An Open-Label, Single-Arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents with Relapsing Multiple Sclerosis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519800-28-00

Acronym

CN45847

Enrollment

Registered

2025-06-24

Start date

2025-11-26

Completion date

Unknown

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis

Brief summary

Plasma concentration of fenebrutinib at specified time points, Total number of new T1 gadolinium−enhancing lesions observed on brain MRI scans at Week 12

Detailed description

Occurrence and severity of adverse events, with severity determined according to NCI CTCAE v5.0, Change from baseline in vital signs, Change from baseline in ECG parameters, Change from baseline in clinical laboratory test results, Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale

Interventions

DRUGFenebrutinib

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Plasma concentration of fenebrutinib at specified time points, Total number of new T1 gadolinium−enhancing lesions observed on brain MRI scans at Week 12	—

Secondary

Measure	Time frame
Occurrence and severity of adverse events, with severity determined according to NCI CTCAE v5.0, Change from baseline in vital signs, Change from baseline in ECG parameters, Change from baseline in clinical laboratory test results, Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale	—

Countries

France, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026