CompletedPhase 2

A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)

China165 participantsStarted 2023-07-20

Plain-language summary

To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

1. Signed written informed consent before any study procedure is performed. 2. Male or female, 18 years ≤ age ≤ 75 years. 3. BMI ≤ 40kg/m2. 4. Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of arthritis of primary gout. 5. History of ≥2 gout flare within 12 months prior to screening. 6. Willingness to initiate urate-lowering therapy or having initiated urate-lowering therapy within 1 week prior to screening

What they're measuring

Mean Number of Gout Flares Per Participant

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT05936281

SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-19

View on ClinicalTrials.gov More Gout trials