Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

Korábbi kezelés

• Prior treatments:
  • Systemic corticosteroids (>0.1 milligrams/kilogram/day [mg/kg/day], or >5 milligrams/day [mg/day] of prednisone equivalent) or adrenocorticotropic hormone (ACTH) within 30 days prior to the screening MRI scan (note: Topical, ophthalmic, or inhaled corticosteroids are permitted).
  • High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.
  • Treatment with anti-CD20 or other B cell directed treatment at any time.
  • Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time.
  • Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):
• Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
• The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.

Más betegség

• Known presence or suspicion of other neurologic disorders that may mimic MS.

Laborértékek

• If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.
  • Note: Other protocol-specified inclusion/exclusion criteria may apply

• Diagnosis of RMS.
• EDSS at screening: 0-5.5, inclusive.
• Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1).
• Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.