhou, Jiangsu, China

Site Status

Novartis Investigative Site

Shenyang, Liaoning, China

Site Status

Novartis Investigative Site

Taiyuan, Shanxi, China

Site Status

Novartis Investigative Site

Ürümqi, Xinjiang, China

Site Status

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Guangzhou, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shenzhen, , China

Site Status

Novartis Investigative Site

Tianjin, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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COMB157G2402

Identifier Type: -

Identifier Source: org_study_id