An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab

• Register: EUCTR
• Last refreshed on: 22 April 2024
• Main ID: EUCTR2019-001341-40-BE
• Date of registration: 17/03/2020
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab
• Scientific title: A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy
• Date of first enrolment: 29/04/2020
• Target sample size: 550
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001341-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Czechia, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lebanon, Mexico, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
• Diagnosis of MS according to the 2017 Revised McDonald criteria
• Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS) (Lublin et al 2014)
• Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive)
• MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs)
• Subject transitioning from either dimethyl fumarate or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration
• Breakthrough disease activity while the participant was adequately using dimethyl fumarate or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
• Neurologically stable within one month prior to first study drug administration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Subjects with primary progressive MS (Polman et al 2011) or SPMS without disease activity (Lublin et al 2014)
• Subjects meeting criteria for neuromyelitis optica (Wingerchuk et al 2015)
• Disease duration of more than 10 years since diagnosis
• Pregnant or nursing(lactating) women
• Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication
• Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome
• Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)
• Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML
• Subjects at risk of developing or having reactivation of syphilis or tuberculosis
• Subjects at risk of developing or having reactivation of hepatitis: positive results at screening for serological markers for hepatitis A, B, C and E indicating acute or chronic infection
• Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
• Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab,
alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.)
• Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Current Sponsor code: OMB157
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: Demonstrate the effectiveness of ofatumumab 20 mg s.c. administered every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on dimethyl fumarate or fingolimod

Primary end point(s): Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks

Timepoint(s) of evaluation of this end point: 96 weeks

Secondary Objective: Evaluate the safety of ofatumumab 20 mg s.c. administrated every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on dimethyl fumarate or fingolimod

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 96 weeks

Secondary end point(s): • Proportion of subjects with adverse events, including injection related reactions
• Proportion of patients with laboratory or vital signs results meeting abnormal criteria
• The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons

Secondary ID(s)

2019-001341-40-CZ

COMB157G23101

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 29/04/2020
Contact: