An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Overview
- Phase
- Phase 3
- Intervention
- Rozanolixizumab
- Conditions
- Generalized Myasthenia Gravis
- Sponsor
- UCB Biopharma SRL
- Enrollment
- 165
- Locations
- 69
- Primary Endpoint
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Study participant must meet one of the following:
- •completed MG0003 \[NCT03971422\]
- •required rescue therapy during the Observation Period in MG0003 or
- •completed at least 6 visits in MG0004 \[NCT04124965\]
- •Body weight ≥35 kg at Baseline (Day 1)
- •Study participants may be male or female
Exclusion Criteria
- •Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications
- •Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
- •Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, 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
Arms & Interventions
Rozanolixizumab dosage regimen 1
Study participants randomized/assigned to dosage regimen 1 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.
Intervention: Rozanolixizumab
Rozanolixizumab dosage regimen 2
Study participants randomized/assigned to dosage regimen 2 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.
Intervention: Rozanolixizumab
Outcomes
Primary Outcomes
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From Baseline (Day 1) to End of Study (up to 34 months)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE was defined as any event that was not present prior to first dose of investigational medicinal product (IMP), or any unresolved event already present that worsened in intensity following treatment, up to 8 weeks after end of Treatment Period or after last dose of IMP in participants who discontinued study or IMP.
Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (IMP)
Time Frame: From Baseline (Day 1) to End of Study (up to 34 months)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to permanent withdrawal of study medication.
Secondary Outcomes
- Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score Within One Treatment Cycle (Cycle 1, 2, and 3)(From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3))
- Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3)(From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3))
- Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3)(From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3))
- 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 (Cycle 1, 2, and 3)(From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3))
- Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3)(From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3))
- Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar Muscle Weakness' Score Within One Treatment Cycle (Cycle 1, 2, and 3)(From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3))
- MG-ADL Responder Rate (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3 [Day 43])(Day 43 of Cycle 1, 2, and 3)
- Time to MG-ADL Response (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3)(From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3))
- Time Between Consecutive Treatment Cycles(From end of the 6-week treatment cycle (Day 43) to the next 6-week treatment cycle (Day 1), assessed up to 2.5 years)