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

Relapsing Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05199571
• Other study ID #: COMB157G2402
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 22, 2022
• Est. completion date: March 21, 2025

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: March 21, 2025
• Est. primary completion date: March 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Guang Zhou
China	Novartis Investigative Site	Guang Zhou
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Harbin	Heilongjiang
China	Novartis Investigative Site	Lanzhou	Gansu
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shenzhen
China	Novartis Investigative Site	Shijiazhuang	Hebei
China	Novartis Investigative Site	Suzhou	Jiangsu
China	Novartis Investigative Site	Taiyuan	Shanxi
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Wulumuqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline up to approximately 18 months
Secondary	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	Baseline up to approximately 18 months
Secondary	Number of gadolinium (Gd)-enhancing T1 lesions per MRI scan	Average number of Gd-enhancing T1 lesions per scan	Baseline up to approximately 18 months
Secondary	Annualized rate of new or enlarging T2 lesion	Number of new/newly enlarged T2 lesions per year.	Baseline up to approximately 18 months
Secondary	Percent change in T2 lesion volume relative to baseline	Percent change from baseline in total T2 lesion volume	Baseline up to approximately 18 months