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New hope for kids with MS: drug showdown begins

NCT ID NCT04926818

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two newer multiple sclerosis drugs, ofatumumab and siponimod, against an older one, fingolimod, in 129 children aged 10 to 17. The goal is to see if the newer drugs are at least as good at preventing MS relapses. Participants take one of the three drugs for two years, and researchers track how many relapses occur.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ofatumumab, Siponimod, and Fingolimod (drugs to control MS relapses)
What this could lead to
If successful, this could show that newer drugs like ofatumumab or siponimod work as well as or better than fingolimod for children with MS, offering more options to control relapses.
What could go wrong
This is a non-inferiority trial, meaning it aims to show the new drugs are not worse than the standard, not necessarily better. Results may not apply to all MS types, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

129 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: 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

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Conditions

The condition(s) this trial relates to.

multiple sclerosis Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis (MS)

Contacts and locations

Locations

  • Arkansas Childrens Hosp Rsch Inst

    Little Rock, Arkansas, 72202, United States

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609, United States

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104 4399, United States

  • Childrens National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    Parkville, Victoria, 3052, Australia

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Esneux, 4130, Belgium

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    Curitiba, Paraná, 81210-310, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000, Brazil

  • Novartis Investigative Site

    Montreal, Quebec, H3A 2B4, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1C5, Canada

  • Novartis Investigative Site

    Lo Barnechea, Santiago Metropolitan, 7691236, Chile

  • Novartis Investigative Site

    Zagreb, 10000, Croatia

  • Novartis Investigative Site

    Tallinn, 11315, Estonia

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275, France

  • Novartis Investigative Site

    Montpellier, 34090, France

  • Novartis Investigative Site

    Strasbourg, 67000, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Bochum, 44791, Germany

  • Novartis Investigative Site

    Guatemala City, 01015, Guatemala

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110017, India

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226014, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700017, India

  • Novartis Investigative Site

    Petah Tikva, 4920235, Israel

  • Novartis Investigative Site

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Riga, LV-1004, Latvia

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700, Mexico

  • Novartis Investigative Site

    Mexico City, Mexico City, 06720, Mexico

  • Novartis Investigative Site

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    Lodz, 93-338, Poland

  • Novartis Investigative Site

    Poznan, 60-355, Poland

  • Novartis Investigative Site

    Warsaw, 04-730, Poland

  • Novartis Investigative Site

    Coimbra, 3000-602, Portugal

  • Novartis Investigative Site

    Lisbon, 1169-050, Portugal

  • Novartis Investigative Site

    Belgrade, 11000, Serbia

  • Novartis Investigative Site

    Bratislava, 833 40, Slovakia

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903, Spain

  • Novartis Investigative Site

    Seville, 41009, Spain

  • Novartis Investigative Site

    Tainan, 704302, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, Karsiyaka, 35575, Turkey (Türkiye)

  • Novartis Investigative Site

    Kocaeli, 41380, Turkey (Türkiye)

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