Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
RAISE-XT
A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis
3 other identifiers
interventional
200
10 countries
70
Brief Summary
The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.
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 Dec 2019
Longer than P75 for phase_3
70 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
October 2, 2019
CompletedStudy Start
First participant enrolled
December 23, 2019
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 2, 2026
April 24, 2026
April 1, 2026
6.4 years
October 2, 2019
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events (TEAEs)
A treatment-emergent adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
From Baseline (Day 1) to Safety Follow-Up Visit (up to 36 months)
Secondary Outcomes (4)
Change from Baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
From Baseline (Day 1) to Week 12
Change from Baseline to Week 12 in the the Quantitative Myasthenia Gravis (QMG) Score
From Baseline (Day 1) to Week 12
Change from Baseline to Week 12 in the Myasthenia Gravis Composite (MGC) Score
From Baseline (Day 1) to Week 12
Change from Baseline to Week 12 in the Myasthenia Gravis - Quality of Life revised (MG-QOL15r) Score
From Baseline (Day 1) to Week 12
Study Arms (1)
0.3 mg/kg zilucoplan (RA101495)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Completion of a qualifying zilucoplan study
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Mg0011 41
Mobile, Alabama, 36604, United States
Mg0011 116
Phoenix, Arizona, 85028, United States
Mg0011 31
Irvine, California, 92697, United States
MG0011 4
Los Angeles, California, 90033, United States
Mg0011 220
Pasadena, California, 91101, United States
Mg0011 160
San Francisco, California, 94115, United States
Mg0011 24
New Haven, Connecticut, 06511, United States
Mg0011 27
Washington D.C., District of Columbia, 20052, United States
Mg0011 25
Tampa, Florida, 33612, United States
Mg0011 135
Augusta, Georgia, 30912, United States
Mg0011 188
Glenview, Illinois, 60026-1339, United States
Mg0011 156
Indianapolis, Indiana, 46202, United States
Mg0011 32
Kansas City, Kansas, 66160, United States
Mg0011 33
Detroit, Michigan, 48201, United States
Mg0011 49
East Lansing, Michigan, 48824, United States
Mg0011 134
Columbia, Missouri, 65201, United States
Mg0011 117
Las Vegas, Nevada, 89145, United States
Mg0011 30
Buffalo, New York, 14202-1102, United States
Mg0011 123
Great Neck, New York, 11021, United States
Mg0011 23
New York, New York, 10021, United States
Mg0011 47
New York, New York, 10029, United States
Mg0011 22
Chapel Hill, North Carolina, 27599, United States
Mg0011 122
Cleveland, Ohio, 44195, United States
Mg0011 38
Columbus, Ohio, 43210, United States
Mg0011 40
Pittsburgh, Pennsylvania, 15212, United States
Mg0011 128
Charleston, South Carolina, 29425-8908, United States
Mg0011 28
Cordova, Tennessee, 38018, United States
Mg0011 131
Austin, Texas, 78759, United States
Mg0011 19
Dallas, Texas, 75390, United States
Mg0011 39
Salt Lake City, Utah, 84105, United States
Mg0011 164
Charlottesville, Virginia, 22903, United States
Mg0011 154
Seattle, Washington, 98195, United States
Mg0011 45
Milwaukee, Wisconsin, 53215, United States
Mg0011 11
Montreal, Canada
Mg0011 204
Lille, France
Mg0011 118
Nice, France
Mg0011 105
Paris, France
Mg0011 137
Strasbourg, France
Mg0011 150
Göttingen, Germany
Mg0011 129
Tübingen, Germany
Mg0011 132
Milan, Italy
Mg0011 126
Roma, Italy
Mg0011 151
Chiba, Japan
Mg0011 136
Hanamaki-shi, Japan
Mg0011 179
Kita-gun, Japan
Mg0011 153
Meguro-ku, Japan
Mg0011 146
Nagasaki, Japan
Mg0011 169
Narita, Japan
Mg0011 152
Sapporo, Japan
Mg0011 144
Sendai, Japan
Mg0011 163
Shinjuku-ku, Japan
Mg0011 141
Tokyo, Japan
Mg0011 140
Bergen, Norway
Mg0011 143
Oslo, Norway
Mg0011 195
Katowice, Poland
Mg0011 213
Katowice, Poland
Mg0011 192
Krakow, Poland
Mg0011 193
Krakow, Poland
Mg0011 211
Krakow, Poland
Mg0011 214
Lodz, Poland
Mg0011 205
Lublin, Poland
Mg0011 194
Nowa Sól, Poland
Mg0011 209
Poznan, Poland
Mg0011 201
Warsaw, Poland
Mg0011 210
Zabrze, Poland
Mg0011 133
Barcelona, Spain
Mg0011 168
Barcelona, Spain
Mg0011 138
Bilbao, Spain
Mg0011 119
Oxford, United Kingdom
Mg0011 130
Sheffield, United Kingdom
Related Publications (5)
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.
PMID: 38400914RESULTde 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.
PMID: 39314260RESULTHewamadduma 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.
PMID: 40504283RESULTHoward 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.
PMID: 38638673DERIVEDHoward 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.
PMID: 37059508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2019
First Posted
January 13, 2020
Study Start
December 23, 2019
Primary Completion (Estimated)
June 2, 2026
Study Completion (Estimated)
June 2, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- 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.