A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)

Sponsor
Hoffmann-La Roche
Study ID
NCT07161258
Phase
PHASE2
Status
Recruiting
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Conditions

  • Relapsing Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Fenebrutinib — DRUG
    Fenebrutinib will be administered orally.

Study Details

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 Dates

Start date
Oct 6, 2025
Status verified
Jun 2026
Primary completion
Jun 8, 2027
Completion
Feb 13, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fenebrutinib
    Participants will receive fenebrutinib orally.

Primary Outcome Measure

Plasma Concentration of Fenebrutinib [ Time Frame: Up to Week 96 ]

Central Contacts

  • Reference Study ID Number: CN45847 https://forpatients.roche.com/
    888-662-6728 (U.S.)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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