Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT07161258
Eligibility Criteria:
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
* Peripheral venous access that precludes venous blood sampling as required per study protocol
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT07161258
Study Brief:
Protocol Section:
NCT07161258