Phase 2 Multiple Sclerosis Trial, Recruiting NCT07161258 Sponsor: Hoffmann-La Roche Condition: Multiple Sclerosis
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Phase 2 Multiple Sclerosis Trial, Recruiting

NCT07161258
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People diagnosed with relapsing multiple sclerosis (MS) who meet specific recognised diagnostic criteria, and who have had at least one MS relapse in the past year, or two relapses in the past two years, or at least one area of active inflammation visible on a brain scan (MRI) in the past six months
  • People whose level of physical disability, measured on a standard MS scale, falls within a moderate range at the time of screening (confirm with trial site)
  • Children and adolescents who have received all recommended childhood vaccinations as advised in their country

Who may not be able to join:

  • People diagnosed with primary progressive MS, or a non-active form of secondary progressive MS
  • People with certain other neurological, physical, or metabolic conditions that could interfere with the trial results
  • People with a significant current psychiatric or medical illness
  • People with a history of cancer, organ or tissue transplants, or bleeding disorders
  • People who are unable to undergo an MRI scan or cannot receive the contrast dye used during MRI (called gadolinium)
  • People with abnormal liver function test results or abnormal blood counts
  • People with a known sensitivity or intolerance to any ingredient in the trial medication (fenebrutinib tablets)
  • People with an active, recurring, or long-term infection
  • People currently using, or expected to use, certain other MS treatments, immune-suppressing medications, specific drugs known to interact with the trial medication, other experimental therapies, blood-thinning medications, or certain vaccines (confirm with trial site for the full list)
  • People who show certain signs of suicidal thoughts or behaviour based on standardised screening questionnaires, or who are considered by the investigating doctor to be at significant risk of suicide

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728 (U.S.)

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
6 October 2025
Est. completion
8 June 2027

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal 🇪🇸 Spain 🇺🇦 Ukraine

Primary endpoints

Plasma Concentration of Fenebrutinib; Total Number of New T1 Gadolinium (Gd)-enhancing Lesions on Brain Observed Through Magnetic Resonance Imaging (MRI) Scans

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov