Pharmacokinetics and Pharmacodynamics of Ublituximab in Pediatric Relapsing Multiple Sclerosis
A study is planned to evaluate the pharmacokinetics and pharmacodynamics of ublituximab in patients aged 10 to less than 18 years with relapsing multiple sclerosis (RMS). It will assess non-inferiority of ublituximab compared to fingolimod in participants weighing 25 to 40 kg, along with long-term safety and efficacy during an extension phase.
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Why it matters
This research is important as it focuses on a new treatment for pediatric RMS, which has limited options available. Understanding ublituximab's profile in this population could influence future care.
What this does not prove
No results have been posted yet, and the study's planned enrolment and endpoints do not constitute findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (6)
subjects"Relapsing Multiple Sclerosis"
controlled"briefSummary": "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).
intervention"measure": "Part A and B: Percentage of Participants with Treatment-emergent Anti-drug Antibodies (ADAs) to Ublituximab",
primary endpointPart A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab
findings"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)."
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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