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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Gout, Gout Flare

Intervention / Treatment
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* Drug: Genakumab for injection
* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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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 3 days prior to enrolled; History of ≥2 gout flare within 12 months prior to study start; Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genacumab group<br>Genakumab 200mg single injection | Drug: Genakumab for injection<br>* 150 mg/1ml/bottle<br>|
| Active Comparator: cholchicine group<br>Colchicine 0.5mg qd po.for 12 weeks | Drug: Colchicine<br>* 0.5mg/table<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 72hours target joint VAS change from baseline | 72hours target joint VAS change from baseline | 72h±2h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | 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 | 6hours, 24hours, 48hours, 72hours, Day 8, | 
| Recurrence of flare | Proportion of patients who have at least 1 flare Time to first flare | 12 weeks after the last dose | 
| Safety outcome | AE, laboratory examination, ECG, vital signs and physical examination | 12weeks | 
| immunogenic outcome | The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody | 12 weeks after the last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute gout, Gout flare