NCT07377773

QLS12010 in Participants With Moderate-to-severe Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Rheumatoid Arthritis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	QLS12010	QLS12010 oral capsule
DRUG	placebo	Matching placebo oral capsule

Timeline

• Start date: 2026-03-05
• Primary completion: 2028-03-05
• Completion: 2028-06-05
• First posted: 2026-01-30
• Last updated: 2026-02-02