A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 | Lviv | Ukraine | Recruiting |
More Hoffmann-La Roche trials in Poland
Other trials for the same condition
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.
View NCT07161258 on ClinicalTrials.gov ↗ ← All trials in Poland