Generalized Myasthenia Gravis MedDRA version: 20.0 Level: LLT Classification code 10028415 Term: Myasthenia System Organ Class: 100000004859
Conditions
Sponsors
Ra Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this study, subjects must meet ALL the following inclusion criteria: 1.Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IV] at Screening 2.Positive serology for acetylcholine receptor (AChR) binding autoantibodies 3.MG-ADL Score of =6 at Screening and Baseline 4.QMG Score of =12 at Screening and Baseline (off acetylcholinesterase inhibitor therapy for at least 10 hours) 5.No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated to occur during the 12-week treatment period 6.No change in immunosuppressive therapy, including dose, for at least 30 days prior to Baseline or anticipated to occur during the 12-week treatment period Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Subjects who meet ANY of the following exclusion criteria must be excluded from the study: 1.Thymectomy within 12 months prior to baseline or scheduled to occur during the 12-week study 2.History of meningococcal disease 3.Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To confirm the efficacy of zilucoplan in subjects with gMG •To confirm the safety and tolerability of zilucoplan in subjects with gMG;Secondary Objective: Not Applicable;Primary end point(s): •Change from Baseline (CFB) to Week 12 in the MG-ADL Score;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •CFB to Week 12 in the QMG Score •CFB to Week 12 in the MG Composite (MGC) •CFB to Week 12 in the MG-QOL15r Survey;Timepoint(s) of evaluation of this end point: week 12 | — |
Countries
Canada, France, Germany, Italy, Japan, Norway, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Ra Pharmaceuticals, Inc.
Outcome results
None listed