A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Completed · Phase 3 · Has a placebo group
Conditions studied: Generalized Myasthenia Gravis
In brief
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).
Key facts
- Study ID
- NCT03971422
- Run by
- UCB Biopharma SRL
- People needed
- 200
- Starts
- 2019-06-03
- Expected to finish
- 2021-10-26
- Last updated by the study team
- 2025-12-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mg0003 50082 — Scottsdale, Arizona, United States
- Mg0003 50072 — Los Angeles, California, United States
- Mg0003 50092 — Orange, California, United States
- Mg0003 50097 — San Francisco, California, United States
- Mg0003 50099 — San Francisco, California, United States
- Mg0003 50101 — Aurora, Colorado, United States
- Mg0003 50088 — Washington D.C., District of Columbia, United States
- Mg0003 50122 — Miami, Florida, United States
- Mg0003 50120 — Miami, Florida, United States
- Mg0003 50073 — Tampa, Florida, United States
- Mg0003 50075 — Augusta, Georgia, United States
- Mg0003 50323 — Honolulu, Hawaii, United States
- Mg0003 50109 — Chicago, Illinois, United States
- Mg0003 50114 — Indianapolis, Indiana, United States
- Mg0003 50074 — Fairway, Kansas, United States
- Mg0003 50121 — Lexington, Kentucky, United States
- Mg0003 50110 — Ann Arbor, Michigan, United States
- Mg0003 50102 — Detroit, Michigan, United States
- Mg0003 50104 — Rochester, Minnesota, United States
- Mg0003 50105 — St Louis, Missouri, United States
- Mg0003 50077 — New York, New York, United States
- Mg0003 50117 — Charlotte, North Carolina, United States
- Mg0003 50086 — Charlotte, North Carolina, United States
- Mg0003 50090 — Winston-Salem, North Carolina, United States
- Mg0003 50081 — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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