Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma S.P.R.L.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject has a well-documented diagnosis of myasthenia gravis (MG) at Visit 1 (Screening), based on subject history and supported by previous evaluations
Subject would currently be considered for treatment with immunological therapy (immunoglobulin/plasma exchange (IVIG/PLEX)) by the investigator
Subject has a well-documented record of autoantibodies against anti-acetylcholine receptor (Anti-AChR) or anti-muscle specific kinase (Anti-MuSK) prior to Screening
Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential applicable will use a highly effective method of birth control
Male subjects must be willing to use a method of contraception
You may not be if
Subject has previously received treatment in this study or subject has previously been exposed to UCB7665
Subject has participated in another study of an investigational medicinal product (IMP; or a medical device) within the previous 30 days of Screening or is currently participating in another study of an investigational medicinal product (IMP; or a medical device)
Subject has a known hypersensitivity to any components of the IMP
Subject has a history of hyperprolinemia, since L-proline is a constituent of the UCB7665 IMP
Subjects with Myasthenia Gravis (MG) only affecting the ocular muscles
Subjects with severe weakness affecting oropharyngeal or respiratory muscles, or who have myasthenic crisis at Screening or impending crisis
Subject has quantitative myasthenia gravis (QMG) score of \<11 at Baseline
Subject has a serum total immunoglobulin G (IgG) level \<= 6g/L at Screening
Absolute neutrophil count \<1500 cells/mm\^3
Subject has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
Subject has any laboratory abnormality that, in the opinion of the investigator, is clinically significant, has not resolved at randomization, and could jeopardize or would compromise the subject's ability to participate in this study
Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
Subject has received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer)
Clareo Health | Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
