Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
NCT ID: NCT04225871
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2019-12-23
2026-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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0.3 mg/kg zilucoplan (RA101495)
zilucoplan (RA101495)
Daily subcutaneous (SC) injection
Interventions
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zilucoplan (RA101495)
Daily subcutaneous (SC) injection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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 2273
Locations
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Pasadena, California, United States
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San Francisco, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Glenview, Illinois, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Detroit, Michigan, United States
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East Lansing, Michigan, United States
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Columbia, Missouri, United States
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Las Vegas, Nevada, United States
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Buffalo, New York, United States
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Great Neck, New York, United States
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New York, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Cordova, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Montreal, , Canada
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Lille, , France
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Nice, , France
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Paris, , France
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Strasbourg, , France
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Göttingen, , Germany
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Tübingen, , Germany
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Milan, , Italy
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Roma, , Italy
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Chiba, , Japan
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Hanamaki-shi, , Japan
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Kita-gun, , Japan
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Meguro-ku, , Japan
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Nagasaki, , Japan
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Narita, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Tokyo, , Japan
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Bergen, , Norway
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Oslo, , Norway
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Katowice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Nowa Sól, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Zabrze, , Poland
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Barcelona, , Spain
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Barcelona, , Spain
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Bilbao, , Spain
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Oxford, , United Kingdom
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Sheffield, , United Kingdom
Countries
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References
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Weiss MD, Freimer M, Leite MI, Maniaol A, Utsugisawa K, Bloemers J, Boroojerdi B, Howard E, Savic N, Howard JF Jr. Improvement of fatigue in generalised myasthenia gravis with zilucoplan. J Neurol. 2024 May;271(5):2758-2767. doi: 10.1007/s00415-024-12209-3. Epub 2024 Feb 24.
de la Borderie G, Chimits D, Boroojerdi B, Brock M, Duda PW, Grimson F, Mahoney P, Strimenopoulou F, Cutter G, Aban I, Brauner S, Petersson M, Howard JF Jr, Bennett N. Maintenance of zilucoplan efficacy in patients with generalised myasthenia gravis up to 24 weeks: a model-informed analysis. Ther Adv Neurol Disord. 2024 Sep 21;17:17562864241279125. doi: 10.1177/17562864241279125. eCollection 2024.
Hewamadduma C, Freimer M, Genge A, Leite MI, Utsugisawa K, Vu T, Boroojerdi B, Grimson F, Savic N, Vanderkelen M, Howard JF Jr; RAISE-XT study team. Changes in corticosteroid and non-steroidal immunosuppressive therapy with long-term zilucoplan treatment in generalized myasthenia gravis. J Neurol. 2025 Jun 12;272(7):457. doi: 10.1007/s00415-025-13113-0.
Howard JF Jr, Bresch S, Farmakidis C, Freimer M, Genge A, Hewamadduma C, Hinton J, Hussain Y, Juntas-Morales R, Kaminski HJ, Maniaol A, Mantegazza R, Masuda M, Nowak RJ, Sivakumar K, Smilowski M, Utsugisawa K, Vu T, Weiss MD, Zajda M, Bloemers J, Boroojerdi B, Brock M, de la Borderie G, Duda PW, Vanderkelen M, Leite MI; RAISE-XT Study Team*. Long-term safety and efficacy of zilucoplan in patients with generalized myasthenia gravis: interim analysis of the RAISE-XT open-label extension study. Ther Adv Neurol Disord. 2024 Apr 17;17:17562864241243186. doi: 10.1177/17562864241243186. eCollection 2024.
Howard JF Jr, Bresch S, Genge A, Hewamadduma C, Hinton J, Hussain Y, Juntas-Morales R, Kaminski HJ, Maniaol A, Mantegazza R, Masuda M, Sivakumar K, Smilowski M, Utsugisawa K, Vu T, Weiss MD, Zajda M, Boroojerdi B, Brock M, de la Borderie G, Duda PW, Lowcock R, Vanderkelen M, Leite MI; RAISE Study Team. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Neurol. 2023 May;22(5):395-406. doi: 10.1016/S1474-4422(23)00080-7.
Other Identifiers
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2024-512399-37
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1306-6625
Identifier Type: OTHER
Identifier Source: secondary_id
RA101495-02.302
Identifier Type: -
Identifier Source: org_study_id
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