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New drug shows promise for rare Muscle-Weakening disease

NCT ID NCT03971422

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tested a drug called rozanolixizumab in 200 adults with generalized myasthenia gravis, a condition that causes muscle weakness. The goal was to see if the drug improves daily activities and is safe compared to a placebo. Participants received either the drug or a dummy treatment, and researchers measured changes in symptoms over 43 days.

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

200 people

The number who actually took part.

Started

Jun 2019

Finished

Oct 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: * Study participant must be ≥18 years of age, at the time of signing the informed consent * Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations * Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at Screening (Visit 1).The presence of autoantibodies may be confirmed with repeat testing at Visit 1 * Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1 * Study participant with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 3 (with ≥3 points from non-ocular symptom) AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline (Visit 2) * Study participant is considered for additional treatment such as intravenous immunoglobulin g (IVIg) or plasma exchange (PEX) by the Investigator Exclusion Criteria: * Study participant has a known history of hyperprolinemia * Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP) * 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) will be excluded * 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-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis at Visit 1 or Visit 2 * Study participant has a history of a solid organ transplant or hematopoietic stem cell/marrow transplant

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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

  • Mg0003 20001

    Saint Petersburg, Russia

  • Mg0003 20027

    Moscow, Russia

  • Mg0003 20028

    Saint Petersburg, Russia

  • Mg0003 20029

    Saint Petersburg, Russia

  • Mg0003 20032

    Suita, Japan

  • Mg0003 20035

    Bunkyō City, Japan

  • Mg0003 20055

    Saint Petersburg, Russia

  • Mg0003 20067

    Sapporo, Japan

  • Mg0003 20068

    Chiba, Japan

  • Mg0003 20070

    Shinjuku-Ku, Japan

  • Mg0003 20071

    Nagasaki, Japan

  • Mg0003 20074

    Ōsaka-sayama, Japan

  • Mg0003 20075

    Kobe, Japan

  • Mg0003 20076

    Shinjuku-Ku, Japan

  • Mg0003 20077

    Sendai, Japan

  • Mg0003 20078

    Hanamaki-Shi, Japan

  • Mg0003 20079

    Hiroshima, Japan

  • Mg0003 20080

    Taichung, Taiwan

  • Mg0003 20081

    Taipei, Taiwan

  • Mg0003 20082

    Taoyuan, Taiwan

  • Mg0003 20086

    Taipei, Taiwan

  • Mg0003 20160

    Tbilisi, Georgia

  • Mg0003 20161

    Tbilisi, Georgia

  • Mg0003 20163

    Tbilisi, Georgia

  • Mg0003 20165

    Tbilisi, Georgia

  • Mg0003 20168

    Krasnoyarsk, Russia

  • Mg0003 20169

    Novosibirsk, Russia

  • Mg0003 20197

    Samara, Russia

  • Mg0003 40017

    Nantes, France

  • Mg0003 40070

    Clermont-Ferrand, France

  • Mg0003 40078

    Leipzig, Germany

  • Mg0003 40082

    Kistarcsa, Hungary

  • Mg0003 40121

    Brussels, Belgium

  • Mg0003 40124

    Prague, Czechia

  • Mg0003 40125

    Ostrava, Czechia

  • Mg0003 40126

    Copenhagen, Denmark

  • Mg0003 40127

    Aarhus N, Denmark

  • Mg0003 40128

    Aalborg, Denmark

  • Mg0003 40129

    Bordeaux, France

  • Mg0003 40130

    Marseille, France

  • Mg0003 40131

    Strasbourg, France

  • Mg0003 40132

