A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
2 other identifiers
interventional
165
14 countries
69
Brief Summary
The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).
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 Feb 2021
Typical duration for phase_3
69 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
November 5, 2020
CompletedFirst Posted
Study publicly available on registry
December 3, 2020
CompletedStudy Start
First participant enrolled
February 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2024
CompletedResults Posted
Study results publicly available
April 18, 2025
CompletedApril 18, 2025
April 1, 2025
3 years
November 5, 2020
January 22, 2025
April 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE was defined as any event that was not present prior to first dose of investigational medicinal product (IMP), or any unresolved event already present that worsened in intensity following treatment, up to 8 weeks after end of Treatment Period or after last dose of IMP in participants who discontinued study or IMP.
From Baseline (Day 1) to End of Study (up to 34 months)
Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (IMP)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to permanent withdrawal of study medication.
From Baseline (Day 1) to End of Study (up to 34 months)
Secondary Outcomes (9)
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score Within One Treatment Cycle (Cycle 1, 2, and 3)
From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3)
From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3)
From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score Within One Treatment Cycle (Cycle 1, 2, and 3)
From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3)
From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
- +4 more secondary outcomes
Study Arms (2)
Rozanolixizumab dosage regimen 1
EXPERIMENTALStudy participants randomized/assigned to dosage regimen 1 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.
Rozanolixizumab dosage regimen 2
EXPERIMENTALStudy participants randomized/assigned to dosage regimen 2 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.
Interventions
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Eligibility Criteria
You may qualify if:
- Study participant must meet one of the following:
- completed MG0003 \[NCT03971422\]
- required rescue therapy during the Observation Period in MG0003 or
- completed at least 6 visits in MG0004 \[NCT04124965\]
- Body weight ≥35 kg at Baseline (Day 1)
- Study participants may be male or female
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Mg0007 50092
Orange, California, 92868, United States
Mg0007 50099
San Francisco, California, 94117, United States
Mg0007 50122
Miami, Florida, 33136, United States
Mg0007 50120
Miami, Florida, 33144, United States
Mg0007 50073
Tampa, Florida, 33612, United States
Mg0007 50075
Augusta, Georgia, 30912-0004, United States
Mg0007 50323
Honolulu, Hawaii, 96817, United States
Mg0007 50114
Indianapolis, Indiana, 46202, United States
Mg0007 50121
Lexington, Kentucky, 40536-0284, United States
Mg0007 50077
New York, New York, 10021, United States
Mg0007 50090
Winston-Salem, North Carolina, 27157, United States
Mg0007 50096
Philadelphia, Pennsylvania, 19104, United States
Mg0007 50113
Houston, Texas, 77030, United States
Mg0007 50071
Edmonton, Canada
Mg0007 50066
Montreal, Canada
Mg0007 50124
Montreal, Canada
Mg0007 50070
Québec, Canada
Mg0007 50069
Toronto, Canada
Mg0007 40125
Ostrava - Poruba, Czechia
Mg0007 40124
Prague, Czechia
Mg0007 40128
Aalborg, Denmark
Mg0007 40127
Aarhus, Denmark
Mg0007 40126
Copenhagen, Denmark
Mg0007 40129
Bordeaux, France
Mg0007 40360
Limoges, France
Mg0007 40132
Nice, France
Mg0007 40133
Paris, France
Mg0007 40131
Strasbourg, France
Mg0007 20160
Tbilisi, Georgia
Mg0007 20161
Tbilisi, Georgia
Mg0007 20163
Tbilisi, Georgia
Mg0007 20164
Tbilisi, Georgia
Mg0007 20165
Tbilisi, Georgia
Mg0007 40134
Essen, Germany
Mg0007 40140
Göttingen, Germany
Mg0007 40139
Jena, Germany
Mg0007 40078
Leipzig, Germany
Mg0007 40177
Münster, Germany
Mg0007 40283
Bologna, Italy
Mg0007 40144
Milan, Italy
Mg0007 40307
Napoli, Italy
Mg0007 40146
Pavia, Italy
Mg0007 40148
Roma, Italy
Mg0007 40150
Roma, Italy
Mg0007 20035
Bunkyō City, Japan
Mg0007 20068
Chiba, Japan
Mg0007 20078
Hanamaki-shi, Japan
Mg0007 20079
Hiroshima, Japan
Mg0007 20075
Kobe, Japan
Mg0007 20071
Nagasaki, Japan
Mg0007 20077
Sendai, Japan
Mg0007 20070
Shinjuku-ku, Japan
Mg0007 20076
Shinjuku-ku, Japan
Mg0007 20032
Suita, Japan
Mg0007 40155
Gdansk, Poland
Mg0007 40154
Lodz, Poland
Mg0007 40151
Lublin, Poland
Mg0007 40153
Poznan, Poland
Mg0007 20169
Novosibirsk, Russia
Mg0007 20001
Saint Petersburg, Russia
Mg0007 20028
Saint Petersburg, Russia
Mg0007 20055
Saint Petersburg, Russia
Mg0007 40467
Niš, Serbia
Mg0007 40160
Barcelona, Spain
Mg0007 40157
L'Hospitalet de Llobregat, Spain
Mg0007 40350
Murcia, Spain
Mg0007 40308
San Sebastián de los Reyes, Spain
Mg0007 20081
Taipei, Taiwan
Mg0007 20086
Taipei, Taiwan
Related Publications (2)
Bril V, Druzdz A, Grosskreutz J, Habib AA, Kaminski HJ, Mantegazza R, Sacconi S, Utsugisawa K, Vu T, Boehnlein M, Gayfieva M, Greve B, Woltering F, Vissing J; MG0004 study investigators. Safety and efficacy of chronic weekly rozanolixizumab in generalized myasthenia gravis: the randomized open-label extension MG0004 study. J Neurol. 2025 Mar 19;272(4):275. doi: 10.1007/s00415-025-12958-9.
PMID: 40105996DERIVEDBril 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: 37059507DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 22733 (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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2020
First Posted
December 3, 2020
Study Start
February 3, 2021
Primary Completion
January 25, 2024
Study Completion
January 25, 2024
Last Updated
April 18, 2025
Results First Posted
April 18, 2025
Record last verified: 2025-04
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.