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

Primary Purpose

Relapsing Multiple Sclerosis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ofatumumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring Relapsing multiple sclerosis, open-label, interventional, efficacy and safety, ofatumumab, China, adult, OMB157

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ofatumumab

Arm Description

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

Outcomes

Primary Outcome Measures

Annualized relapse rate (ARR)
ARR is the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. 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). Comparisons are made to the previous rating (the last EDSS rating that does not occur during a relapse).

Secondary Outcome Measures

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
Number of gadolinium (Gd)-enhancing T1 lesions per MRI scan
Average number of Gd-enhancing T1 lesions per scan
Annualized rate of new or enlarging T2 lesion
Number of new/newly enlarged T2 lesions per year.
Percent change in T2 lesion volume relative to baseline
Percent change from baseline in total T2 lesion volume

Full Information

First Posted
January 6, 2022
Last Updated
July 13, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05199571
Brief Title
Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
August 19, 2025 (Anticipated)
Study Completion Date
August 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ofatumumab s.c. in adult participants with relapsing multiple sclerosis (RMS) in China.
Detailed Description
This study consists of three periods, Screening (up to 30 days), Treatment (12 months) and Post-treatment follow-up (6 months). It is an open-label single-arm study so all participants will receive the study drug. The first dose will be administered in the clinic and the remaining doses may be administered at home. The doses are administered at Baseline/Week 0, Week 1, Week 2, and followed by subsequent monthly dosing starting at Week 4. Participants will be 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 complete the 12-month treatment will have Post treatment Follow-Up visits at End of Study plus 3 months (EOS + 3M) and EOS + 6M, unless the participants decide to continue with commercially available ofatumumab treatment outside of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis
Keywords
Relapsing multiple sclerosis, open-label, interventional, efficacy and safety, ofatumumab, China, adult, OMB157

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ofatumumab
Arm Type
Experimental
Arm Description
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
Intervention Type
Biological
Intervention Name(s)
Ofatumumab
Intervention Description
Solution for injection in an autoinjector (pre-filled pen) containing 20 mg ofatumumab
Primary Outcome Measure Information:
Title
Annualized relapse rate (ARR)
Description
ARR is the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. 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). Comparisons are made to the previous rating (the last EDSS rating that does not occur during a relapse).
Time Frame
Baseline up to approximately 18 months
Secondary Outcome Measure Information:
Title
Number of adverse events and serious adverse events
Description
Adverse events and SAEs, including clinically significant laboratory data and vital signs which meet the definition of adverse events
Time Frame
Baseline up to approximately 18 months
Title
Number of gadolinium (Gd)-enhancing T1 lesions per MRI scan
Description
Average number of Gd-enhancing T1 lesions per scan
Time Frame
Baseline up to approximately 18 months
Title
Annualized rate of new or enlarging T2 lesion
Description
Number of new/newly enlarged T2 lesions per year.
Time Frame
Baseline up to approximately 18 months
Title
Percent change in T2 lesion volume relative to baseline
Description
Percent change from baseline in total T2 lesion volume
Time Frame
Baseline up to approximately 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Other protocol-defined inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Facility Information:
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
065001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110011
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wulumuqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guang Zhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guang Zhou
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/.

Learn more about this trial

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

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