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Research summary · 12 d ago

AI summary · not yet reviewedSubjects not reportedPhase 2Trial registry record – peer review not applicable

Phase 2 Study of Fenebrutinib in Children and Adolescents with Relapsing Multiple Sclerosis

This study is designed to evaluate the pharmacokinetics and pharmacodynamics of fenebrutinib in children and adolescents with relapsing multiple sclerosis (RMS). It plans to observe plasma concentration and MRI findings related to brain lesions in a small sample of 12 individuals aged 10 to under 18 years.

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This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.

Human efficacy: Not yet assessed
Mechanism: Not yet assessed
Evidence strength: Not yet assessed
Outcome: Not yet assessed

Why it matters

Understanding fenebrutinib's effects on RMS in younger populations is important for tailoring potential treatments, especially given the unique aspects of pediatric responses to medications.

What this does not prove

No results have been published; details about planned enrolment and study endpoints are not findings.

Next milestone

No next milestone was established from the available source.

Study facts

Study design: Interventional
Participants / samples: 12 · basis not reported
Randomised: No
Controlled: Not reported
Primary endpoint met: Not reported
Relevant MS type: Not reported
Publication date: Not reported
Evidence reviewed: Trial registry record
Regulatory approval: No
Research areas: Not classified

Original sources

Trial registrationA Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS) ↗

Supporting passages (9)

study phasePHASE2

study designINTERVENTIONAL

sample size12

randomizedNo

regulatory approvalNo

interventionFenebrutinib

primary endpoint"measure": "Total Number of New T1 Gadolinium (Gd)-enhancing Lesions on Brain Observed Through Magnetic Resonance Imaging (MRI) Scans",

findings"briefSummary": "This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \\< 18 years.\n\nThis study consists of a Dose Exploration Period and an Optional Extension Period.

limitationsPlanned enrolment and endpoints are not findings.

AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.