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New oral drug trial aims to tame MS in kids

NCT ID NCT07161258

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study tests an oral drug called fenebrutinib in 12 children and adolescents aged 10 to 17 with relapsing multiple sclerosis. The goal is to see how the drug moves through the body, how safe it is, and whether it reduces new brain lesions seen on MRI. Participants can choose to continue the drug in an optional extension period after the initial dose exploration.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fenebrutinib (an oral drug that targets the immune system)
What this could lead to
If it works, this could provide a new treatment option for children and teens with relapsing multiple sclerosis, potentially reducing relapses and brain lesions.
What could go wrong
This is a small, early-phase study with only 12 participants, so results may not apply to everyone. The drug may cause side effects or not work as well as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centro Clnico Acadmico - Braga, Associao (2CA-Braga)

    RECRUITING

    Braga, 4710-243, Portugal

  • Centro de Pesquisas Clinicas - CPCLIN

    RECRUITING

    São Paulo, São Paulo, 01228-200, Brazil

  • Clinstile S.A de C.V.

    RECRUITING

    Mexico City, Mexico CITY (federal District), 06700, Mexico

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario de La Princesa

    RECRUITING

    Madrid, 28006, Spain

  • INECO Neurociencias Orono

    RECRUITING

    Rosario, Santa Fe Province, S2000DTB, Argentina

  • Instituto de Neurologia de Curitiba - Hospital Ecoville

    RECRUITING

    Curitiba, Paraná, 81210-310, Brazil

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    RECRUITING

    Warsaw, 04-730, Poland

  • L2IP ?Instituto de Pesquisas Clínicas Ltda.

    RECRUITING

    Brasília, Federal District, 70200-730, Brazil

  • Neurociencias Estudios Clinicos S.C.

    RECRUITING

    Culiacán, Sinaloa, 80020, Mexico

  • Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Sanatorio del Sur S.A.

    RECRUITING

    San Miguel de Tucumán, T4000IDK, Argentina

  • UH of State NPC Danulo Halytsky NMU in Lviv CID, Clinic of Neurology and Neurosurgery

    RECRUITING

    Lviv, 79010, Ukraine

  • Unidade Local de Saude de Coimbra E P E

    RECRUITING

    Coimbra, 3000-602, Portugal

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, 60-355, Poland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80 952, Poland

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