    Nice, France

  • Mg0003 40133

    Paris, France

  • Mg0003 40134

    Essen, Germany

  • Mg0003 40135

    Gummersbach, Germany

  • Mg0003 40139

    Jena, Germany

  • Mg0003 40140

    Göttingen, Germany

  • Mg0003 40144

    Milan, Italy

  • Mg0003 40146

    Pavia, Italy

  • Mg0003 40148

    Roma, Italy

  • Mg0003 40149

    Lazio, Italy

  • Mg0003 40150

    Roma, Italy

  • Mg0003 40151

    Lublin, Poland

  • Mg0003 40153

    Poznan, Poland

  • Mg0003 40154

    Lodz, Poland

  • Mg0003 40155

    Gdansk, Poland

  • Mg0003 40157

    L'Hospitalet de Llobregat, Spain

  • Mg0003 40159

    Barcelona, Spain

  • Mg0003 40160

    Barcelona, Spain

  • Mg0003 40161

    Madrid, Spain

  • Mg0003 40162

    Madrid, Spain

  • Mg0003 40168

    Nottingham, United Kingdom

  • Mg0003 40175

    London, United Kingdom

  • Mg0003 40177

    Münster, Germany

  • Mg0003 40178

    Nyíregyháza, Hungary

  • Mg0003 40267

    Barcelona, Spain

  • Mg0003 40283

    Bologna, Italy

  • Mg0003 40307

    Naples, Italy

  • Mg0003 40308

    San Sebastián de los Reyes, Spain

  • Mg0003 40341

    Málaga, Spain

  • Mg0003 40350

    Murcia, Spain

  • Mg0003 40360

    Limoges, France

  • Mg0003 40426

    Lyon, France

  • Mg0003 40467

    Niš, Serbia

  • Mg0003 40468

    Belgrade, Serbia

  • Mg0003 40489

    Odense, Denmark

  • Mg0003 40510

    Le Kremlin-Bicêtre, France

  • Mg0003 40512

    Garches, France

  • Mg0003 50066

    Montreal, Canada

  • Mg0003 50067

    Calgary, Canada

  • Mg0003 50069

    Toronto, Canada

  • Mg0003 50070

    Québec, Canada

  • Mg0003 50072

    Los Angeles, California, 90033, United States

  • Mg0003 50073

    Tampa, Florida, 33612, United States

  • Mg0003 50074

    Fairway, Kansas, 66205, United States

  • Mg0003 50075

    Augusta, Georgia, 30912, United States

  • Mg0003 50076

    Columbus, Ohio, 43210, United States

  • Mg0003 50077

    New York, New York, 10021, United States

  • Mg0003 50081

    Phoenix, Arizona, 85013, United States

  • Mg0003 50082

    Scottsdale, Arizona, 85251, United States

  • Mg0003 50084

    Charleston, South Carolina, 29425, United States

  • Mg0003 50086

    Charlotte, North Carolina, 28207, United States

  • Mg0003 50088

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

  • Mg0003 50089

    Philadelphia, Pennsylvania, 19140, United States

  • Mg0003 50090

    Winston-Salem, North Carolina, 27157, United States

  • Mg0003 50092

    Orange, California, 92868, United States

  • Mg0003 50096

    Philadelphia, Pennsylvania, 19104, United States

  • Mg0003 50097

    San Francisco, California, 94109, United States

  • Mg0003 50099

    San Francisco, California, 94117, United States

  • Mg0003 50101

    Aurora, Colorado, 80045, United States

  • Mg0003 50102

    Detroit, Michigan, 48202, United States

  • Mg0003 50104

    Rochester, Minnesota, 55905, United States

  • Mg0003 50105

    St Louis, Missouri, 63110, United States

  • Mg0003 50109

    Chicago, Illinois, 60637, United States

  • Mg0003 50110

    Ann Arbor, Michigan, 48109, United States

  • Mg0003 50113

    Houston, Texas, 77030, United States

  • Mg0003 50114

    Indianapolis, Indiana, 46202, United States

  • Mg0003 50117

    Charlotte, North Carolina, 28204, United States

  • Mg0003 50120

    Miami, Florida, 33144, United States

  • Mg0003 50121

    Lexington, Kentucky, 40536, United States

  • Mg0003 50122

    Miami, Florida, 33136, United States

  • Mg0003 50323

    Honolulu, Hawaii, 96817, United States

More trials for these conditions

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