A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
NCT ID: NCT04650854
Last Updated: 2025-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2021-02-03
2024-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rozanolixizumab dosage regimen 1
Study 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
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Rozanolixizumab dosage regimen 2
Study 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.
Rozanolixizumab
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Interventions
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Rozanolixizumab
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. completed MG0003 \[NCT03971422\]
2. required rescue therapy during the Observation Period in MG0003 or
3. completed at least 6 visits in MG0004 \[NCT04124965\]
* Body weight ≥35 kg at Baseline (Day 1)
* Study participants may be male or female
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 22733 (UCB)
Locations
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Mg0007 50092
Orange, California, United States
Mg0007 50099
San Francisco, California, United States
Mg0007 50122
Miami, Florida, United States
Mg0007 50120
Miami, Florida, United States
Mg0007 50073
Tampa, Florida, United States
Mg0007 50075
Augusta, Georgia, United States
Mg0007 50323
Honolulu, Hawaii, United States
Mg0007 50114
Indianapolis, Indiana, United States
Mg0007 50121
Lexington, Kentucky, United States
Mg0007 50077
New York, New York, United States
Mg0007 50090
Winston-Salem, North Carolina, United States
Mg0007 50096
Philadelphia, Pennsylvania, United States
Mg0007 50113
Houston, Texas, 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
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-003230-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MG0007
Identifier Type: -
Identifier Source: org_study_id
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