Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Fenebrutinib for Relapsing Multiple Sclerosis

This open label, single arm study will measure 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.

Official registry: https://clinicaltrials.gov/study/NCT07161258 · Hoffmann-La Roche · enrollment listed as 12

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Fenebrutinib. The registry lists allocation as na. This open label, single arm study will measure the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \< 18 years.

They plan to enroll about 12 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Fenebrutinib

Primary outcome (registry wording): Plasma Concentration of Fenebrutinib

Who it is for (from inclusion criteria)

  • Ages 10 Years to 17 Years
  • 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

Public study contact (from the registry)

Reference Study ID Number: CN45847 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S.)

global-roche-genentech-trials@gene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

17 listed

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NCT00794352 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

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NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital

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Phase 3: testing Best Available Therapy (BAT) for Relapsing Multiple Sclerosis

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NCT04047628 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

FAQ about this NCT record

Is NCT07161258 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07161258?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07161258?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary