A Phase 2 interventional study of Fenebrutinib in Relapsing Multiple Sclerosis, sponsored by Hoffmann-La Roche. Recruiting at 17 sites in 7 countries. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 12 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive fenebrutinib orally.
Drug: Fenebrutinib
Fenebrutinib will be administered orally.
Plasma Concentration of Fenebrutinib
Time frame: Up to Week 96
Total Number of New T1 Gadolinium (Gd)-enhancing Lesions on Brain Observed Through Magnetic Resonance Imaging (MRI) Scans
Time frame: At Week 12
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 100 weeks
Percentage of Participants With Suicidal Ideation (SI) or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an interview-based instrument used to assess baseline incidence of SI and behavior. The assessment includes yes/no (0/1) responses for 5 questions, each related to SI.
Time frame: Up to approximately 100 weeks
Change From Baseline in Vital Signs - Pulse Rate
Time frame: Baseline up to approximately 100 Weeks
Change From Baseline in Vital Signs - Blood Pressure
Time frame: Baseline up to approximately 100 Weeks
Change From Baseline in Single 12-lead Electrocardiogram (ECG) Parameter - QTc Interval
Time frame: Baseline up to approximately 100 Weeks
Change From Baseline in Single 12-lead ECG Parameter - PR Interval
Time frame: Baseline up to approximately 100 Weeks
Change from Baseline in Clinical Laboratory Test Results - Alanine Aminotransferase (ALT)
Time frame: Baseline up to approximately 100 Weeks
Change from Baseline in Clinical Laboratory Test Results - Aspartate Aminotransferase (AST)
Time frame: Baseline up to approximately 100 Weeks
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 20 months after the start.
Of 43 industry-sponsored phase 2 interventional studies under Multiple Sclerosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 20 months is below that.
Counting every sponsor, half of 92 studies reached it within 36 months; a quarter within 19 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Fenebrutinib