A phase ?a, randomized, double-blind, placebo-parallel controlled, dose-exploration study of JMKX000189 in the treatment of moderate to severe active systemic lupus erythematosus

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: 2mg group:oral ;3mg group:oral ;0mg group:oral ; CONDITION: Moderate to severe active systemic lupus erythematosus PRIMARY OUTCOME: Peripheral blood lymphocyte count; SECONDARY OUTCOME: mSLEDAI‐2K scores;SLE SRI‐4;physician's global assessment PGA; INCLUSION CRITERIA: 1. Subjects must have been diagnosed with systemic lupus erythematosus at least 12 weeks prior to screening and must be assessed to meet 2019 EULAR/ACR SLE classification criteria during screening; 2. the subject must meet one of the following at screening: a. ANA titer =1:80;b. anti‐dsDNA antibody positive; c. Anti‐Smith antibody positive. 3. At least one of the following SLE background standard therapies (including no more than one immunosuppressant) was required for 12 weeks prior to randomization, and the dose must remain stable at least 30 days until randomization and throughout study participation.
Epistemonikos ID: c0b6fe34e1f8693fa8b0ea36a6b5ab11f5260d96
First added on: Feb 20, 2024