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Home injection trial for myasthenia gravis shows promise

NCT ID NCT05681715

Symptom relief 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether 62 people with generalized myasthenia gravis could learn to self-administer the drug rozanolixizumab at home using a syringe driver or manual push. Participants were trained and then assessed on their ability to correctly give themselves the infusion. The goal was to see if home self-administration is feasible and safe, potentially offering more convenience for patients.

What this could mean

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

Active substance
rozanolixizumab
What this could lead to
If successful, this could allow people with generalized myasthenia gravis to conveniently administer their medication at home instead of at a clinic.
What could go wrong
This is a small, completed Phase 3 study focused on self-administration ability, not on whether the drug works better than other options. Some participants may still have difficulty or experience side effects.

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

62 people

The number who actually took part.

Started

Apr 2023

Finished

Apr 2024

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

18 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: * Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG) * Study participant is willing to perform and capable of performing home self-administration * Study participant is considered by the investigator for additional rozanolixizumab treatment with the posology proposed in this study. * Body weight ≥35 kg * Study participants may be male or female Exclusion Criteria: * Study participant has a known hypersensitivity to other anti-Fc receptor (FcRn) medications, to any components of the study medication, to any of the excipients (including polysorbate 80), or has a known history of hyperprolinemia, since both polysorbate 80 and L-proline are constituents of the rozanolixizumab formulation * Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current or history of nontuberculous mycobacterial infection (NTMBI) * Study participant has a clinically relevant active infection or a history of serious infection (resulting in hospitalization or requiring IV antibiotic treatment) within 6 weeks before the Baseline Visit * The study participant previously participated in any rozanolixizumab MG study and met any mandatory withdrawal criteria (unless the reason is directly related to MG0020 participation) or mandatory study drug discontinuation criteria. * Study participant has received a live vaccination within 4 weeks before starting treatment, or a Bacillus Calmette-Guérin (BCG) vaccine within 1 year before starting treatment; or intends to have a live vaccination during the course of the study or within 8 weeks following the last dose of rozanolixizumab * Study participant with severe (defined as Grade 3 on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis

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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

Contacts and locations

Locations

  • Mg0020 20068

    Chiba, Japan

  • Mg0020 20076

    Shinjuku-ku, Japan

  • Mg0020 20077

    Sendai, Japan

  • Mg0020 20078

    Hanamaki-shi, Japan

  • Mg0020 20161

    Tbilisi, Georgia

  • Mg0020 20165

    Tbilisi, Georgia

  • Mg0020 20305

    Tbilisi, Georgia

  • Mg0020 40140

    Göttingen, Germany

  • Mg0020 40144

    Milan, Italy

  • Mg0020 40146

    Pavia, Italy

  • Mg0020 40150

    Roma, Italy

  • Mg0020 40153

    Poznan, Poland

  • Mg0020 40155

    Gdansk, Poland

  • Mg0020 40160

    Barcelona, Spain

  • Mg0020 40163

    Oxford, United Kingdom

  • Mg0020 40168

    Nottingham, United Kingdom

  • Mg0020 40177

    Münster, Germany

  • Mg0020 40267

    Barcelona, Spain

  • Mg0020 40308

    San Sebastián de los Reyes, Spain

  • Mg0020 40727

    Lodz, Poland

  • Mg0020 40729

    Niš, Serbia

  • Mg0020 50069

    Toronto, Canada

  • Mg0020 50090

    Winston-Salem, North Carolina, 27157, United States

  • Mg0020 50092

    Orange, California, 92868, United States

  • Mg0020 50099

    San Francisco, California, 94143, United States

  • Mg0020 50560

    Edmonton, Canada

  • Mg0020 50561

    Lexington, Kentucky, 40536-0284, United States

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