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New hope for teens with MS: drug trial aims to cut relapses

NCT ID NCT03958877

Disease control Sponsor: Biogen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a drug called BIIB017 (Plegridy) in teenagers aged 10 to 17 with relapsing-remitting multiple sclerosis (MS). It compares Plegridy to another MS drug, Avonex, to see which is safer and more effective at reducing relapses. The trial involves 152 participants and includes a long-term follow-up to monitor side effects and disease outcomes.

What this could mean

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

Active substance
Peginterferon beta-1a (Plegridy)
What this could lead to
If successful, this could provide a new treatment option for teenagers with relapsing-remitting MS, potentially reducing relapses and slowing disease progression.
What could go wrong
This is an early-stage Phase 3 trial with only 152 participants, so results may not apply to all patients. Side effects from interferons can include flu-like symptoms and injection site reactions.

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

152 people

The number who actually took part.

Started

Oct 2019

Expected to finish

May 2027

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 18 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.

Key Inclusion Criteria: Part 1: * Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS. * Must have an EDSS score between 0.0 and 5.5. * Must have experienced \>= 1 relapse in the 12 months prior to randomization (Day 1) or \>= 2 relapses in the 24 months prior to randomization (Day 1) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1). Part 2: • Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol. Key Exclusion Criteria: Part 1: * Primary progressive, secondary progressive, or progressive relapsing MS. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing participants by the lack of clinically stable periods or clinical improvement. * History of severe allergic or anaphylactic reactions or known drug hypersensitivity. * Known allergy to any component of Avonex or BIIB017 formulation. * Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the participant has not stabilized from a previous relapse prior to randomization (Day 1). * Any previous treatment with PEGylated human IFN β-1a. Part 2: * Any significant changes in medical history occurring after enrollment in Part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the participant's participation in Part 1. The Investigator must re-assess the participant's medical fitness for participation and consider any factors that would preclude treatment. * The participant could not tolerate BIIB017 in Part 1. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis, relapsing-remitting

Contacts and locations

Locations

  • Akdeniz University Medical Faculty

    Antalya, 07059, Turkey (Türkiye)

  • Azienda Ospedaliera Universitaria 'Federico II'

    Naples, 80131, Italy

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

    Naples, 80138, Italy

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Florence, 50139, Italy

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, Bas Rhin, 67098, France

  • Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

    Porto, 4099-001, Portugal

  • Centro Hospitalar e Universitário Lisboa Norte E.P.E.

    Lisbon, Lisbon District, 1649-035, Portugal

  • Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico

    Coimbra, 3000-602, Portugal

  • Charité - Campus Virchow-Klinikum

    Berlin, 13353, Germany

  • Children's Hospital Zagreb

    Zagreb, 10000, Croatia

  • Clinic of Neurology and Psychiatry for Children and Youth

    Belgrade, Balkans, 11000, Serbia

  • Clinical Hospital Center 'Sestre Milosrdnice'

    Zagreb, 10000, Croatia

  • Clinique CHC MontLégia

    Liège, Wallonia, 4000, Belgium

  • Debreceni Egyetem

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • FSBI "Federal Siberian Scientific-Clinical Center of FMBA"

    Krasnoyarsk, Krasnoyarsk Krai, 660037, Russia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50333, Czechia

  • Gazi University Medical Faculty Clinical Research Unit

    Ankara, 06500, Turkey (Türkiye)

  • General Hospital of Larissa

    Larissa, Thessaly, 41110, Greece

  • General Hospital of Thessaloniki 'Hippokration'

    Thessaloniki, 54642, Greece

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, Levant, 9112001, Israel

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295, France

  • Hopital Purpan

    Toulouse, Haute Garonne, 31059, France

  • Hopital Razi

    Manouba, Mannouba, 2010, Tunisia

  • Hopital Roger Salengro - CHU Lille

    Lille, Nord, 59037, France

  • Hospital Beatriz Ângelo

    Loures, Lisbon District, 2674-514, Portugal

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1199, Argentina

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14011, Spain

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital de Braga

    Braga, Minho, 4710-243, Portugal

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, Val De Marne, 94275, France

  • Hôpital Fattouma Bourghiba

    Monastir, 5000, Tunisia

  • Hôpital Habib Bourguiba

    Sfax, 3029, Tunisia

  • Ibn Sina Hospital

    Ash Shuwaykh, Shuwaikh, 12345, Kuwait

  • Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

    Izmir, 35210, Turkey (Türkiye)

  • King Faisal Specialist Hospital & Research Center

    Jeddah, Mecca Region, 40047, Saudi Arabia

  • King Saud University

    Riyadh, 11461, Saudi Arabia

  • LLC National center for socially significan disease

    Saint Petersburg, Sankt-Peterburg, 197110, Russia

  • MHATNP 'Sv.Naum', EAD

    Sofia, 1113, Bulgaria

  • Meridian Clinical Research

    Norfolk, Virginia, 23502, United States

  • Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic''

    Belgrade, Balkans, 11070, Serbia

  • Narodny ustav detskych chorob

    Bratislava, 83340, Slovakia

  • Nebbiolo LLC

    Tomsk, Oblast, 634009, Russia

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139, Turkey (Türkiye)

  • Pecsi Tudomanyegyetem KK

    Pécs, Baranya, 7623, Hungary

  • RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'

    Belgorod, 308007, Russia

  • Royal Children's Hospital

    Parkville, Victoria, 3052, Australia

  • SAIH 'Kemerovo Regional Clinical Hospital'

    Kemerovo, Siberia, 650066, Russia

  • SBEI HPE 'Bashkir State Medical University' of the MoH of the RF

    Ufa, Bashkortostan Republic, 450077, Russia

  • SBEI HPE 'Rostov State Medical University' of the MoH of the RF

    Rostov-on-Don, 344022, Russia

  • SBHI

    Moscow, 119602, Russia

  • SBIH of Moscow region "Moscow Regional Scientific & Research

    Moscow, 129110, Russia

  • Schneider Children's Medical Center

    Petach-Tikva, Tel Aviv, 4920235, Israel

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • St. Josef-Hospital Universitaetsklinikum

    Bochum, North Rhine-Westphalia, 44791, Germany

  • State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'

    Yaroslavl, 150000, Russia

  • UC San Diego Health

    La Jolla, California, 92024, United States

  • UNC Hospitals

    Chapel Hill, North Carolina, 27514, United States

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075, Germany

  • Universitair Ziekenhuis Ghent

    Ghent, East Flanders, 9000, Belgium

  • University Children Hospital

    Belgrade, Balkans, 11000, Serbia

  • University Hospital Centre Split

    Split, Dalmatia, 21000, Croatia

  • University Hospital Centre Zagreb

    Zagreb, 10000, Croatia

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Other studies related to the condition(s) this trial covers.