Clinical trial NCT05199571: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing multiple sclerosis
open-label
interventional
efficacy and safety
ofatumumab
China
adult
OMB157
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Annualized relapse rate (ARR)
timeFrame: Baseline up to approximately 18 months
Secondary outcomes:
measure: Number of adverse events and serious adverse events
timeFrame: Baseline up to approximately 18 months
measure: Number of gadolinium (Gd)-enhancing T1 lesions per MRI scan
timeFrame: Baseline up to approximately 18 months
measure: Annualized rate of new or enlarging T2 lesion
timeFrame: Baseline up to approximately 18 months
measure: Percent change in T2 lesion volume relative to baseline
timeFrame: Baseline up to approximately 18 months
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Novartis Investigative Site
state: Gansu
city: Guangzhou City
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
state: Hebei
city: Harbin
country: China
facility: Novartis Investigative Site
state: Heilongjiang
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Taiyuan
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Wulumuqi
country: China
facility: Novartis Investigative Site
state: Xinjiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Guang Zhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shenzhen
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
Study officials:
References: