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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 February 2025 |
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Main ID: |
NCT04225871 |
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Date of registration:
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02/10/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
RAISE-XT |
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Scientific title:
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A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis |
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Date of first enrolment:
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December 23, 2019 |
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Target sample size:
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200 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04225871 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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France
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Germany
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Italy
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Japan
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Norway
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Poland
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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UCB Cares |
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Address:
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Telephone:
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Email:
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Affiliation:
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001 844 599 2273 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Completion of a qualifying zilucoplan study
Exclusion Criteria:
- With the exception of a prior zilucoplan trial, participation in another concurrent
clinical trial involving an experimental therapeutic intervention (participation in
observational studies and/or registry studies is permitted)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Generalized Myasthenia Gravis
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Intervention(s)
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Drug: zilucoplan (RA101495)
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Primary Outcome(s)
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Incidence of treatment-emergent adverse events (TEAEs)
[Time Frame: From Baseline (Day 1) to Safety Follow-Up Visit (up to 36 months)]
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Secondary Outcome(s)
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Change from Baseline to Week 12 in the Myasthenia Gravis - Quality of Life revised (MG-QOL15r) Score
[Time Frame: From Baseline (Day 1) to Week 12]
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Change from Baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
[Time Frame: From Baseline (Day 1) to Week 12]
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Change from Baseline to Week 12 in the Myasthenia Gravis Composite (MGC) Score
[Time Frame: From Baseline (Day 1) to Week 12]
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Change from Baseline to Week 12 in the the Quantitative Myasthenia Gravis (QMG) Score
[Time Frame: From Baseline (Day 1) to Week 12]
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Secondary ID(s)
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2024-512399-37
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U1111-1306-6625
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RA101495-02.302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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