Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
Recruiting
Phase 2
Phase 3
Interventional Study
Relapsing Multiple Sclerosis
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About This Trial
The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (\<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weig…
Trial Locations
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Eligibility Criteria
Inclusion Criteria for Part A and Part B:
1. Diagnosis of RMS.
2. EDSS at screening: 0-5.5, inclusive.
3. Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1).
Inclusion Criteria for Part C:
1\. Participants must have completed Part A (Week 24 visit…
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