Clinical Research Details

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Descriptive Information
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

Samia Khoury
sk88@aub.edu.lb

COMB157G23101
Recruiting

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 3  

No
Collaborators
  • Nabil El Ayoubi
Sponsors
  • Novartis
Conditions and Keywords
multiple sclerosis
multiple sclerosis ,ofatumumab
Study Design
Eligibility and IRB
Both
Min: 18
Max: 60
Yes
No

This study uses a prospective, single arm, open-label, multi-center treatment design, enrolling subjects who are transitioning from DMF or fingolimod.

The purpose of the study is to complement the ofatumumab pivotal Phase 3 program by exploring outcomes of patients transitioning from commonly used oral therapies, dimethyl fumarate (DMF) or fingolimod, to ofatumumab due to breakthrough disease (defined as relapse, Gd+, or new/enlarging T2 lesions)



  1. Adult subjects aged 18 to 60 years (inclusive) at Screening.
  2. Diagnosis of MS according to the 2017 Revised McDonald criteria
  3. Relapsing MS: relapsing forms of MS (RMS) including RMS and SPMS
  4. Disability status at Screening with an EDSS score of 0 to 4 (inclusive).
  5. MS treatment history with a maximum of 3 DMTs
  6. Subject transitioning from either fingolimod or dimethyl fumarate which was administered for a period of at least 6 months, as their last DMT before first study drug administration
  7. Breakthrough disease activity while the participant was adequately using fingolimod or dimethyl fumarate prior to transitioning as evidenced by one or more clinically reported relapses or one or more signs of MRI activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
  8. Neurologically stable within one month prior to first study drug administration
  1. Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator
  2. Subjects with PPMS or SPMS without disease activity
  3. Subjects meeting criteria for NMO
  4. Disease duration of more than 10 years since diagnosis
  5. Pregnant or nursing (lactating) women
  6. Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for at least 12 months after stopping study medication
  7. Subjects with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (Rheumatoid Arthritis, scleroderma, Sjögren's, Crohn's, ulcerative colitis) or with immunodeficiency syndrome (HIV, drug-induced immune deficiency)
  8. Subjects with active systemic bacterial, viral or fungal infections, or known to have AIDS
  9. Subjects with neurological symptoms consistent with PML or with confirmed PML
  10. Subjects at risk of developing or having reactivation of syphilis or tuberculosis, or hepatitis
  11. Have received any live or live-attenuated vaccines within 2 months prior to first study drug administration
  12. Have been treated with any of the medications within the time specified

  13. Medication

    Exclusionary if used within the timeframe specified below

    Systemic corticosteroids, adrenocorticotropic

    hormone

    30 days prior to screening MRI scan

    ·         Highly immunosuppressive/chemotherapeutic

    medications (mitoxantrone, cyclophosphamide, cladribine)

    ·         B-cell targeted therapies (e.g. rituximab, ocrelizumab)

    ·         Laquinimod

    2 years prior to first study drug administration

    ·         Mitoxantrone (with evidence of cardiotoxicity following treatment or cumulative life-time dose >60mg/m2)

    ·         Alemtuzumab

    ·         Lymphoid irradiation; bone marrow transplantation

    ·         Other strongly immunosuppressive treatments (with effects potentially lasting over 6 months)

    ·         Ofatumumab

    ·         aCD20+ monoclonal antibodies in development (e.g. ublituximab or obinutuzumab)

    Any time
  14. Use of other investigational drugs at the time of enrollment (Screening) or within the prior 30 days, or five elimination half-lives, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
  15. History of malignancy of any organ system, within the past 5 years, regardless of whether or not there is evidence of local recurrence or metastases.
  16. Any condition or treatment that may impact the safety of the subject, as defined in the protocol
  17. Any abnormal laboratory values prior to first study drug administration, as defined in the protocol
  18. Subjects with severe hypoproteinaemia e.g. in nephrotic syndrome
  19. Subjects with any neurologic/psychiatric disorders, as defined in protocol, prior to first study drug administration:
  20. History of hypersensitivity to the study drug or any of the excipients (including rare hereditary problems of galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption) or to drugs of similar chemical classes
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