Relapsing-remitting Multiple Sclerosis MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ponesimod
CAS Number: 854107-55-4
Current Sponsor code: JNJ-67896153
Other de
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate that ponesimod is not less effective than fingolimod in reducing relapses in pediatric participants with relapsing remitting multiple sclerosis (RRMS) if treatment is taken as directed through Week 108;Secondary Objective: ? To assess whether ponesimod and fingolimod independently achieve an ARR of <0.3 ? To assess the effect of ponesimod on MS disability accumulation and magnetic resonance imaging (MRI) lesion accrual in comparison with fingolimod in pediatric participants with RRMS ?To evaluate the safety, tolerability, and pharmacodynamics (PD) of ponesimod in comparison with fingolimod in pediatric participants with RRMS ?To evaluate the pharmacokinetics (PK) of ponesimod in pediatric participants with RRMS ?To study the PK/PD relationship for key efficacy and safety outcomes in pediatric participants with RRMS treated with ponesimod;Primary end point(s): Annualized relapse rate (ARR), defined as the number of confirmed relapses per participant-year through Week 108;Timepoint(s) of evaluation of this end point: From Randomization to Week 108 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. ARR 2. Disability: - Time to 12- and 24-week confirmed disability accumulation as measured by Expanded Disability Status Scale (EDSS) score 3. MRI: - Annualized rate of new/newly enlarging T2 lesions - Cumulative number of new/newly enlarging T2 lesions from baseline to Week 108 - Proportion of participants free of new/newly enlarging T2 lesions at End of Treatment (EOT) and by visit (ie, Week 24, 48 and 108) 3. Safety / tolerability - Adverse events (AEs), including AEs of special interest (AESI) - Electrocardiogram (ECG) parameters, including heart rate (HR), intervals for PR, QRS, QT, and QTcF - Pulmonary function test (PFT), including forced expiratory volume in 1 second (FEV1), and forced vital capacity (FVC) - Blood pressure - Laboratory values, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin - Change in body weight/height from Baseline to End of Study (EOS) - Suicidality assessment using the Columbia-Suicide Severity Rating Scale (C-SSRS) 4. Pharmacodynamics - Peripheral blood lymphocyte counts on Day 1 and at Weeks 4 and 12 5. Pharmacokinetics - PK sub-study: Population PK parameters (AUC, Cmax, Tmax, t1/2) - Main study: Population PK parameters, such as AUC and Cmax (if data allow);Timepoint(s) of evaluation of this end point: At timepoints as specified within the protocol | — |
Countries
Belgium, Bulgaria, Czechia, Czech Republic, France, Germany, Hungary, Italy, Poland, Portugal, Spain, Sweden, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed