Safety & Efficacy of Genakumab in Patients With Frequent Flares

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout

Detailed Description
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Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose groups with 10 participant s in each group. Phase II: randomized, double-blind, active control design.There are 2 dose groups of Genakumab for Injection with 30 participant s in each group and 1 group of Compound Betamethasone Injection with 30 praticipants.

Official Title
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Safety & Efficacy of Genakumab in Patients With Frequent Flares

Conditions
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Acute Gout

Intervention / Treatment
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* Drug: genakumab
* Drug: placebo for Diprospan
* Drug: placebo for genakumab
* Drug: Diprospan


Participation Criteria
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Eligibility Criteria
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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: -

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genakumab<br>Genakumab 200mg s.c | Drug: genakumab<br>* 200mg s.c.<br>* Other names: • Gensci048;Drug: placebo for Diprospan<br>* i.m.<br>|
| Active Comparator: Diprospan<br>Diprospan 7mg im | Drug: placebo for genakumab<br>* s.c.<br>Drug: Diprospan<br>* 7mg i.m.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the gout pain intensity in the target joint measured by VAS | 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. | 72 hours post-dose | 
| Time to first new flare |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm) |  | At 6, 12, 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, 12, 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 |  | 12 weeks | 
| Percent Patients Who Took Rescue Medication |  | 12 weeks | 
| Time to first flare |  | 24 weeks, 48 weeks | 
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) |  | 12 weeks, 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 | Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose. | 2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute gout