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

NCT ID: NCT03971422

Last Updated: 2025-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2021-10-26

Brief Summary

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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).

Detailed Description

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Conditions

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Generalized Myasthenia Gravis

Keywords

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UCB7665 generalized myasthenia gravis rozanolixizumab gMG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dosage Regimen 1

Study participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.

Group Type EXPERIMENTAL

Rozanolixizumab

Intervention Type DRUG

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

Dosage Regimen 2

Study participants randomized to dosage regimen 2 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.

Group Type EXPERIMENTAL

Rozanolixizumab

Intervention Type DRUG

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

Placebo

Study participants randomized to this arm will receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subjects will receive placebo at pre-specified time points.

Interventions

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Rozanolixizumab

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

Intervention Type DRUG

Placebo

Subjects will receive placebo at pre-specified time points.

Intervention Type OTHER

Other Intervention Names

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UCB7665 PBO

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

+1 844 599 2273 (UCB)

Locations

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Mg0003 50081

Phoenix, Arizona, United States

Site Status

Mg0003 50082

Scottsdale, Arizona, United States

Site Status

Mg0003 50072

Los Angeles, California, United States

Site Status

Mg0003 50092

Orange, California, United States

Site Status

Mg0003 50097

San Francisco, California, United States

Site Status

Mg0003 50099

San Francisco, California, United States

Site Status

Mg0003 50101

Aurora, Colorado, United States

Site Status

Mg0003 50088

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

Site Status

Mg0003 50122

Miami, Florida, United States

Site Status

Mg0003 50120

Miami, Florida, United States

Site Status

Mg0003 50073

Tampa, Florida, United States

Site Status

Mg0003 50075

Augusta, Georgia, United States

Site Status

Mg0003 50323

Honolulu, Hawaii, United States

Site Status

Mg0003 50109

Chicago, Illinois, United States

Site Status

Mg0003 50114

Indianapolis, Indiana, United States

Site Status

Mg0003 50074

Fairway, Kansas, United States

Site Status

Mg0003 50121

Lexington, Kentucky, United States

Site Status

Mg0003 50110

Ann Arbor, Michigan, United States

Site Status

Mg0003 50102

Detroit, Michigan, United States

Site Status

Mg0003 50104

Rochester, Minnesota, United States

Site Status

Mg0003 50105

St Louis, Missouri, United States

Site Status

Mg0003 50077

New York, New York, United States

Site Status

Mg0003 50117

Charlotte, North Carolina, United States

Site Status

Mg0003 50086

Charlotte, North Carolina, United States

Site Status

Mg0003 50090

Winston-Salem, North Carolina, United States

Site Status

Mg0003 50076

Columbus, Ohio, United States

Site Status

Mg0003 50096

Philadelphia, Pennsylvania, United States

Site Status

Mg0003 50089

Philadelphia, Pennsylvania, United States

Site Status

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Charleston, South Carolina, United States

Site Status

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Houston, Texas, United States

