Safety & Efffficacy of Genakumab in Patients With Frequent Flares

Phase 3

Completed

• Conditions: Acute Gout Arthritis
• Interventions: Drug: genakumab; Drug: placebo for genakumab; Drug: placebo for Diprospan; Drug: Diprospan

• Registration Number: NCT05983445
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-12-20
• Study Start: 2023-01-11
• Study First Submitted QC: 2023-08-06
• Study First Posted: 2023-08-09
• Primary Completion: 2024-04-03
• Study Completion: 2024-04-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genakumab	genakumab	Genakumab 200mg s.c
Genakumab	placebo for Diprospan	Genakumab 200mg s.c
Diprospan	placebo for genakumab	Diprospan 7mg im
Diprospan	Diprospan	Diprospan 7mg im

Primary Outcome Measures

Name	Time	Method
The change in the gout pain intensity in the target joint measured by VAS	72 hours post-dose	The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
Time to first new flare	12 weeks

Secondary Outcome Measures

Name	Time	Method
Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)	At 6, 24, 48, and 72 hours and 7 days post-dose
The change in the gout pain intensity in the target joint measured by VAS.	At 6, 24, 48, and 72 hours and 7 days post-dose
The number of patients with at least 1 new gout flare	12 weeks, 24 weeks, 48 weeks
Time to at Least a 50% Reduction in Baseline Pain Intensity	7 days
Percent Patients Who Took Rescue Medication	24 weeks,48 weeks
Time to first flare	24 weeks, 48 weeks
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)	24weeks, 48weeks
Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody	24 weeks, 48 weeks
Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period	2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose	Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose.

Trial Locations

Locations (1)

Fudan University Affiliated Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China