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New hope for kids with rare muscle disease: Long-Term drug safety trial begins

NCT ID NCT06435312

Disease control Sponsor: UCB Biopharma SRL 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study looks at the long-term safety of a daily injection called zilucoplan in children with a rare muscle-weakening disease called generalized myasthenia gravis. It includes up to 8 children who have already completed a previous study. The goal is to see if the drug remains safe and tolerable over an additional 52 weeks.

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

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Nov 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

12 years and older

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: United States of America (USA) specific inclusion criterion: \- Participant must be ≥ 12 years of age at the time of signing the Informed Consent/Assent according to local regulation. Rest of World (ROW) specific inclusion criterion: \- Participant must be ≥ 2 years of age at the time of signing the Informed Consent/Assent according to local regulation. Global specific inclusion criteria: * Participant has completed the MG0014 according to the protocol, and further treatment with zilucoplan is in the interest of the participant in the investigator´s opinion * Participant agrees to receive booster vaccinations against meningococcal infections during the study, if clinically indicated according to the local standard of care Exclusion Criteria: * Study participant met any mandatory investigational medicinal product (IMP) withdrawal or mandatory permanent discontinuation criteria in MG0014 or permanently discontinued IMP * Participant has known positive serology for muscle-specific kinase * Participant has known hypersensitivity to any components of the IMP * Participant has a prior history of meningococcal disease

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

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

Generalized myasthenia gravis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mg0015 20220

    Seoul, South Korea

  • Mg0015 40144

    Milan, Italy

  • Mg0015 40218

    Warsaw, Poland

  • Mg0015 40735

    Glasgow, United Kingdom

  • Mg0015 40736

    London, United Kingdom

  • Mg0015 40774

    Katowice, Poland

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