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Relapsing Multiple SclerosisPhase 4NCT05199571

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

A Phase 4 study testing Ofatumumab in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Ofatumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
18 sitesChina
Study dates
22 Jul 2022to 13 Feb 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Novartis Investigative Site

    Beijing, 065001

  • Novartis Investigative Site

    Beijing, 100034

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630

  • Novartis Investigative Site

    Guangzhou, 510260

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150001

  • Novartis Investigative Site

    Lanzhou, Gansu, 730030

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Shenyang, Liaoning, 110011

  • Novartis Investigative Site

    Shenzhen, 518036

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050000

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830054

  • Novartis Investigative Site

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: 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

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.

Read the detailed 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.

Being tested
Ofatumumab
Keywords
Relapsing multiple sclerosis, open-label, interventional, efficacy and safety, ofatumumab, China, adult, OMB157

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabBiological

    Also called OMB157

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

Study groups in NCT05199571
Study groupRoleWhat they receive
OfatumumabExperimentalOfatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
Receives: Biological: Ofatumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline up to approximately 12 months

Secondary outcomes (5)

  1. Number of Adverse Events and Serious Adverse Events

    Adverse events and SAEs, including clinically significant laboratory data and vital signs which meet the definition of adverse events

    Measured: Baseline to safety cut-off up to approximately 15.2 months

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

    Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per participant) as the response variable. The model includes baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans is used as the offset.

    MRI scans were performed at screening, month 3 and 12 (end of study) and end of follow up for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement.

    Measured: Baseline up to approximately 12 months

  3. Annualized Rate of New or Enlarging T2 Lesions

    Obtained from fitting a negative binomial regression model with log link function, the total number of new or enlarged T2 lesions (relative to baseline/month 3 scan) during the Month 3/treatment period (per participant) as the response variable. Natural log of time from screening scan in years is used as the offset. The model will include baseline age and baseline volume of T2 lesions as continuous covariates.

    Measured: Baseline up to approximately 12 months

  4. Change in T2 Lesion Volume Relative to Baseline

    T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value

    Measured: Baseline up to approximately 12 months

  5. Percentage Change in T2 Lesion Volume Relative to Baseline

    T2 lesion volume as measured by MRI and percent change calculated as post baseline value - baseline value divided by baseline value multiplied by 100.

    Measured: Baseline up to approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start22 Jul 2022
  3. Primary completion13 Feb 2025
  4. Study completion13 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05199571
Sponsor's protocol ID
COMB157G2402
Status last verified
Dec 2025
First submitted
6 Jan 2022
Last updated
13 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ofatumumab in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Annualized Relapse Rate (ARR) Based on Confirmed Relapses (time frame: Baseline up to approximately 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05199571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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