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New pill shows promise in quieting MS brain lesions

NCT ID NCT05119569

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This Phase 2 trial tests fenebrutinib, an oral drug, in 109 people with relapsing multiple sclerosis. Participants receive either the drug or a placebo for 12 weeks, and researchers measure new brain lesions on MRI scans. The goal is to see if fenebrutinib can reduce disease activity and control relapses.

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 immune cells)
What this could lead to
If successful, this could point toward a new oral treatment option to reduce brain lesions and control relapses in multiple sclerosis.
What could go wrong
This is an early Phase 2 trial with only 109 participants, so results may not hold in larger studies. The drug may not outperform existing treatments or could have side effects.

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

109 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Dec 2026

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

18 to 55 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 revised 2017 McDonald Criteria. * Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening. * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs. * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm. Exclusion Criteria: * Disease duration of \> 10 years from the onset of symptoms and an EDSS score at screening \< 2.0. * Female participants who are pregnant or breastfeeding, or intending to become pregnant. * Male participants who intend to father a child during the study. * A diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (SPMS). * Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML). * History of cancer including hematologic malignancy and solid tumors within 10 years of screening. * Presence of other neurological disorders that could interfere with the diagnosis of MS or with the assessments of safety or efficacy during the study. * Clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease. * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study. * History of alcohol or other drug abuse within 12 months prior to screening. * History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of human immunodeficiency virus (HIV) infection. * Inability to complete an MRI scan. * Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening. * Receipt of a live-attenuated vaccine within 6 weeks prior to randomization. * Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.

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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

Contacts and locations

Locations

  • Cleveland Clinic Lou Ruvo

    Las Vegas, Nevada, 89106, United States

  • Clinical Center Nis

    Niš, 18000, Serbia

  • Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • Clinical Hospital Center Rijeka - PPDS

    Rijeka, 51000, Croatia

  • Clinical Hospital Centre Zemun

    Zemun, 11080, Serbia

  • Clinical center Kragujevac

    Kragujevac, 34000, Serbia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91, Czechia

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835, United States

  • General Hospital Varazdin

    Varaždin, 42000, Croatia

  • Klinicki bolnicki centar Zagreb

    Zagreb, 10000, Croatia

  • Military Medical Academy

    Belgrade, 11040, Serbia

  • Nemocnice Jihlava, prispevkova organizace

    Jihlava, Vyso?ina, 586 33, Czechia

  • Poliklinika Solmed

    Zagreb, 10000, Croatia

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000, Bosnia and Herzegovina

  • Univerzitna nemocnica Bratislava

    Bratislava, 821 01, Slovakia

  • Vseobecna Fakultni Nemocnice V Praze - CRC - PPDS

    Prague, 128 08, Czechia

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