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

An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis

Phase 2 Interventional Hoffmann-La Roche · NCT07161258

This study will test fenebrutinib in children and adolescents ages 10 to under 18 with relapsing multiple sclerosis to measure how the drug behaves in the body and whether it is safe and well tolerated.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment12 (estimated)
Ages10 Years to 17 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsfenebrutinib
Locations17 sites (Rosario, Santa Fe Province and 16 other locations)
Trial IDNCT07161258 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 10 to under 18 with relapsing MS (recent relapses or MRI activity), EDSS 0–5.5, and up-to-date childhood vaccinations.

Not a fit: Patients with primary progressive MS or non-active secondary progressive MS, significant comorbid medical or psychiatric illness, a history of cancer or organ transplant, or who do not meet the age or disability criteria are unlikely to benefit.

Why it matters

Potential benefit: If successful, the trial could define safe pediatric dosing and support a new oral treatment option for children and teens with relapsing MS.

How similar studies have performed: BTK inhibitors such as fenebrutinib have shown promise in adult MS trials, but pediatric use is largely untested and pediatric data are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Rosario, Santa Fe Province and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing Multiple SclerosisPediatric multiple sclerosisPediatric MSChildren MSChildren multiple sclerosisAdolescent multiple sclerosisPediatric fenebrutinib
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.