Clinical Trials List
2021-02-03 - 2024-01-25
Phase III
Not yet recruiting3
Recruiting1
Study ended1
ICD-10G70.00
Myasthenia gravis without (acute) exacerbation
ICD-10G70.01
Myasthenia gravis with (acute) exacerbation
ICD-9358.0
Myasthenia gravis
An open-label extension study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Hou-Chang Chiu Division of Neurology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 朱俊哲 Division of Neurology
- 張國軒 Division of Neurology
- Hong-Chou Kuo Division of Neurology
- 呂榮國 Division of Neurology
- Chin-Chang Huang Division of Neurology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Kon-Ping Lin Division of Neurology
- Yi-Chu Liao Division of Neurology
- 劉英杰 Division of Neurology
- 賴冠霖 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ching-Hua Lu Lu Division of Neurology
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- 許哲維 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1. Percentage of participants with treatment-emergent adverse events (TEAEs)
2. Percentage of participants with (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP)
Secondary end point(s) :
1. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MGADL) score within one treatment cycle
2. Change from Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) score within one treatment cycle
3. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) score within one treatment cycle
4. 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
5. Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO ‘Physical Fatigue’ score within one treatment cycle
6. Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO ‘Bulbar symptoms’ score within one treatment cycle
7. MG-ADL responder (2.0-point improvement from Baseline [Day 1] to end of Day 43) within one treatment cycle
8. Time to MG-ADL response (2.0-point improvement from Baseline [Day 1]) within one treatment cycle
9. Time between consecutive treatment cycles
Inclution Criteria
- Study participant must meet one of the following:
a) completed MG0003 [NCT03971422] or MGC003,
b) required rescue therapy during the Observation Period in MG0003
or
c) 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
- 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 (not indeterminate) QuantiFERON®-TB Gold Plus
- Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, MGC003, 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
The Estimated Number of Participants
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Taiwan
4 participants
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Global
167 participants
