Clinical Study of Genakumab for Injection in Patients With Acute Gout

• Status: Active, not recruiting
• Trial end date: 2022-05-28
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout

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

Details

• Lead Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Affiliated Hospital of Nantong University; Changhai Hospital; Hainan General Hospital; Huashan Hospital; Linyi People's Hospital; Shengjing Hospital; The First Affiliated Hospital with Nanjing Medical University; The Second Affiliated Hospital of Chongqing Medical University

Criteria

Inclusion Criteria:

• Male or female, 18 years ≤ age ≤65 years

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

• Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine

• Body mass index of less than or equal to 45 kg/m2

• Onset of current acute gout flare within 5 days prior to study entry

• Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)

• History of gout flare prior to study entry

Exclusion criteria:

• evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

• Presence of severe renal function impairment

• Use of specified pain relief medications or biologics ( corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor) within specified periods prior to study entry

• Live vaccinations within 3 months prior to randomization

• Requirement for administration of antibiotics against latent tuberculosis (TB)

• Any active or recurrent bacterial, fungal, or viral infection

• QTc>450ms for male, QTc>470ms for female