A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
2 other identifiers
interventional
200
17 countries
112
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2019
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedResults Posted
Study results publicly available
August 21, 2023
CompletedDecember 24, 2025
December 1, 2025
2.2 years
May 29, 2019
July 27, 2023
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (PRO) instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement.
Baseline and Day 43
Secondary Outcomes (8)
Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43
Day 43
Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score
Baseline and Day 43
Change From Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) Total Score
Baseline and Day 43
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score
Baseline and Day 43
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Physical Fatigue' Score
Baseline and Day 43
- +3 more secondary outcomes
Study Arms (3)
Dosage Regimen 1
EXPERIMENTALStudy participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.
Dosage Regimen 2
EXPERIMENTALStudy participants randomized to dosage regimen 2 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.
Placebo
PLACEBO COMPARATORStudy participants randomized to this arm will receive placebo.
Interventions
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (112)
Mg0003 50081
Phoenix, Arizona, 85013, United States
Mg0003 50082
Scottsdale, Arizona, 85251, United States
Mg0003 50072
Los Angeles, California, 90033, United States
Mg0003 50092
Orange, California, 92868, 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 50088
Washington D.C., District of Columbia, 20037, United States
Mg0003 50122
Miami, Florida, 33136, United States
Mg0003 50120
Miami, Florida, 33144, United States
Mg0003 50073
Tampa, Florida, 33612, United States
Mg0003 50075
Augusta, Georgia, 30912, United States
Mg0003 50323
Honolulu, Hawaii, 96817, United States
Mg0003 50109
Chicago, Illinois, 60637, United States
Mg0003 50114
Indianapolis, Indiana, 46202, United States
Mg0003 50074
Fairway, Kansas, 66205, United States
Mg0003 50121
Lexington, Kentucky, 40536, United States
Mg0003 50110
Ann Arbor, Michigan, 48109, 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 50077
New York, New York, 10021, United States
Mg0003 50117
Charlotte, North Carolina, 28204, United States
Mg0003 50086
Charlotte, North Carolina, 28207, United States
Mg0003 50090
Winston-Salem, North Carolina, 27157, United States
Mg0003 50076
Columbus, Ohio, 43210, United States
Mg0003 50096
Philadelphia, Pennsylvania, 19104, United States
Mg0003 50089
Philadelphia, Pennsylvania, 19140, United States
Mg0003 50084
Charleston, South Carolina, 29425, United States
Mg0003 50113
Houston, Texas, 77030, 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 District, Taiwan
Mg0003 40175
London, United Kingdom
Mg0003 40168
Nottingham, United Kingdom
Related Publications (7)
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.
PMID: 37059507RESULTHabib 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.
PMID: 39297052RESULTKaminski 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.
PMID: 40755069RESULTBarnett-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.
PMID: 41205003RESULTRegnault 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.
PMID: 38978809DERIVEDMatic 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.
PMID: 38099334DERIVEDBril 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.
PMID: 33219142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2019
First Posted
June 3, 2019
Study Start
June 3, 2019
Primary Completion
August 31, 2021
Study Completion
October 26, 2021
Last Updated
December 24, 2025
Results First Posted
August 21, 2023
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.