A study to see how fenebrutinib is processed in the body, how well it works to prevent signs of relapsing multiple sclerosis and how safe it is in children and teenagers with relapsing multiple sclerosis
- Conditions
- Relapsing Multiple Sclerosis
- Registration Number
- 2024-519800-28-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
To characterize the fenebrutinib Pharmacokinetic (PK) profile in children and adolescents To evaluate Pharmacodynamic (PD) effects of fenebrutinib in children and adolescents
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 4
Age ≥ 10 to < 18 years at the time of signing of the Informed Consent Form and at the time of fenebrutinib Initiation
A diagnosis of RMS in accordance with the IPMSSG criteria for pediatric MS, Version 2012, and the revised 2017 McDonald Criteria (Thompson et al. 2018)
Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive
Up to date on all vaccinations as per local/national recommendations
– For participants who are, or become of childbearing potential: Agreement to remain abstinent OR consistently use a barrier method (preferably external condom) and at least one highly effective contraception method – For all others: Agreement to remain abstinent OR consistently use a barrier method (preferably external condom)
Inability to complete an MRI scan, interference to MRI scan from teeth braces or other causes, or contraindication to gadolinium contrast
Presence of known or suspected neurological (other than MS), somatic, or metabolic disorders that could interfere with normal cognitive or neurological development, the diagnosis of MS, or the assessments of efficacy or safety during the study
Treatment with adrenocorticotropic hormone or systemic corticosteroid within 7 days prior to baseline MRI
Treatment with intravenous immunoglobulin (IVIg) or plasmapheresis within 4 weeks prior to fenebrutinib initiation
Previous use of fenebrutinib or another BTK inhibitor for any indication
Previous use of anti-CD20 therapies, unless CD19 B-cell count is normal at screening
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of fenebrutinib at specified time points Plasma concentration of fenebrutinib at specified time points
Total number of new T1 gadolinium−enhancing lesions observed on brain MRI scans at Week 12 Total number of new T1 gadolinium−enhancing lesions observed on brain MRI scans at Week 12
- Secondary Outcome Measures
Name Time Method Occurrence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 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 vital signs
Change from baseline in ECG parameters Change from baseline in ECG parameters
Change from baseline in clinical laboratory test results Change from baseline in clinical laboratory test results
Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale
Trial Locations
- Locations (6)
Les Hopitaux Universitaires De Strasbourg
🇫🇷Strasbourg Cedex 2, France
Hospices Civils De Lyon
🇫🇷Bron, France
Bicetre Hospital
🇫🇷Le Kremlin Bicetre Cedex, France
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Virgen De La Macarena
🇪🇸Sevilla, Spain
Hospital Universitario De La Princesa
🇪🇸Madrid, Spain
Les Hopitaux Universitaires De Strasbourg🇫🇷Strasbourg Cedex 2, FranceJérôme De SezeSite contact0388128544jerome.deseze@chru-strasbourg.fr