A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Recruiting now · Phase 2
Conditions studied: Relapsing Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT07161258
- Run by
- Hoffmann-La Roche
- People needed
- 12
- Starts
- 2025-10-06
- Expected to finish
- 2029-02-13
- Last updated by the study team
- 2026-07-09
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- INECO Neurociencias Orono — Rosario, Santa Fe Province, Argentina (enrolling)
- Sanatorio del Sur S.A. — San Miguel de Tucumán, Argentina (enrolling)
- L2IP ?Instituto de Pesquisas Clínicas Ltda. — Brasília, Federal District, Brazil (enrolling)
- Instituto de Neurologia de Curitiba - Hospital Ecoville — Curitiba, Paraná, Brazil (enrolling)
- Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Centro de Pesquisas Clinicas - CPCLIN — São Paulo, São Paulo, Brazil (enrolling)
- Clinstile S.A de C.V. — Mexico City, Mexico CITY (federal District), Mexico (enrolling)
- Neurociencias Estudios Clinicos S.C. — Culiacán, Sinaloa, Mexico (enrolling)
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (enrolling)
- Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland (enrolling)
- Instytut "Pomnik - Centrum Zdrowia Dziecka" — Warsaw, Poland (enrolling)
- Centro Clnico Acadmico - Braga, Associao (2CA-Braga) — Braga, Portugal (enrolling)
- Unidade Local de Saude de Coimbra E P E — Coimbra, Portugal (enrolling)
- Hospital Universitario de La Princesa — Madrid, Spain (enrolling)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)
- Hospital Universitario Virgen Macarena — Seville, Spain (enrolling)
- UH of State NPC Danulo Halytsky NMU in Lviv CID, Clinic of Neurology and Neurosurgery — Lviv, Ukraine (enrolling)
Full record on ClinicalTrials.gov
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