Safety and Efficacy of Genakumab for Injection in Patients With Gout Initiating Urico-lowering Therapy

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 initiating urico-lowering therapy

Detailed Description
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Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 100mg single injection group、 Genakumab 200mg single injection group or colchicine 0.5mg qd po.for 12 weeks 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 in Preventing Acute Attacks of Gouty Arthritis in Patients With Gout Initiating Urico-lowering Therapy

Conditions
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Acute Gout, Gout Initiating Urico-lowering Therapy

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


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; History of ≥2 gout flare within 12 months prior to study start; Initiate uric-lowering therapy or initiated uric-lowering therapy within 1 week prior to screening

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 initiating urico-lowering therapy Group A: Genakumab 100mg single injection; Group B: Genakumab 200mg single injection;Group C: Colchicine 0.5mg qd po.for 12 weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genakumab group<br>Genakumab 100mg single injection,Genakumab 200mg single injection | Drug: Genakumab for injection<br>* 150 mg/1ml/bottle<br>|
| Active Comparator: Colchicine group<br>Colchicine 0.5mg qd po.for 12 weeks | Drug: Etoricorxib<br>* 60mg/table<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of acute episodes of gout in 12 weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with at least one acute episode within 12 weeks |  | 12 weeks | 
| Random to the time of the first acute onset |  | 12 weeks | 
| Duration of acute gout attacks over a 12-week period |  | 12 weeks | 
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards | 12 weeks | 
| immunogenic outcome | The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute gout, urico-lowering therapy