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NCT03971422

PHASE3

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Sponsor: UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2019-06-03

Completion Date

2021-10-26

Last Updated

2026-08-20

Healthy Volunteers

Conditions

Generalized Myasthenia Gravis

Interventions

DRUG

Rozanolixizumab

Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.

OTHER

Placebo

Subjects will receive placebo at pre-specified time points.

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

Locations (112)

Mg0003 50081

Phoenix, Arizona, United States

Mg0003 50082

Scottsdale, Arizona, United States

Mg0003 50072

Los Angeles, California, United States

Mg0003 50092

Orange, California, United States

Mg0003 50097

San Francisco, California, United States

Mg0003 50099

San Francisco, California, United States

Mg0003 50101

Aurora, Colorado, United States

Mg0003 50088

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

Mg0003 50122

Miami, Florida, United States

Mg0003 50120

Miami, Florida, United States

Mg0003 50073

Tampa, Florida, United States

Mg0003 50075

Augusta, Georgia, United States

Mg0003 50323

Honolulu, Hawaii, United States

Mg0003 50109

Chicago, Illinois, United States

Mg0003 50114

Indianapolis, Indiana, United States

Mg0003 50074

Fairway, Kansas, United States

Mg0003 50121

Lexington, Kentucky, United States

Mg0003 50110

Ann Arbor, Michigan, United States

Mg0003 50102

Detroit, Michigan, United States

Mg0003 50104

Rochester, Minnesota, United States

Mg0003 50105

St Louis, Missouri, United States

Mg0003 50077

New York, New York, United States

Mg0003 50117

Charlotte, North Carolina, United States

Mg0003 50086

Charlotte, North Carolina, United States

Mg0003 50090

Winston-Salem, North Carolina, United States

Mg0003 50076

Columbus, Ohio, United States

Mg0003 50096

Philadelphia, Pennsylvania, United States

Mg0003 50089

Philadelphia, Pennsylvania, United States

Mg0003 50084

Charleston, South Carolina, United States

Mg0003 50113

Houston, Texas, United States

Mg0003 40121

Brussels, Belgium

Mg0003 50067

Calgary, Canada

Mg0003 50066

Montreal, Canada

Mg0003 50070

Québec, Canada

Mg0003 50069

Toronto, Canada

Mg0003 40125

Ostrava, Czechia

Mg0003 40124

Prague, Czechia

Mg0003 40128

Aalborg, Denmark

Mg0003 40127

Aarhus N, Denmark

Mg0003 40126

Copenhagen, Denmark

Mg0003 40489

Odense, Denmark

Mg0003 40129

Bordeaux, France

Mg0003 40070

Clermont-Ferrand, France

Mg0003 40512

Garches, France

Mg0003 40510

Le Kremlin-Bicêtre, France

Mg0003 40360

Limoges, France

Mg0003 40426

Lyon, France

Mg0003 40130

Marseille, France

Mg0003 40017

Nantes, France

Mg0003 40132

Nice, France

Mg0003 40133

Paris, France

Mg0003 40131

Strasbourg, France

Mg0003 20160

Tbilisi, Georgia

Mg0003 20161

Tbilisi, Georgia

Mg0003 20163

Tbilisi, Georgia

Mg0003 20165

Tbilisi, Georgia

Mg0003 40134

Essen, Germany

Mg0003 40140

Göttingen, Germany

Mg0003 40135

Gummersbach, Germany

Mg0003 40139

Jena, Germany

Mg0003 40078

Leipzig, Germany

Mg0003 40177

Münster, Germany

Mg0003 40082

Kistarcsa, Hungary

Mg0003 40178

Nyíregyháza, Hungary

Mg0003 40283

Bologna, Italy

Mg0003 40149

Lazio, Italy

Mg0003 40144

Milan, Italy

Mg0003 40307

Naples, Italy

Mg0003 40146

Pavia, Italy

Mg0003 40148

Roma, Italy

Mg0003 40150

Roma, Italy

Mg0003 20035

Bunkyō City, Japan

Mg0003 20068

Chiba, Japan

Mg0003 20078

Hanamaki-Shi, Japan

Mg0003 20079

Hiroshima, Japan

Mg0003 20075

Kobe, Japan

Mg0003 20071

Nagasaki, Japan

Mg0003 20074

Ōsaka-sayama, Japan

Mg0003 20067

Sapporo, Japan

Mg0003 20077

Sendai, Japan

Mg0003 20070

Shinjuku-Ku, Japan

Mg0003 20076

Shinjuku-Ku, Japan

Mg0003 20032

Suita, Japan

Mg0003 40155

Gdansk, Poland

Mg0003 40154

Lodz, Poland

Mg0003 40151

Lublin, Poland

Mg0003 40153

Poznan, Poland

Mg0003 20168

Krasnoyarsk, Russia

Mg0003 20027

Moscow, Russia

Mg0003 20169

Novosibirsk, Russia

Mg0003 20001

Saint Petersburg, Russia

Mg0003 20028

Saint Petersburg, Russia

Mg0003 20029

Saint Petersburg, Russia

Mg0003 20055

Saint Petersburg, Russia

Mg0003 20197

Samara, Russia

Mg0003 40468

Belgrade, Serbia

Mg0003 40467

Niš, Serbia

Mg0003 40159

Barcelona, Spain

Mg0003 40160

Barcelona, Spain

Mg0003 40267

Barcelona, Spain

Mg0003 40157

L'Hospitalet de Llobregat, Spain

Mg0003 40161

Madrid, Spain

Mg0003 40162

Madrid, Spain

Mg0003 40341

Málaga, Spain

Mg0003 40350

Murcia, Spain

Mg0003 40308

San Sebastián de los Reyes, Spain

Mg0003 20080

Taichung, Taiwan

Mg0003 20081

Taipei, Taiwan

Mg0003 20086

Taipei, Taiwan

Mg0003 20082

Taoyuan, Taiwan

Mg0003 40175

London, United Kingdom

Mg0003 40168

Nottingham, United Kingdom

Clinical Research Directory

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)