Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- Registration Number
- NCT04225871
- Lead Sponsor
- UCB Biopharma SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Completion of a qualifying zilucoplan study
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 0.3 mg/kg zilucoplan (RA101495) zilucoplan (RA101495) -
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) From Baseline (Day 1) to Safety Follow-Up Visit (up to 36 months) 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score From Baseline (Day 1) to Week 12 The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 8 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe).
Change from Baseline to Week 12 in the the Quantitative Myasthenia Gravis (QMG) Score From Baseline (Day 1) to Week 12 The QMG test is a standardized quantitative strength scoring system and measures 13 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the QMG score. The QMG score can range from 0 (least severe) to 39 (most severe).
Change from Baseline to Week 12 in the Myasthenia Gravis Composite (MGC) Score From Baseline (Day 1) to Week 12 The MGC is a 10-item scale that has been used to measure the clinical status of patients with Myasthenia Gravis (MG) in order to evaluate treatment response. The MGC has 4-point Likerttype Scale response options ranging from 0 to 2, 3, 4, 5, 6 or 9 according to the item (weighted response options). The total score is the sum of all items (range 0-50) where higher scores indicate more severe impairment due to the disease.
Change from Baseline to Week 12 in the Myasthenia Gravis - Quality of Life revised (MG-QOL15r) Score From Baseline (Day 1) to Week 12 The MG-QOL15r is a 15-item survey that was designed to assess quality of life in patients with MG. The MG-QoL has 3-point Likert Scale response options ranging from 0 to 2. The MGQoL15r score can range from 0 to 30, where higher scores indicate more severe impact of the disease on aspects of the patient's life.
Related Research Topics
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Trial Locations
- Locations (70)
Mg0011 41
🇺🇸Mobile, Alabama, United States
Mg0011 116
🇺🇸Phoenix, Arizona, United States
Mg0011 31
🇺🇸Irvine, California, United States
MG0011 4
🇺🇸Los Angeles, California, United States
Mg0011 220
🇺🇸Pasadena, California, United States
Mg0011 160
🇺🇸San Francisco, California, United States
Mg0011 24
🇺🇸New Haven, Connecticut, United States
Mg0011 135
🇺🇸Augusta, Georgia, United States
Mg0011 188
🇺🇸Glenview, Illinois, United States
Mg0011 156
🇺🇸Indianapolis, Indiana, United States
Mg0011 32
🇺🇸Kansas City, Kansas, United States
Mg0011 33
🇺🇸Detroit, Michigan, United States
Mg0011 49
🇺🇸East Lansing, Michigan, United States
Mg0011 134
🇺🇸Columbia, Missouri, United States
Mg0011 117
🇺🇸Las Vegas, Nevada, United States
Mg0011 30
🇺🇸Buffalo, New York, United States
Mg0011 123
🇺🇸Great Neck, New York, United States
Mg0011 23
🇺🇸New York, New York, United States
Mg0011 47
🇺🇸New York, New York, United States
Mg0011 22
🇺🇸Chapel Hill, North Carolina, United States
Mg0011 122
🇺🇸Cleveland, Ohio, United States
Mg0011 38
🇺🇸Columbus, Ohio, United States
Mg0011 40
🇺🇸Pittsburgh, Pennsylvania, United States
Mg0011 128
🇺🇸Charleston, South Carolina, United States
Mg0011 28
🇺🇸Cordova, Tennessee, United States
Mg0011 131
🇺🇸Austin, Texas, United States
Mg0011 19
🇺🇸Dallas, Texas, United States
Mg0011 39
🇺🇸Salt Lake City, Utah, United States
Mg0011 164
🇺🇸Charlottesville, Virginia, United States
Mg0011 154
🇺🇸Seattle, Washington, United States
Mg0011 45
🇺🇸Milwaukee, Wisconsin, 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
🇮🇹Milano, 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-shi, 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
🇵🇱Kraków, Poland
Mg0011 205
🇵🇱Lublin, Poland
Mg0011 194
🇵🇱Nowa Sól, Poland
Mg0011 209
🇵🇱Poznań, Poland
Mg0011 201
🇵🇱Warszawa, Poland
Mg0011 210
🇵🇱Zabrze, Poland
Mg0011 214
🇵🇱Łódź, Poland
Mg0011 133
🇪🇸Barcelona, Spain
Mg0011 168
🇪🇸Barcelona, Spain
Mg0011 138
🇪🇸Bilbao, Spain
Mg0011 119
🇬🇧Oxford, United Kingdom
Mg0011 130
🇬🇧Sheffield, United Kingdom
Mg0011 27
🇺🇸Washington, District of Columbia, United States
Mg0011 25
🇺🇸Tampa, Florida, United States