Summary

Eligibility
for people ages 10-17 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by Jennifer Graves

Description

Summary

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

Official Title

A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension

Details

The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 180 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years.

Keywords

Multiple Sclerosis (MS), relapsing multiple sclerosis, pediatric, relapse, EDSS, ofatumumab, siponimod, fingolimod, RMS, MS, Multiple Sclerosis, Sclerosis, Monoclonal Antibodies, Fingolimod Hydrochloride

Eligibility

You can join if…

Open to people ages 10-17

  1. Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
  2. Diagnosis of multiple sclerosis
  3. EDSS score of 0 to 5.5, inclusive
  4. At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months

You CAN'T join if...

  1. Participants with progressive MS
  2. Participants with an active, chronic disease of the immune system other than MS
  3. Participants meeting the definition of ADEM
  4. Participants with severe cardiac disease or significant findings on the screening ECG.
  5. Participants with severe renal insufficiency

Locations

  • University of California San Diego accepting new patients
    San Diego California 92103 United States
  • Childrens Hospital Los Angeles . accepting new patients
    Los Angeles California 90027 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT04926818
Phase
Phase 3 Multiple Sclerosis Research Study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated