Clinical Study of Genakumab for Injection in Patients With Acute Gout (NCT05328531) | Clinical Trial Compass
CompletedPhase 1/2
Clinical Study of Genakumab for Injection in Patients With Acute Gout
China121 participantsStarted 2021-05-22
Plain-language summary
To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Peak Plasma Concentration (Cmax)
Timeframe: baseline, 24hours, 48hours, 120hours, Day 7, Day 14, Day 21, Day 28, Day 56, Day 84, Day 112
2
pain intensity change from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS)