RecruitingPhase 2NCT07233655

A Phase II Trial of SHR-3045 Injection in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of SHR-3045 Injection in Patients With Moderate to Severe Active Rheumatoid Arthritis


Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

30 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is ongoing to explore the efficacy and safety of different strengths of SHR-3045 injection in moderate to severe active rheumatoid arthritis.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new injectable drug called SHR-3045 for people with moderate-to-severe active rheumatoid arthritis (RA) — a chronic autoimmune disease that causes painful, swollen joints. Researchers want to see how well and how safely it works in people who haven't responded to other RA treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with moderate-to-severe active rheumatoid arthritis - At least one prior RA treatment (conventional or biologic) has not worked well enough or caused intolerable side effects - Your weight and BMI are within study requirements **You may NOT be eligible if...** - You are under 18 or over 75 years old - Your RA is mild or currently well controlled - You have active serious infections (e.g., tuberculosis, hepatitis) - You have had recent major surgery, a heart event, or cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-3045 Injection

SHR-3045 injection.

DRUGSHR-3045 Injection Placebo

SHR-3045 injection placebo.


Locations(1)

Peking University People 's Hospital

Beijing, Beijing Municipality, China

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NCT07233655