Relapsing Multiple Sclerosis (RMS)
Conditions
Interventions
None listed
Sponsors
Merck Healthcare KGaA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years to 55 years female and male participants - Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018) - Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization - Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score
Exclusion criteria
Exclusion criteria: - Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b) Participants with secondary progressive MS without evidence of relapse. - Disease duration more than (>) 10 years in participants with an EDSS =
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ARR based on qualified relapses at Week 96 in participants with RMS | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Time to first occurrence of 12-week confirmed disability progression (CDP) as measured by the Expanded Disability Status Scale (EDSS) over 96 weeks b.Time to first occurrence of 24-week CDP as measured by EDSS over 96 weeks c.Change from Baseline (CFB) in Patient Reported Outcomes Measurement Information System [PROMIS] PF score at 96 weeks d.CFB in PROMIS Fatigue score at 96 weeks e.Total number of T1 Gd+ lesions based on assessments at Week 24, Week 48, and Week 96. f. Total number of new or enlarging T2 lesions based on assessments at Week 24, Week 48, and Week 96 g.Safety as assessed by the nature, severity, and occurrence of adverse events (AEs) and adverse events of special interest (AESIs); vital signs; electrocardiograms (ECGs); absolute concentrations and change from Baseline in immunoglobulin (Ig) levels; and clinical laboratory safety parameters up to Week 108 h. OLE period: *Efficacy and HRQoL endpoints at Weeks 48, 96, and 144 oARR, based on protocol-defined qualified relapses oChange from Baseline in PROMIS PF score oChange from Baseline in PROMIS fatigue score oChange from Baseline in Medical Outcomes Study 36 Item Short Form Health Survey (SF-36v2) *Efficacy and HRQoL endpoints over 144 weeks oTime to first occurrence of 12-week confirmed EDSS progression over 144 weeks oTime to first occurrence of 24-week confirmed EDSS progression over 144 weeks oTime to first occurrence of 12-week confirmed PF deterioration compared to Baseline over 144 weeks *Efficacy endpoints at Weeks 24, 48, 96, and 144 oTotal number of new or enlarging T2 lesions oTotal number of T1 Gd+ lesions *Safety as assessed by the nature, severity, and occurrence of AEs and AESIs; vital signs; ECGs; absolute concentrations and change from Baseline in Ig levels; clinical laboratory safety parameters up to Week 144 * Changes in fluid biomarker levels between treatment groups * Correlations between levels in fluid biomarkers, gene expression and MRI c | — |
Countries
Netherlands
Outcome results
None listed