Health Trials

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

ConditionRelapsing Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-17
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)

Potentially confounding neurological, somatic, or metabolic disorders

Current clinically significant psychiatric or medical illness

History of cancer, transplants, or bleeding disorders

Trial design

Design model

Single group

Treatments tested in this trial

  • Fenebrutinib

    Drug

    Fenebrutinib will be administered orally.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: FenebrutinibExperimental treatment 1 intervention

Trial outcomes

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)

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
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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