Safety & Efffficacy of Genakumab in Patients With Frequent Flares

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 3

Conditions: Acute Gout Arthritis

Treatments: Drug: placebo for Diprospan; Drug: genakumab; Drug: placebo for genakumab; Drug: Diprospan

Study type: Interventional

Funder types: Industry

Identifiers

NCT05983445

GenSci048-301

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).

Full description

A multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of Genakumab versus compound betamethasone injection in adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.

Enrollment: 313 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years ≤ age ≤75 years
• BMI≤40kg/m2
• Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout.
• Start of acute gout flare within 4 days prior to enrolled
• History of ≥ 2 gout flares within the 12 months prior to study start
• Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines
• Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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313 participants in 2 patient groups

Genakumab

Experimental group

Description:

Genakumab 200mg s.c

Treatment:

Drug: genakumab

Drug: placebo for Diprospan

Diprospan

Active Comparator group

Description:

Diprospan 7mg im

Treatment:

Drug: Diprospan

Drug: placebo for genakumab