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Relapsing Multiple SclerosisPhase 2FENerations1NCT07161258

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

A Phase 2 study testing Fenebrutinib in people with Relapsing Multiple Sclerosis, run by Hoffmann-La Roche at 17 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Fenebrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
17 sitesin 7 countries
Study dates
6 Oct 2025to 13 Feb 2029
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

17 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: CN45847 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S.)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

17 sites in 7 countries

Brazil4 sites, 4 recruiting

  • L2IP ?Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

    Recruiting

  • Instituto de Neurologia de Curitiba - Hospital Ecoville

    Curitiba, Paraná, 81210-310

    Recruiting

  • Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR

    Porto Alegre, Rio Grande do Sul, 90430-001

    Recruiting

  • Centro de Pesquisas Clinicas - CPCLIN

    São Paulo, São Paulo, 01228-200

    Recruiting

Other trials in Brazil

Poland3 sites, 3 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 952

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-355

    Recruiting

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw, 04-730

    Recruiting

Other trials in Poland

Spain3 sites, 3 recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

Other trials in Spain

Argentina2 sites, 2 recruiting

  • INECO Neurociencias Orono

    Rosario, Santa Fe Province, S2000DTB

    Recruiting

  • Sanatorio del Sur S.A.

    San Miguel de Tucumán, T4000IDK

    Recruiting

Other trials in Argentina

Mexico2 sites, 2 recruiting

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80020

    Recruiting

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District), 06700

    Recruiting

Other trials in Mexico

Portugal2 sites, 2 recruiting

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

    Braga, 4710-243

    Recruiting

  • Unidade Local de Saude de Coimbra E P E

    Coimbra, 3000-602

    Recruiting

Other trials in Portugal

Ukraine1 site, 1 recruiting

  • UH of State NPC Danulo Halytsky NMU in Lviv CID, Clinic of Neurology and Neurosurgery

    Lviv, 79010

    Recruiting

Other trials in Ukraine

About this study

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

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.

Being tested
Fenebrutinib
Keywords
Pediatric multiple sclerosis, Pediatric MS, Children MS, Children multiple sclerosis, Adolescent multiple sclerosis, Pediatric fenebrutinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FenebrutinibDrug

    Fenebrutinib will be administered orally.

Study groups in NCT07161258
Study groupRoleWhat they receive
FenebrutinibExperimentalParticipants will receive fenebrutinib orally.
Receives: Drug: Fenebrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma Concentration of Fenebrutinib

    Measured: Up to Week 96

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

    Measured: At Week 12

Secondary outcomes (8)

  1. Number of Participants With Adverse Events (AEs)

    Measured: Up to approximately 100 weeks

  2. 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.

    Measured: Up to approximately 100 weeks

  3. Change From Baseline in Vital Signs - Pulse Rate

    Measured: Baseline up to approximately 100 Weeks

  4. Change From Baseline in Vital Signs - Blood Pressure

    Measured: Baseline up to approximately 100 Weeks

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

    Measured: Baseline up to approximately 100 Weeks

  6. Change From Baseline in Single 12-lead ECG Parameter - PR Interval

    Measured: Baseline up to approximately 100 Weeks

  7. Change from Baseline in Clinical Laboratory Test Results - Alanine Aminotransferase (ALT)

    Measured: Baseline up to approximately 100 Weeks

  8. Change from Baseline in Clinical Laboratory Test Results - Aspartate Aminotransferase (AST)

    Measured: Baseline up to approximately 100 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start6 Oct 2025
  3. Primary completion8 Jun 2027 (estimated)
  4. Study completion13 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07161258
Sponsor's protocol ID
CN45847
Other IDs
2024-519800-28-00
Acronym
FENerations1
Status last verified
Oct 2026
First submitted
20 Aug 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

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