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Can a new drug ease the muscle weakness of myasthenia gravis?

NCT ID NCT04650854

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 testing an investigational drug called rozanolixizumab in people with generalized myasthenia gravis, a condition that causes muscle weakness. The study aims to see if repeated treatment cycles are safe and can help improve daily functioning. Participants receive the drug as a subcutaneous infusion over several weeks. The focus is on managing symptoms and improving quality of life.

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 provide a new treatment option to help manage symptoms of generalized myasthenia gravis.
What could go wrong
This is an extension study, so it builds on earlier results. The treatment may not work for everyone, 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

165 people

The number who actually took part.

Started

Feb 2021

Finished

Jan 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 meet one of the following: 1. completed MG0003 \[NCT03971422\] 2. required rescue therapy during the Observation Period in MG0003 or 3. completed at least 6 visits in MG0004 \[NCT04124965\] * Body weight ≥35 kg at Baseline (Day 1) * Study participants may be male or female Exclusion Criteria: * Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications * Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI) * Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, or MG0004, or permanently discontinued study drug in either study * Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final 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

  • Mg0007 20001

    Saint Petersburg, Russia

  • Mg0007 20028

    Saint Petersburg, Russia

  • Mg0007 20032

    Suita, Japan

  • Mg0007 20035

    Bunkyō City, Japan

  • Mg0007 20055

    Saint Petersburg, Russia

  • Mg0007 20068

    Chiba, Japan

  • Mg0007 20070

    Shinjuku-ku, Japan

  • Mg0007 20071

    Nagasaki, Japan

  • Mg0007 20075

    Kobe, Japan

  • Mg0007 20076

    Shinjuku-ku, Japan

  • Mg0007 20077

    Sendai, Japan

  • Mg0007 20078

    Hanamaki-shi, Japan

  • Mg0007 20079

    Hiroshima, Japan

  • Mg0007 20081

    Taipei, Taiwan

  • Mg0007 20086

    Taipei, Taiwan

  • Mg0007 20160

    Tbilisi, Georgia

  • Mg0007 20161

    Tbilisi, Georgia

  • Mg0007 20163

    Tbilisi, Georgia

  • Mg0007 20164

    Tbilisi, Georgia

  • Mg0007 20165

    Tbilisi, Georgia

  • Mg0007 20169

    Novosibirsk, Russia

  • Mg0007 40078

    Leipzig, Germany

  • Mg0007 40124

    Prague, Czechia

  • Mg0007 40125

    Ostrava - Poruba, Czechia

  • Mg0007 40126

    Copenhagen, Denmark

  • Mg0007 40127

    Aarhus, Denmark

  • Mg0007 40128

    Aalborg, Denmark

  • Mg0007 40129

    Bordeaux, France

  • Mg0007 40131

    Strasbourg, France

  • Mg0007 40132

    Nice, France

  • Mg0007 40133

    Paris, France

  • Mg0007 40134

    Essen, Germany

  • Mg0007 40139

    Jena, Germany

  • Mg0007 40140

    Göttingen, Germany

  • Mg0007 40144

    Milan, Italy

  • Mg0007 40146

    Pavia, Italy

  • Mg0007 40148

    Roma, Italy

  • Mg0007 40150

    Roma, Italy

  • Mg0007 40151

    Lublin, Poland

  • Mg0007 40153

    Poznan, Poland

  • Mg0007 40154

    Lodz, Poland

  • Mg0007 40155

    Gdansk, Poland

  • Mg0007 40157

    L'Hospitalet de Llobregat, Spain

  • Mg0007 40160

    Barcelona, Spain

  • Mg0007 40177

    Münster, Germany

  • Mg0007 40283

    Bologna, Italy

  • Mg0007 40307

    Naples, Italy

  • Mg0007 40308

    San Sebastián de los Reyes, Spain

  • Mg0007 40350

    Murcia, Spain

  • Mg0007 40360

    Limoges, France

  • Mg0007 40467

    Niš, Serbia

  • Mg0007 50066

    Montreal, Canada

  • Mg0007 50069

    Toronto, Canada

  • Mg0007 50070

    Québec, Canada

  • Mg0007 50071

    Edmonton, Canada

  • Mg0007 50073

    Tampa, Florida, 33612, United States

  • Mg0007 50075

    Augusta, Georgia, 30912-0004, United States

  • Mg0007 50077

    New York, New York, 10021, United States

  • Mg0007 50090

    Winston-Salem, North Carolina, 27157, United States

  • Mg0007 50092

    Orange, California, 92868, United States

  • Mg0007 50096

    Philadelphia, Pennsylvania, 19104, United States

  • Mg0007 50099

    San Francisco, California, 94117, United States

  • Mg0007 50113

    Houston, Texas, 77030, United States

  • Mg0007 50114

    Indianapolis, Indiana, 46202, United States

  • Mg0007 50120

    Miami, Florida, 33144, United States

  • Mg0007 50121

    Lexington, Kentucky, 40536-0284, United States

  • Mg0007 50122

    Miami, Florida, 33136, United States

  • Mg0007 50124

    Montreal, Canada

  • Mg0007 50323

    Honolulu, Hawaii, 96817, United States

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