Generalized myasthenia gravis MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Study participant must meet one of the following: a) completed MG0003 [NCT03971422] or MGC003, b) required rescue therapy during the Observation Period in MG0003 or c) completed at least 6 visits in MG0004 [NCT04124965] - Body weight =35 kg at Baseline (Day 1) - Study participants may be male or female 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 207 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: - Study participant has a known hypersensitivity to any components of the study medication - Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, if applicable, chest x-rays (posterior anterior and lateral), and TB testing by a positive (not indeterminate) QuantiFERON®-TB Gold Plus - Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, MGC003, or MG0004, or permanently discontinued study drug in either study - Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of rozanolixizumab - Study participant with severe (defined as Grade 3 on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG) ;Secondary Objective: Assess the efficacy of 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG) ;Primary end point(s): 1. Percentage of participants with treatment-emergent adverse events (TEAEs) 2. Percentage of participants with (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) ;Timepoint(s) of evaluation of this end point: 1.; 2. From Baseline (Day 1) to End of Study (average of 20 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score within one treatment cycle 2. Change from Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) score within one treatment cycle 3. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) score within one treatment cycle 4. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) ‘Muscle Weakness Fatigability’ score within one treatment cycle 5. Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO ‘Physical Fatigue’ score within one treatment cycle 6. Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO ‘Bulbar symptoms’ score within one treatment cycle 7. MG-ADL responder (=2.0-point improvement from Baseline [Day 1] to end of Day 43) within one treatment cycle 8. Time to MG-ADL response (=2.0-point improvement from Baseline [Day 1]) within one treatment cycle 9. Time between consecutive treatment cycles;Timepoint(s) of evaluation of this end point: 1. - 8. From Baseline (Day 1) to end of treatment cycle (up to 6 weeks) 9. From end of the previous treatment cycle (Day 43) to the next treatment cycle (Day 1) | — |
Countries
Belgium, Canada, China, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Italy, Japan, Poland, Russian Federation, Serbia, Spain, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed