A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple Sclerosis

Phase 1

• Conditions: Relapsing-remitting Multiple Sclerosis; MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-004431-24-PT
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-09
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

- A diagnosis of relapsing-remitting multiple sclerosis (RRMS) as defined by the 2017 revisions of the McDonald criteria. Central review of the diagnosis of pediatric multiple sclerosis (MS) will be required for all participants prior to Visit 3 (Day 1, randomization).
- Expanded Disability Status Scale (EDSS) score between 0 and 5.5 (inclusive) at Visit 1 (Screening) and Visit 2 (Baseline).
- At least 1 MS relapse during the previous year or 2 MS relapses in the previous 2 years or evidence of Gd+ lesions on MRI 6 months prior to Visit 3 (Day 1, Randomization), including MRI at Visit 1 (Screening).
- Must be otherwise healthy per investigator clinical judgement on the basis of physical examination, medical history, vital signs, laboratory tests, and electrocardiogram (ECGs) at Visit 1 (Screening). Any documented abnormalities must be consistent with pediatric MS. This determination must be recorded in participant’s source documents and initiated by Principal investigator (PI).
- Participants with body weight or body surface area between 5th and 95th percentile for age and sex. Overweight participants greater than 95th percentile and underweight participants less than 5th percentile may participate following medical clearance, but the minimum body weight required for study participation is 20 kg.

Refer protocol for all inclusion criteria.

Are the trial subjects under 18? yes
Number of subjects for this age range: 142
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Presenting with a diagnosis of MS with progressive course from onset (that is, primary progressive MS or progressive relapsing MS).

- Widespread and symmetric white matter alterations in the baseline MRI suggestive of other demyelinating disorders (example, metabolic disorders, mitochondrial disorders).

- Tested positive for aquaporin 4 (AQP4) or anti-myelin oligodendrocyte glycoprotein (MOG) antibodies at Visit 1 (Screening).

- Pregnant (defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin laboratory test), or breastfeeding, or planning to become pregnant while enrolled in this study.

- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Refer protocol for all exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified