Phase 3
Completed N=200
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Source: ClinicalTrials.gov NCT03971422 ↗Enrolled (actual)
200
Serious AEs
9.0%
Results posted
Aug 2023
Primary outcomePrimary: Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score — -0.784; -3.370; -3.403 units on a scale — p=<0.001
◆ Published Evidence
Highly cited
266citations · ~89 / 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 the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).
Linked Publications (5)
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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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Efficacy and safety of rozanolixizumab in patients with muscle-specific tyrosine kinase autoantibody-positive generalised myasthenia gravis: a subgroup analysis of the randomised, double-blind, placebo-controlled, adaptive phase III MycarinG study.
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Improvement in Patient-Reported Symptoms of Generalised Myasthenia Gravis With Rozanolixizumab in the Randomised Phase 3 MycarinG Study Using the MG Symptoms PRO.
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Measuring the effect of rozanolixizumab using the Myasthenia Gravis Impairment Index: analyses from the randomized phase 3 MycarinG study.
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Clinical meaningfulness and psychometric robustness of the MG Symptoms PRO scales in clinical trials in adults with myasthenia gravis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score |
-0.784; -3.370; -3.403 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43 |
28.4; 68.2; 61.2 | <0.001 sig |
| SECONDARY Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score |
-2.029; -5.930; -7.554 | <0.001 sig |
| SECONDARY Change From Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) Total Score |
-1.915; -5.398; -6.672 | <0.001 sig |
| SECONDARY Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score |
-10.588; -23.029; -25.751 | <0.001 sig |
| SECONDARY Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Physical Fatigue' Score |
-10.637; -19.287; -25.459 | 0.012 sig |
| SECONDARY Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Bulbar Symptoms' Score |
-3.519; -14.839; -14.224 | <0.001 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
45; 52; 57 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Investigational Medicinal Product (IMP) |
2; 2; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Study participant must be ≥18 years of age, at the time of signing the informed consent
- Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations
- Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at Screening (Visit 1).The presence of autoantibodies may be confirmed with repeat testing at Visit 1
- Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1
- Study participant with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 3 (with ≥3 points from non-ocular symptom) AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline (Visit 2)
- Study participant is considered for additional treatment such as intravenous immunoglobulin g (IVIg) or plasma exchange (PEX) by the Investigator
Exclusion Criteria
- Study participant has a known history of hyperprolinemia
- Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
- 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) will be excluded
- Study participant has experienced hypersensitivity reaction after exposure to other anti-neonatal Fc receptor (FcRn) drugs
- 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 at Visit 1 or Visit 2
- Study participant has a history of a solid organ transplant or hematopoietic stem cell/marrow transplant
Data sourced from ClinicalTrials.gov (NCT03971422) 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.