Phase 3
Completed N=165
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Source: ClinicalTrials.gov NCT04650854 ↗Enrolled (actual)
165
Serious AEs
23.6%
Results posted
Apr 2025
Primary outcomePrimary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) — 78.4; 94.1 percentage of participants
◆ Published Evidence
Highly cited
262citations · ~87 / year
Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study.
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).
Linked Publications (2)
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Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study.
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Safety and efficacy of chronic weekly rozanolixizumab in generalized myasthenia gravis: the randomized open-label extension MG0004 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
78.4; 94.1 | — |
| PRIMARY Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (IMP) |
9.8; 16.7 | — |
| SECONDARY 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) |
-3.7; -3.1; -2.9; -3.8; -3.3; -3.2 | — |
| SECONDARY Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3) |
-4.5; -4.1; -3.9; -4.9; -5.1; -4.2 | — |
| SECONDARY Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3) |
-7.6; -4.7; -5.7; -7.5; -6.8; -6.1 | — |
| SECONDARY 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) |
-17.6; -14.6; -13.2; -19.2; -12.8; -15.4 | — |
| SECONDARY Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3) |
-16.5; -14.8; -13.6; -16.0; -15.3; -15.0 | — |
| SECONDARY 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) |
-13.4; -11.6; -10.4; -15.5; -14.0; -13.0 | — |
| SECONDARY MG-ADL Responder Rate (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3 [Day 43]) |
74.3; 63.6; 62.5; 67.7; 73.2; 67.2 | — |
| SECONDARY Time to MG-ADL Response (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3) |
9.00; 22.00; 15.00; 15.00; 15.00; 15.00 | — |
| SECONDARY Time Between Consecutive Treatment Cycles |
64.0; 51.0; 58.0; 50.0; 42.5; 43.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT04650854) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.