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Tests treatment safety and results for Relapsing Multiple Sclerosis
Official title A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
ClinicalTrials.gov ID: NCT07161258
What this study is testing
What is Fenebrutinib?
Fenebrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for relapsing multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- A diagnosis of RMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012...
- 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...
You likely can't join 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
See the full eligibility 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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Rosario, Santa Fe Province, Argentina
- San Miguel de Tucumán, Argentina
- Brasília, Federal District, Brazil
- Curitiba, Paraná, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
- Mexico City, Mexico CITY (federal District), Mexico
- Culiacán, Sinaloa, Mexico
- Gdansk, Poland
- Poznan, Poland
- Warsaw, Poland
- Braga, Portugal
- Coimbra, Portugal
- Madrid, Spain
- Seville, Spain
- Lviv, Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rosario, Santa Fe Province, Argentina; San Miguel de Tucumán, Argentina; Brasília, Federal District, Brazil; Curitiba, Paraná, Brazil; Porto Alegre, Rio Grande do Sul, Brazil; São Paulo, São Paulo, Brazil and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.