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

NCT05199571 | Completed Phase 4 Results

• 1 other identifier: COMB157G2402
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Relapsing Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adjusted Annualized Relapse Rate (ARR) Based on Confirmed Relapses

  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). Adjusted ARR was obtained from fitting a negative binomial regression model adjusted for number of relapses in the previous year, baseline number of T1 Gd-enhancing lesions and baseline age as continuous covariates (offset: Natural log of time in study in years).

  Baseline up to approximately 12 months

Secondary Outcomes (5)

• Number of Adverse Events and Serious Adverse Events

  Baseline to safety cut-off up to approximately 15.2 months

• Number of Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan

  Baseline up to approximately 12 months

• Annualized Rate of New or Enlarging T2 Lesions

  Baseline up to approximately 12 months

• Change in T2 Lesion Volume Relative to Baseline

  Baseline up to approximately 12 months

• Percentage Change in T2 Lesion Volume Relative to Baseline

  Baseline up to approximately 12 months

Other Outcomes (2)

• Participant Based Annualized Relapse Rate (ARR)

  Baseline up to approximately 12 months

• Time Based Annualized Relapse Rate (ARR)

  Baseline up to approximately 12 months

Study Arms (1)

Ofatumumab

EXPERIMENTAL

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

Biological: Ofatumumab

Interventions

Ofatumumab BIOLOGICAL

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

Also known as: OMB157

Ofatumumab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

Novartis Investigative Site

Lanzhou, Gansu, 730030, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510000, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510080, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510630, China

Location

Novartis Investigative Site

Shijiazhuang, Hebei, 050000, China

Location

Novartis Investigative Site

Harbin, Heilongjiang, 150001, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430030, China

Location

Novartis Investigative Site

Suzhou, Jiangsu, 215004, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110011, China

Location

Novartis Investigative Site

Taiyuan, Shanxi, 030001, China

Location

Novartis Investigative Site

Ürümqi, Xinjiang, 830054, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310006, China

Location

Novartis Investigative Site

Beijing, 065001, China

Location

Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Guangzhou, 510260, China

Location

Novartis Investigative Site

Shanghai, 200025, China

Location

Novartis Investigative Site

Shenzhen, 518036, China

Location

Novartis Investigative Site

Tianjin, 300052, China

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Interventions

ofatumumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: July 22, 2022
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: January 13, 2026
• Results First Posted: November 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (18)