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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04225871
Other study ID # RA101495-02.302
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 23, 2019
Est. completion date June 2, 2026

Study information

Verified date May 2024
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date June 2, 2026
Est. primary completion date June 2, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Drug:
zilucoplan (RA101495)
Daily subcutaneous (SC) injection

Locations

Country Name City State
Canada Mg0011 11 Montreal
France Mg0011 204 Lille
France Mg0011 118 Nice
France Mg0011 105 Paris
France Mg0011 137 Strasbourg
Germany Mg0011 150 Göttingen
Germany Mg0011 129 Tübingen
Italy Mg0011 132 Milano
Italy Mg0011 126 Roma
Japan 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
Norway Mg0011 140 Bergen
Norway Mg0011 143 Oslo
Poland Mg0011 195 Katowice
Poland Mg0011 213 Katowice
Poland Mg0011 192 Krakow
Poland Mg0011 193 Krakow
Poland Mg0011 211 Kraków
Poland Mg0011 214 Lódz
Poland Mg0011 205 Lublin
Poland Mg0011 194 Nowa Sol
Poland Mg0011 209 Poznan
Poland Mg0011 201 Warszawa
Poland Mg0011 210 Zabrze
Spain Mg0011 133 Barcelona
Spain Mg0011 168 Barcelona
Spain Mg0011 138 Bilbao
United Kingdom Mg0011 119 Oxford
United Kingdom Mg0011 130 Sheffield
United States Mg0011 135 Augusta Georgia
United States Mg0011 131 Austin Texas
United States Mg0011 30 Buffalo New York
United States Mg0011 22 Chapel Hill North Carolina
United States Mg0011 128 Charleston South Carolina
United States Mg0011 164 Charlottesville Virginia
United States Mg0011 122 Cleveland Ohio
United States Mg0011 134 Columbia Missouri
United States Mg0011 38 Columbus Ohio
United States Mg0011 28 Cordova Tennessee
United States Mg0011 19 Dallas Texas
United States Mg0011 33 Detroit Michigan
United States Mg0011 49 East Lansing Michigan
United States Mg0011 188 Glenview Illinois
United States Mg0011 123 Great Neck New York
United States Mg0011 156 Indianapolis Indiana
United States Mg0011 31 Irvine California
United States Mg0011 32 Kansas City Kansas
United States Mg0011 117 Las Vegas Nevada
United States MG0011 4 Los Angeles California
United States Mg0011 45 Milwaukee Wisconsin
United States Mg0011 41 Mobile Alabama
United States Mg0011 24 New Haven Connecticut
United States Mg0011 23 New York New York
United States Mg0011 47 New York New York
United States Mg0011 220 Pasadena California
United States Mg0011 116 Phoenix Arizona
United States Mg0011 40 Pittsburgh Pennsylvania
United States Mg0011 39 Salt Lake City Utah
United States Mg0011 160 San Francisco California
United States Mg0011 154 Seattle Washington
United States Mg0011 25 Tampa Florida
United States Mg0011 27 Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Ra Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Japan,  Norway,  Poland,  Spain,  United Kingdom, 

References & Publications (1)

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- — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from Baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score 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). From Baseline (Day 1) to Week 12
Secondary Change from Baseline to Week 12 in the the Quantitative Myasthenia Gravis (QMG) Score 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). From Baseline (Day 1) to Week 12
Secondary Change from Baseline to Week 12 in the Myasthenia Gravis Composite (MGC) Score 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. From Baseline (Day 1) to Week 12
Secondary Change from Baseline to Week 12 in the Myasthenia Gravis - Quality of Life revised (MG-QOL15r) Score 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. From Baseline (Day 1) to Week 12
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