A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients With Generalized Myasthenia Gravis

RC18G006

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

2024-06-01

2026-04-01

2027-07-01

Not yet recruiting

Early phase I

180

Key Inclusion Criteria: 1. Male or female patient aged ≥18 years at screening. 2. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV. 3. Patients have positive antibodies against AChR or MuSK at screening. 4. MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score. 5. QMG score ≥11 points at screening and baseline. Key Exclusion Criteria: 1. Patients have been diagnosed with any other autoimmune disease. 2. Patients having acute or chronic infection. 3. Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening. 4. Patients having current or history of primary immunodeficiency. 5. Patients having history of malignancy within the last 5 years. 6. Patient having prior or continuing diagnosis of serious cardiovascular disease.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}

2024-06-13