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Can a new drug offer Long-Term relief for muscle weakness?

NCT ID NCT04124965

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is investigating whether rozanolixizumab, an experimental drug given as a subcutaneous infusion, is safe and effective over the long term for adults with generalized myasthenia gravis, a chronic condition causing muscle weakness. Participants who completed a prior study may receive one of two dosing regimens. The study tracks side effects and changes in daily living abilities to see if the drug helps manage symptoms over time.

What this could mean

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

Active substance
rozanolixizumab (an experimental drug given by subcutaneous infusion)
What this could lead to
If successful, this could support rozanolixizumab as a long-term treatment option to help control symptoms of generalized myasthenia gravis.
What could go wrong
This is an extension study, so it focuses on long-term safety and may not prove the drug works better than existing treatments. Side effects are possible, and results may not apply to all patients.

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

71 people

The number who actually took part.

Started

Oct 2019

Finished

Sep 2021

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: * Participant was eligible for MG0003 \[NCT03971422\] or MGC003 at the time of enrollment into either study and the participant either completed the observation Period of MG0003 or MGC003 or required rescue therapy during the Observation Period of the lead-in studies * Body weight ≥35 kg at Visit 1 * Study participants may be male or female Exclusion Criteria: * Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, if applicable, chest X-rays (posterior anterior and lateral), and TB testing by a positive (not indeterminate) QuantiFERON®-TB Gold Plus * Participant has received a live vaccination within 8 weeks prior to the Baseline visit; or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of study medication * Study participant has experienced hypersensitivity reaction after exposure to other anti-neonatal Fc receptor (FcRn) drugs - Study participant with severe (defined as Grade 3 on the myasthenia gravis-activates of daily living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis * Participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at randomization, and could jeopardize or compromise the study participant's ability to participate in this study * Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria MG0003 \[NCT03971422\] or MGC003, or discontinued study medication in either study, with the exception of discontinuation due to a need for rescue treatment * Study participant is not considered capable of adhering to the protocol visit schedule, or medication intake according to the judgment of the Investigator * Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or had suicidal ideation since the last visit in MG0003 as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)

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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

  • Mg0004 20001

    Saint Petersburg, Russia

  • Mg0004 20027

    Moscow, Russia

  • Mg0004 20028

    Saint Petersburg, Russia

  • Mg0004 20032

    Suita, Japan

  • Mg0004 20055

    Saint Petersburg, Russia

  • Mg0004 20076

    Shinjuku-Ku, Japan

  • Mg0004 20077

    Miyagi, Japan

  • Mg0004 20078

    Hanamaki Shi, Japan

  • Mg0004 20079

    Hiroshima, Japan

  • Mg0004 20080

    Taichung, Taiwan

  • Mg0004 20081

    Taipei, Taiwan

  • Mg0004 40078

    Leipzig, Germany

  • Mg0004 40124

    Prague, Czechia

  • Mg0004 40125

    Ostrava-Poruba, Czechia

  • Mg0004 40128

    Aalborg, Denmark

  • Mg0004 40129

    Bordeaux, France

  • Mg0004 40131

    Strasbourg, France

  • Mg0004 40132

    Nice, France

  • Mg0004 40133

    Paris, France

  • Mg0004 40140

    Göttingen, Germany

  • Mg0004 40144

    Milan, Italy

  • Mg0004 40146

    Pavia, Italy

  • Mg0004 40148

    Roma, Italy

  • Mg0004 40150

    Roma, Italy

  • Mg0004 40151

    Lublin, Poland

  • Mg0004 40154

    Lodz, Poland

  • Mg0004 40155

    Gdansk, Poland

  • Mg0004 40157

    L'Hospitalet de Llobregat, Spain

  • Mg0004 40159

    Barcelona, Spain

  • Mg0004 40177

    Münster, Germany

  • Mg0004 50066

    Montreal, Canada

  • Mg0004 50069

    Toronto, Canada

  • Mg0004 50070

    Québec, Canada

  • Mg0004 50072

    Los Angeles, California, 90033, United States

  • Mg0004 50073

    Tampa, Florida, 33612, United States

  • Mg0004 50077

    New York, New York, 10021, United States

  • Mg0004 50081

    Phoenix, Arizona, 85013-4409, United States

  • Mg0004 50088

    Washington D.C., District of Columbia, 20037, United States

  • Mg0004 50090

    Winston-Salem, North Carolina, 27157, United States

  • Mg0004 50096

    Philadelphia, Pennsylvania, 19104, United States

  • Mg0004 50114

    Indianapolis, Indiana, 46202, United States

  • Mg0004 50120

    Miami, Florida, 33144, United States

  • Mg0004 50121

    Lexington, Kentucky, 40536, United States

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