Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects
transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough
disease.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Multiple Sclerosis
Enrollment Eligibility
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)
- 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), where all
fumarates are considered as one DMT
- Subject transitioning from either any fumarate-based RMS approved therapies, such as
dimethyl fumarate (DMF) or diroximel fumarate (DRF), 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 fumarates 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
Exclusion Criteria:
- Subjects with primary progressive MS or SPMS without disease activity
- Subjects meeting criteria for neuromyelitis optica
- 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
(e.g. subjects with known exposure to, or history of syphilis, or active or latent
tuberculosis, even if previously treated), as confirmed by medical history or per
local practice
- Subjects with active hepatitis B and C disease, assessed locally
- 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