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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the target dose of phase II and to evaluate the safety, tolerability, pharmacokinetics and efficacy of recombinant anti-IL-1β humanized monoclonal antibody injection at different doses in Chinese participants with acute gout.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Betamethasone; Immunoglobulins

Criteria

Inclusion Criteria:

• Must be 18 Years to 65 Years, both male and female

• Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.

• Presence of acute gout flare for no longer than 7 days

• Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS

• Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both

Exclusion Criteria:

• Secondary gout (such as gout caused by chemotherapy, transplant gout, 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 3 months prior to the start of the study

• Use of forbidden therapy