A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

Launched by SUNSHINE GUOJIAN PHARMACEUTICAL (SHANGHAI) CO., LTD. · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people with acute gout, which is a type of arthritis that causes sudden, severe pain and swelling in the joints. The study will test an injection of a special antibody designed to help reduce the pain and inflammation caused by gout. It aims to find out if this treatment is safe and effective for Chinese participants who have had frequent gout flare-ups.

To be eligible for the trial, participants need to be between 18 and 75 years old and have experienced at least three gout attacks in the past year. They should also currently be having a flare-up and have a certain level of pain. People with certain medical conditions, like severe kidney problems or recent infections, will not be able to participate. Those who join the study can expect to receive the treatment and will be monitored closely by medical staff to ensure their safety and to see how well the treatment works. The trial is not yet recruiting participants, but it aims to provide new options for managing gout in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Must be 18 Years to 75 Years, both male and female.
• • BMI ≤35 kg/m2.
• • Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
• • History of ≥ 3 gout flares within the 12 months prior to study randomization.
• • Onset of current acute gout flare within 4 days prior to study screening.
• • Screening pain intensity of the Target Joint ≥ 50 mm on the 0-100 mm VAS.
• • Contraindicated, intolerant or lack efficacy to NSAIDs and/or colchicine.
• • Accept uric acid lowering treatment according to the requirements of the protocol.
• Exclusion Criteria:
• • Gout caused by radiotherapy/chemotherapy, lead, organ transplantation, tumors, etc.
• • Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
• • Presence of severe renal function impairment.
• • Intolerance of subcutaneous and intramuscular injection.
• • Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment.
• • History of malignant tumor within 5 years before screening.
• • Live vaccinations within 8 weeks prior to the start of the study.
• • Use of forbidden therapy.