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Phase II: Fenebrutinib in Pediatric Relapsing Multiple Sclerosis (FENerations1)

Clinical Trial Overview

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

Objective

Open label, single arm study will evaluate the pharmacokinetic (PK) and pharmacodynamic (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.

PK: Pharmacokinetics; PD: Pharmacodynamics; RMS: Relapsing Multiple Sclerosis

Primary Endpoints

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]

Secondary Endpoints

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) [Time Frame: Up to approximately 100 weeks]
- 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.
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]

Fenebrutinib (RO7010939)

Modality: Bruton’s Tyrosine Kinase Inhibitor

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Clinical Trial Overview

Inclusion and Exclusion Criteria

Enrollment and Resources

View on ClinicalTrials.gov

Inclusion and Exclusion Criteria

Key Inclusion Criteria

Key Exclusion 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 months
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

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
Peripheral venous access that precludes venous blood sampling as required per study protocol
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

Enrollment & Resources

Enrollment

For more information on eligibility criteria, view the study or reach out to our team.

Web

ClinicalTrials.gov
Identifier: NCT07161258

Phone

1-888-662-6728
(US and Canada)

Email

[email protected]

Clinical Trial Site Locations

Clinical Trial Site Locations

For more information on recruitment status, or where the study is being conducted

Visit ClinicalTrials.gov

Information is consistent with ClinicalTrials.gov as of January 15, 2026. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

Looking for more information?

Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.

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Submit a Request

Call the Trial Information Support Team: 1-888-662-6728 Hours: Monday-Friday, 5am-5pm PT

AEs
Adverse events
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
C-SSRS
Columbia-Suicide Severity Rating Scale
CYP3A4
Cytochrome P450 3A4
DMT
Disease-modifying therapy
ECG
Electrocardiogram
EDSS
Expanded Disability Status Scale
Gd
Gadolinium
IPMSSG
International Pediatric Multiple Sclerosis Study Group
MRI
Magnetic resonance imaging
MS
Multiple sclerosis
PD
Pharmacodynamic
PK
Pharmacokinetic
PPMS
Primary progressive multiple sclerosis
RMS
Relapsing multiple sclerosis
SI
Suicidal ideation
SPMS
Secondary progressive multiple sclerosis