Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE-XT)
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|ClinicalTrials.gov Identifier: NCT04225871|
Recruitment Status : Enrolling by invitation
First Posted : January 13, 2020
Last Update Posted : April 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Generalized Myasthenia Gravis||Drug: zilucoplan (RA101495)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis|
|Actual Study Start Date :||December 23, 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
|Experimental: 0.3 mg/kg zilucoplan (RA101495)||
Drug: zilucoplan (RA101495)
Daily subcutaneous (SC) injection
- Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 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.
- 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 ]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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225871
|Study Director:||UCB Cares||UCB Pharma|