A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)

NCT07161258 | Recruiting Phase 2

• 2 other identifiers: CN458472024-519800-28-00
• Study Type: interventional
• Target: 12
• Locations: 7 countries
• Sites: 17

Brief Summary

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.

Conditions

Relapsing Multiple Sclerosis

Keywords

Pediatric multiple sclerosis; Pediatric MS; Children MS; Children multiple sclerosis; Adolescent multiple sclerosis; Pediatric fenebrutinib

Outcome Measures

Primary Outcomes (2)

• Plasma Concentration of Fenebrutinib

  Up to Week 96

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

  At Week 12

Secondary Outcomes (8)

• Number of Participants With Adverse Events (AEs)

  Up to approximately 100 weeks

• Percentage of Participants With Suicidal Ideation (SI) or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

  Up to approximately 100 weeks

• Change From Baseline in Vital Signs - Pulse Rate

  Baseline up to approximately 100 Weeks

• Change From Baseline in Vital Signs - Blood Pressure

  Baseline up to approximately 100 Weeks

• Change From Baseline in Single 12-lead Electrocardiogram (ECG) Parameter - QTc Interval

  Baseline up to approximately 100 Weeks

Study Arms (1)

Fenebrutinib

EXPERIMENTAL

Participants will receive fenebrutinib orally.

Drug: Fenebrutinib

Interventions

Fenebrutinib DRUG

Fenebrutinib will be administered orally.

Fenebrutinib

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

INECO Neurociencias Orono

Rosario, Santa Fe Province, S2000DTB, Argentina

RECRUITING

Sanatorio del Sur S.A.

San Miguel de Tucumán, T4000IDK, Argentina

RECRUITING

L2IP ?Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, 70200-730, Brazil

RECRUITING

Instituto de Neurologia de Curitiba - Hospital Ecoville

Curitiba, Paraná, 81210-310, Brazil

RECRUITING

Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR

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

RECRUITING

Centro de Pesquisas Clinicas - CPCLIN

São Paulo, São Paulo, 01228-200, Brazil

RECRUITING

Clinstile S.A de C.V.

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

RECRUITING

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, 80020, Mexico

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 952, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-355, Poland

RECRUITING

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, 04-730, Poland

RECRUITING

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

Braga, 4710-243, Portugal

RECRUITING

Unidade Local de Saude de Coimbra E P E

Coimbra, 3000-602, Portugal

RECRUITING

Hospital Universitario de La Princesa

Madrid, 28006, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU

Lviv, KIEV Governorate, 79010, Ukraine

RECRUITING

MeSH Terms

Interventions

fenebrutinib

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CN45847 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 8, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): June 8, 2027
• Study Completion (Estimated): February 13, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

UA (1); ME (2); PT (2); ES (3); BR (4); PL (3); AR (2)