Site Status

Mg0003 40121

Brussels, , Belgium

Site Status

Mg0003 50067

Calgary, , Canada

Site Status

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Montreal, , Canada

Site Status

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Québec, , Canada

Site Status

Mg0003 50069

Toronto, , Canada

Site Status

Mg0003 40125

Ostrava, , Czechia

Site Status

Mg0003 40124

Prague, , Czechia

Site Status

Mg0003 40128

Aalborg, , Denmark

Site Status

Mg0003 40127

Aarhus N, , Denmark

Site Status

Mg0003 40126

Copenhagen, , Denmark

Site Status

Mg0003 40489

Odense, , Denmark

Site Status

Mg0003 40129

Bordeaux, , France

Site Status

Mg0003 40070

Clermont-Ferrand, , France

Site Status

Mg0003 40512

Garches, , France

Site Status

Mg0003 40510

Le Kremlin-Bicêtre, , France

Site Status

Mg0003 40360

Limoges, , France

Site Status

Mg0003 40426

Lyon, , France

Site Status

Mg0003 40130

Marseille, , France

Site Status

Mg0003 40017

Nantes, , France

Site Status

Mg0003 40132

Nice, , France

Site Status

Mg0003 40133

Paris, , France

Site Status

Mg0003 40131

Strasbourg, , France

Site Status

Mg0003 20160

Tbilisi, , Georgia

Site Status

Mg0003 20161

Tbilisi, , Georgia

Site Status

Mg0003 20163

Tbilisi, , Georgia

Site Status

Mg0003 20165

Tbilisi, , Georgia

Site Status

Mg0003 40134

Essen, , Germany

Site Status

Mg0003 40140

Göttingen, , Germany

Site Status

Mg0003 40135

Gummersbach, , Germany

Site Status

Mg0003 40139

Jena, , Germany

Site Status

Mg0003 40078

Leipzig, , Germany

Site Status

Mg0003 40177

Münster, , Germany

Site Status

Mg0003 40082

Kistarcsa, , Hungary

Site Status

Mg0003 40178

Nyíregyháza, , Hungary

Site Status

Mg0003 40283

Bologna, , Italy

Site Status

Mg0003 40149

Lazio, , Italy

Site Status

Mg0003 40144

Milan, , Italy

Site Status

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Napoli, , Italy

Site Status

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Pavia, , Italy

Site Status

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Roma, , Italy

Site Status

Mg0003 40150

Roma, , Italy

Site Status

Mg0003 20035

Bunkyō City, , Japan

Site Status

Mg0003 20068

Chiba, , Japan

Site Status

Mg0003 20078

Hanamaki-Shi, , Japan

Site Status

Mg0003 20079

Hiroshima, , Japan

Site Status

Mg0003 20075

Kobe, , Japan

Site Status

Mg0003 20071

Nagasaki, , Japan

Site Status

Mg0003 20074

Ōsaka-sayama, , Japan

Site Status

Mg0003 20067

Sapporo, , Japan

Site Status

Mg0003 20077

Sendai, , Japan

Site Status

Mg0003 20070

Shinjuku-Ku, , Japan

Site Status

Mg0003 20076

Shinjuku-Ku, , Japan

Site Status

Mg0003 20032

Suita, , Japan

Site Status

Mg0003 40155

Gdansk, , Poland

Site Status

Mg0003 40154

Lodz, , Poland

Site Status

Mg0003 40151

Lublin, , Poland

Site Status

Mg0003 40153

Poznan, , Poland

Site Status

Mg0003 20168

Krasnoyarsk, , Russia

Site Status

Mg0003 20027

Moscow, , Russia

Site Status

Mg0003 20169

Novosibirsk, , Russia

Site Status

Mg0003 20001

Saint Petersburg, , Russia

Site Status

Mg0003 20028

Saint Petersburg, , Russia

Site Status

Mg0003 20029

Saint Petersburg, , Russia

Site Status

Mg0003 20055

Saint Petersburg, , Russia

Site Status

Mg0003 20197

Samara, , Russia

Site Status

Mg0003 40468

Belgrade, , Serbia

Site Status

Mg0003 40467

Niš, , Serbia

Site Status

Mg0003 40159

Barcelona, , Spain

Site Status

Mg0003 40160

Barcelona, , Spain

Site Status

Mg0003 40267

Barcelona, , Spain

Site Status

Mg0003 40157

L'Hospitalet de Llobregat, , Spain

Site Status

Mg0003 40161

Madrid, , Spain

Site Status

Mg0003 40162

Madrid, , Spain

Site Status

Mg0003 40341

Málaga, , Spain

Site Status

Mg0003 40350

Murcia, , Spain

Site Status

Mg0003 40308

San Sebastián de los Reyes, , Spain

Site Status

Mg0003 20080

Taichung, , Taiwan

Site Status

Mg0003 20081

Taipei, , Taiwan

Site Status

Mg0003 20086

Taipei, , Taiwan

Site Status

Mg0003 20082

Taoyuan District, , Taiwan

Site Status

Mg0003 40175

London, , United Kingdom

Site Status

Mg0003 40168

Nottingham, , United Kingdom

Site Status

Countries

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United States Belgium Canada Czechia Denmark France Georgia Germany Hungary Italy Japan Poland Russia Serbia Spain Taiwan United Kingdom

