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New MS drug shows promise in chinese trial

NCT ID NCT05199571

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug ofatumumab in 99 Chinese adults with relapsing multiple sclerosis (RMS). The goal was to see if monthly injections could reduce the number of relapses and monitor for side effects. Participants received the drug for 12 months, and researchers tracked relapse rates and MRI brain scans.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

99 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

Contacts and locations

Locations

  • Novartis Investigative Site

    Lanzhou, Gansu, 730030, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630, China

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050000, China

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150001, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004, China

  • Novartis Investigative Site

    Shenyang, Liaoning, 110011, China

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001, China

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830054, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006, China

  • Novartis Investigative Site

    Beijing, 065001, China

  • Novartis Investigative Site

    Beijing, 100034, China

  • Novartis Investigative Site

    Guangzhou, 510260, China

  • Novartis Investigative Site

    Shanghai, 200025, China

  • Novartis Investigative Site

    Shenzhen, 518036, China

  • Novartis Investigative Site

    Tianjin, 300052, China

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