RightFit
RecruitingPhase 2 / Phase 3

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

Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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 weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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) or Part B (Week 96 visit) to be eligible for Part C. Exclusion Criteria for Part A and B: 1. Known presence or suspicion of other neurologic disorders that may mimic MS. 2. Prior treatments: 1. 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). 2. High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1. 3. Treatment with anti-CD20 or other B cell directed treatment at any time. 4. Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time. Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment): 1. Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time. 2. The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics. Exclusion Criteria for Part C: 1\. 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

Study sites (1)

UT