Clinical trial NCT05983445: Safety & Efffficacy of Genakumab in Patients With Frequent Flares
Official title: Safety & Efficacy of Genakumab in Patients With Frequent Flares
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gout Arthritis
Keywords: Acute Gout Arthritis
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-09
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: The change in the gout pain intensity in the target joint measured by VAS
timeFrame: 72 hours post-dose
measure: Time to first new flare
timeFrame: 12 weeks
Secondary outcomes:
measure: Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)
timeFrame: At 6, 24, 48, and 72 hours and 7 days post-dose
measure: The change in the gout pain intensity in the target joint measured by VAS.
timeFrame: At 6, 24, 48, and 72 hours and 7 days post-dose
measure: The number of patients with at least 1 new gout flare
timeFrame: 12 weeks, 24 weeks, 48 weeks
measure: Time to at Least a 50% Reduction in Baseline Pain Intensity
timeFrame: 7 days
measure: Percent Patients Who Took Rescue Medication
timeFrame: 24 weeks,48 weeks
measure: Time to first flare
timeFrame: 24 weeks, 48 weeks
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 24weeks, 48weeks
measure: Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
timeFrame: 24 weeks, 48 weeks
measure: Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period
timeFrame: 2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose
Other outcomes:
measure: High Sensitivity C-reactive Protein (hsCRP)
timeFrame: 72 hours, 7 days and 4 weeks post-dose
measure: SF-36
timeFrame: 8 weeks, 24 weeks and 48 weeks
Locations:
city: Shanghai
country: China
facility: Fudan University Affiliated Huashan Hospital
state: Shanghai
Study officials:
References: