A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS
- Conditions
- Myasthenia Gravis
- Registration Number
- JPRN-jRCT2021210024
- Lead Sponsor
- Ivana Vodopivec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
1. Signed Informed Consent Form
2. Age >= 12 years at time of signing Informed Consent Form
3. Confirmed diagnosis of gMG
- Documented history of myasthenic weakness
- MG severity of MGFA Class II, III, or IV at screening
- The confirmation of the diagnosis has to be supported by positive serologic test for one of the three antibody types: anti-AChR, anti-MuSK or anti-LRP4 at screening
4. A total MG ADL score of >= 5 points at screening with more than 50% of this score attributed to non-ocular items
5. Ongoing gMG standard treatment at a stable dose
6. No contraindication to at least one of the rescue treatments: IVIg, PE, or high dose corticosteroids
1. History of thymic cysts, thymoma, thymic carcinoma or other neoplasm of the thymus as defined by the 2015 WHO classification of tumors of the thymus (Marx et al. 2015) unless deemed cured by adequate treatment with no evidence of recurrence for >= 5 years before screening.
2. History of thymectomy within 12 months prior to screening
3. Ocular MG (MGFA Class I)
4. Myasthenic crisis within the last 3 months prior to screening (MGFA Class V)
5. Known disease other than gMG that would interfere with the course and conduct of the study (such as severe RA or symptomatic [overt] hyperthyroidism or hypothyroidism)
6. Patients receiving with prohibited therapy or prohibited medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method