Relapsing Multiple Sclerosis
Conditions
Keywords
Pediatric multiple sclerosis, Pediatric MS, Children MS, Children multiple sclerosis, Adolescent multiple sclerosis, Pediatric fenebrutinib
Brief summary
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. This study consists of a Dose Exploration Period and an Optional Extension Period. Eligible participants may choose to continue treatment with fenebrutinib in the optional extension period after completing the dose exploration period.
Interventions
DRUGFenebrutinib
Fenebrutinib will be administered orally.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of RMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, and the revised 2017 McDonald Criteria and one or more of the following: at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 month * Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive * Children and adolescents must have received all childhood vaccinations as per local/national recommendations for childhood vaccination against infectious diseases
Exclusion criteria
* A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS) * Co-morbid Conditions: * Potentially confounding neurological, somatic, or metabolic disorders * Current clinically significant psychiatric or medical illness * History of cancer, transplants, or bleeding disorders * Inability to complete an MRI scan or get gadolinium * Abnormal liver function tests or blood counts * Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets * Active, recurrent, or chronic infections * Recent or anticipated use of prohibited medications/treatments: * Certain disease-modifying therapy (DMT) and other immunosuppressants * Drugs interacting with fenebrutinib (Cytochrome P450 3A4 \[CYP3A4\] inhibitors) * Any other investigational therapy, anticoagulants, certain vaccines * A score of 4 or 5 on the "last 6 months" section of the screening SI section or "yes" on any item of the "last 6 months" Suicidal Behavior (SB) section of the C-SSRS or a positive answer on Question 9 of the Patient Health Questionnaire-9 Modified for Adolecents (PHQ-A) or significant risk of suicide, in the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Concentration of Fenebrutinib | Up to Week 96 |
| Total Number of New T1 Gadolinium (Gd)-enhancing Lesions on Brain Observed Through Magnetic Resonance Imaging (MRI) Scans | At Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately 100 weeks | — |
| Percentage of Participants With Suicidal Ideation (SI) or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to approximately 100 weeks | The C-SSRS is an interview-based instrument used to assess baseline incidence of SI and behavior. The assessment includes yes/no (0/1) responses for 5 questions, each related to SI. |
| Change From Baseline in Vital Signs - Pulse Rate | Baseline up to approximately 100 Weeks | — |
| Change From Baseline in Vital Signs - Blood Pressure | Baseline up to approximately 100 Weeks | — |
| Change From Baseline in Single 12-lead Electrocardiogram (ECG) Parameter - QTc Interval | Baseline up to approximately 100 Weeks | — |
| Change From Baseline in Single 12-lead ECG Parameter - PR Interval | Baseline up to approximately 100 Weeks | — |
| Change from Baseline in Clinical Laboratory Test Results - Alanine Aminotransferase (ALT) | Baseline up to approximately 100 Weeks | — |
| Change from Baseline in Clinical Laboratory Test Results - Aspartate Aminotransferase (AST) | Baseline up to approximately 100 Weeks | — |
Countries
Argentina, Brazil, Mexico, Poland, Portugal, Spain, Ukraine
Contacts
CONTACTReference Study ID Number: CN45847 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed