The objective of this randomized, double-blind, placebo-controlled phase II clinical trial is to investigate the safety and efficacy of QLS12010 in subjects with moderate-to-severe rheumatoid arthritis.The main questions it aims to answer are: • Efficacy and safety of QLS12010 in participants with rheumatoid arthritis. Participants will be randomly allocated to four treatment groups at a 1:1:1:1 ratio to compare the efficacy and safety of different dosages of QLS12010 Capsules against the placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Change in Disease Activity Score-C-Reactive Protein (DAS28-CRP) from Baseline at Week 12.
The DAS28-CRP score measures how active rheumatoid arthritis is. A score of 2.6 or lower indicates disease remission, while a greater score indicates more severe disease.
Time frame: 12 weeks
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