Trials / Recruiting
RecruitingNCT07161258
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fenebrutinib | Fenebrutinib will be administered orally. |
Timeline
- Start date
- 2025-10-06
- Primary completion
- 2027-06-08
- Completion
- 2029-02-13
- First posted
- 2025-09-08
- Last updated
- 2026-04-13
Locations
17 sites across 7 countries: Argentina, Brazil, Mexico, Poland, Portugal, Spain, Ukraine
Source: ClinicalTrials.gov record NCT07161258. Inclusion in this directory is not an endorsement.