JPRN-jRCT2080225254CompletedPhase 3
A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
CB Japan Co., Ltd.0 sites18 target enrollmentStarted: July 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Participant must be >=18 years of age at the time of signing the informed consent
- •- Participant was eligible for MG0003 [NCT03971422] or MGC003 at the time of enrollment into either study and the participant either completed the Observation Period of MG0003 or MGC003 or required rescue therapy during the Observation Period of the lead-in studies
- •- Body weight >=35 kg at Visit 1
- •- Study participants may be male or female
- •- A male study participant must agree to use contraception
- •- Female study participants of childbearing potential must agree to use a highly effective method of birth control
- •- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •a) Not a woman of childbearing potential (WOCBP) OR
- •b) A WOCBP who agrees to follow the contraceptive guidance
Exclusion Criteria
- •- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, if applicable, chest X-rays (posterior anterior and lateral), and TB testing by a positive interferon-gamma release assay (IGRA)(not indeterminate)
- •- Participant 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 8 weeks following the final dose of study medication
- •- 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-activates of daily living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis
- •- Participant has absolute neutrophil count <1500 cells/mm^3
- •- Participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at randomization, and could jeopardize or compromise the study participant's ability to participate in this study
- •- Participant has 12-lead electrocardiogram (ECG) with findings considered to be clinically significant upon medical review. The clinical significance of the findings needs to be assessed by the Investigator to determine eligibility, and any queries regarding continuation of the study participant must be addressed with the Medical Monitor
- •- Study participant has renal impairment, defined as glomerular filtration rate (GFR) less than 60 ml/min/1.73 m^2
- •- Study participant has >3x upper limit of normal (ULN) of any of the following at Visit 1: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- •- Study participant has positive human immunodeficiency virus antibody test
- •- Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria MG0003 [NCT03971422] or MGC003, or discontinued study medication in either study, with the exception of discontinuation due to a need for rescue treatment
- •- Study participant is not considered capable of adhering to the protocol visit schedule, or medication intake according to the judgment of the Investigator
- •- Study participant has a lifetime history of suicide attempt (including an active attempt,
- •interrupted attempt, or aborted attempt), or had suicidal ideation since the last visit in MG0003 as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia- Suicide Severity Rating Scale (C-SSRS)
Investigators
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