Fenebrutinib for relapsing multiple sclerosis in children and adolescents (ages 10 to <18).

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm Phase 2 trial administers fenebrutinib to children and adolescents with relapsing MS to collect pharmacokinetic and pharmacodynamic data alongside safety and tolerability outcomes. The protocol includes a dose exploration period to establish appropriate pediatric dosing and an optional extension period for continued treatment. Eligible participants are 10 to under 18 years old with relapsing MS by IPMSSG and McDonald criteria and EDSS between 0 and 5.5. Study visits and MRI assessments will be conducted at participating sites in Argentina and Brazil.

Why it matters

Who can join: the full rules

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

Where it's running

• INECO Neurociencias Orono
  Rosario, Santa Fe Province, Argentina Recruiting
• Sanatorio del Sur S.A.
  San Miguel de Tucumán, Argentina Recruiting
• L2IP ?Instituto de Pesquisas Clínicas Ltda.
  Brasília, Federal District, Brazil Recruiting
• Instituto de Neurologia de Curitiba - Hospital Ecoville
  Curitiba, Paraná, Brazil Recruiting
• Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Centro de Pesquisas Clinicas - CPCLIN
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: CN45847 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S.)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.