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NCT Number: NCT07161258

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

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.

Recruiting

Interested in participating?

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Key information

Conditions

Relapsing Multiple Sclerosis

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

INECO Neurociencias Orono, Rosario, Santa Fe Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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 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

Exclusion criteria

  • 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

Treatment and study plan

Fenebrutinib

Drug

Fenebrutinib will be administered orally.

Primary outcomes

  1. Plasma Concentration of Fenebrutinib

    Time frame: Up to Week 96

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

    Time frame: At Week 12

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: 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)

    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.

  3. Change From Baseline in Vital Signs - Pulse Rate

    Time frame: Baseline up to approximately 100 Weeks

  4. Change From Baseline in Vital Signs - Blood Pressure

    Time frame: Baseline up to approximately 100 Weeks

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

    Time frame: Baseline up to approximately 100 Weeks

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

    Time frame: Baseline up to approximately 100 Weeks

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

    Time frame: Baseline up to approximately 100 Weeks

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

    Time frame: Baseline up to approximately 100 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

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

CONTACT

[email protected]

888-662-6728 (U.S.)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: FENerations1

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Sep 8, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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