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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Fenebrutinib will be administered orally.
INECO Neurociencias Orono
Rosario, Santa Fe Province, Argentina
RECRUITINGSanatorio del Sur S.A.
San Miguel de Tucumán, Argentina
RECRUITINGL2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
RECRUITINGInstituto de Neurologia de Curitiba - Hospital Ecoville
Curitiba, Paraná, Brazil
RECRUITINGNucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGCentro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo, Brazil
RECRUITINGClinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico
RECRUITINGNeurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, Mexico
RECRUITINGUniwersyteckie Centrum Kliniczne
Gdansk, Poland
RECRUITINGUniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
RECRUITING...and 7 more locations
Plasma Concentration of Fenebrutinib
Time frame: Up to Week 96
Total Number of New T1 Gadolinium (Gd)-enhancing Lesions on Brain Observed Through Magnetic Resonance Imaging (MRI) Scans
Time frame: At Week 12
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 100 weeks
Percentage of Participants With Suicidal Ideation (SI) or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Time frame: Up to approximately 100 weeks
Change From Baseline in Vital Signs - Pulse Rate
Time frame: Baseline up to approximately 100 Weeks
Change From Baseline in Vital Signs - Blood Pressure
Time frame: Baseline up to approximately 100 Weeks
Change From Baseline in Single 12-lead Electrocardiogram (ECG) Parameter - QTc Interval
Time frame: Baseline up to approximately 100 Weeks
Change From Baseline in Single 12-lead ECG Parameter - PR Interval
Time frame: Baseline up to approximately 100 Weeks
Change from Baseline in Clinical Laboratory Test Results - Alanine Aminotransferase (ALT)
Time frame: Baseline up to approximately 100 Weeks
Change from Baseline in Clinical Laboratory Test Results - Aspartate Aminotransferase (AST)
Time frame: Baseline up to approximately 100 Weeks
Reference Study ID Number: CN45847 https://forpatients.roche.com/
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.