References

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Bril V, Druzdz A, Grosskreutz J, Habib AA, Mantegazza R, Sacconi S, Utsugisawa K, Vissing J, Vu T, Boehnlein M, Bozorg A, Gayfieva M, Greve B, Woltering F, Kaminski HJ; MG0003 study team. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023 May;22(5):383-394. doi: 10.1016/S1474-4422(23)00077-7.

Reference Type RESULT
PMID: 37059507 (View on PubMed)

Habib AA, Sacconi S, Antonini G, Cortes-Vicente E, Grosskreutz J, Mahuwala ZK, Mantegazza R, Pascuzzi RM, Utsugisawa K, Vissing J, Vu T, Wiendl H, Boehnlein M, Greve B, Woltering F, Bril V. Efficacy and safety of rozanolixizumab in patients with muscle-specific tyrosine kinase autoantibody-positive generalised myasthenia gravis: a subgroup analysis of the randomised, double-blind, placebo-controlled, adaptive phase III MycarinG study. Ther Adv Neurol Disord. 2024 Sep 12;17:17562864241273036. doi: 10.1177/17562864241273036. eCollection 2024.

Reference Type RESULT
PMID: 39297052 (View on PubMed)

Kaminski HJ, Antozzi C, Habib AA, Pascuzzi RM, Sacconi S, Utsugisawa K, Vissing J, Regnault A, Hareendran A, Grimson F, Tarancon T, Bril V; MycarinG study investigators. Improvement in Patient-Reported Symptoms of Generalised Myasthenia Gravis With Rozanolixizumab in the Randomised Phase 3 MycarinG Study Using the MG Symptoms PRO. Eur J Neurol. 2025 Aug;32(8):e70231. doi: 10.1111/ene.70231.

Reference Type RESULT
PMID: 40755069 (View on PubMed)

Barnett-Tapia C, Cortes Vicente E, Pascuzzi RM, Utsugisawa K, Bloemers J, Grimson F, Tarancon T, Bril V; MycarinG study investigators. Measuring the effect of rozanolixizumab using the Myasthenia Gravis Impairment Index: analyses from the randomized phase 3 MycarinG study. J Neurol. 2025 Nov 8;272(12):752. doi: 10.1007/s00415-025-13480-8.

Reference Type RESULT
PMID: 41205003 (View on PubMed)

Regnault A, Habib AA, Creel K, Kaminski HJ, Morel T. Clinical meaningfulness and psychometric robustness of the MG Symptoms PRO scales in clinical trials in adults with myasthenia gravis. Front Neurol. 2024 Jun 24;15:1368525. doi: 10.3389/fneur.2024.1368525. eCollection 2024.

Reference Type DERIVED
PMID: 38978809 (View on PubMed)

Matic A, Alfaidi N, Bril V. An evaluation of rozanolixizumab-noli for the treatment of anti-AChR and anti-MuSK antibody-positive generalized myasthenia gravis. Expert Opin Biol Ther. 2023 Jul-Dec;23(12):1163-1171. doi: 10.1080/14712598.2023.2296126. Epub 2023 Dec 28.

Reference Type DERIVED
PMID: 38099334 (View on PubMed)

Bril V, Benatar M, Andersen H, Vissing J, Brock M, Greve B, Kiessling P, Woltering F, Griffin L, Van den Bergh P; MG0002 Investigators. Efficacy and Safety of Rozanolixizumab in Moderate to Severe Generalized Myasthenia Gravis: A Phase 2 Randomized Control Trial. Neurology. 2021 Feb 9;96(6):e853-e865. doi: 10.1212/WNL.0000000000011108. Epub 2020 Nov 20.

Reference Type DERIVED
PMID: 33219142 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-000968-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MG0003

Identifier Type: -

Identifier Source: org_study_id