Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare

A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05936268

Acronym

Gensci 048-203

Enrollment

106

Registered

2023-07-07

Start date

2023-07-21

Completion date

2024-02-28

Last updated

2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gout, Gout Flare

Keywords

Acute gout, Gout flare

Brief summary

To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy

Detailed description

Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) group.

Interventions

DRUGGenakumab for injection

150 mg/1ml/bottle

DRUGColchicine

0.5mg/table

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Acute gout patients with gout flare Group A: Genakumab 200mg single injection;Group B: Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Male or female, 18 years ≤ age ≤ 75 years; 2. BMI ≤ 40kg/m2 3. Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout; 4. Start of acute gout flare within 3 days prior to enrolled; 5. History of ≥2 gout flare within 12 months prior to study start; 6. Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)

Design outcomes

Primary

Measure	Time frame	Description
72hours target joint VAS change from baseline	72h±2h	72hours target joint VAS change from baseline

Secondary

Measure	Time frame	Description
Pain intensity	6hours, 24hours, 48hours, 72hours, Day 8,	target joint VAS Target joint VAS change from baseline Time to first VAS\<=50% baseline VAS Time to first VAS\<=30mm Time to first VAS\<=10mm
Recurrence of flare	12 weeks after the last dose	Proportion of patients who have at least 1 flare Time to first flare
Safety outcome	12weeks	AE, laboratory examination, ECG, vital signs and physical examination
immunogenic outcome	12 weeks after the last dose	The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026