A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Fenebrutinib: Fenebrutinib will be administered orally.
Study 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.
Eligibility
Sex
ALL
Min age
10 Years
Max age
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
Primary outcome measure(s)
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
Trial sites (17)
Facility
City
Region
Status
INECO Neurociencias Orono
Rosario
Santa Fe Province
Recruiting
Sanatorio del Sur S.A.
San Miguel de Tucumán
Argentina
Recruiting
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília
Federal District
Recruiting
Instituto de Neurologia de Curitiba - Hospital Ecoville
Curitiba
Paraná
Recruiting
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre
Rio Grande do Sul
Recruiting
Centro de Pesquisas Clinicas - CPCLIN
São Paulo
São Paulo
Recruiting
Clinstile S.A de C.V.
Mexico City
Mexico CITY (federal District)
Recruiting
Neurociencias Estudios Clinicos S.C.
Culiacán
Sinaloa
Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk
Poland
Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan
Poland
Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw
Poland
Recruiting
Centro Clnico Acadmico - Braga, Associao (2CA-Braga)
Braga
Portugal
Recruiting
Unidade Local de Saude de Coimbra E P E
Coimbra
Portugal
Recruiting
Hospital Universitario de La Princesa
Madrid
Spain
Recruiting
Hospital Universitario Ramon y Cajal
Madrid
Spain
Recruiting
Hospital Universitario Virgen Macarena
Seville
Spain
Recruiting
UH of State NPC Danulo Halytsky NMU in Lviv CID, Clinic of Neurology and Neurosurgery
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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