Status:
COMPLETED
Clinical Study of Genakumab for Injection in Patients With Acute Gout
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Huashan Hospital
Hainan General Hospital
Conditions:
Acute Gout
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout
Detailed Description
Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose groups with 10 participant s in each group. Phase II: randomized, double-blind, active control design.There are...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2022
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT05328531
Start Date
May 22 2021
End Date
June 9 2022
Last Update
February 27 2025
Active Locations (1)
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1
Shanghai Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 310000