drugset / Trial / NCT04926818

Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

NCT04926818

Phase 3 Active not recruiting 129 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

Timeline

Start
2021-10-05
Primary completion
2026-03-25
Completion
2031-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject BAF312 Unknown 0.5 mg Oral
Subject BAF312 Unknown 1 mg Oral
Subject BAF312 Unknown 2 mg Oral
Comparator Fingolimod Small molecule 0.25 mg Oral
Comparator Fingolimod Small molecule 0.5 mg Oral
Subject Ofatumumab Monoclonal antibody 20 mg Subcutaneous

Indications