Safety & Efffficacy of Genakumab in Patients With Frequent Flares

Safety & Efficacy of Genakumab in Patients With Frequent Flares

The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).

Study Overview

• Status: Completed
• Conditions: Acute Gout Arthritis
• Intervention / Treatment: Drug: genakumab; Drug: placebo for Diprospan; Drug: placebo for genakumab; Drug: Diprospan

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.

• Study Type: Interventional
• Enrollment (Actual): 313
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University Affiliated Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genakumab; Genakumab 200mg s.c	Drug: genakumab; 200mg s.c.; Other Names: • Gensci048; Drug: placebo for Diprospan; i.m.
Active Comparator: Diprospan; Diprospan 7mg im	Drug: placebo for genakumab; s.c.; Drug: Diprospan; 7mg i.m.

What is the study measuring?

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
The number of patients with at least 1 new gout flare		12 weeks, 24 weeks, 48 weeks
Time to first flare		24 weeks, 48 weeks
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
Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)		At 6, 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, 24, 48, and 72 hours and 7 days post-dose
Time to at Least a 50% Reduction in Baseline Pain Intensity		7 days
Percent Patients Who Took Rescue Medication		24 weeks,48 weeks
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)		24weeks, 48weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Sensitivity C-reactive Protein (hsCRP)		72 hours, 7 days and 4 weeks post-dose
SF-36	The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.	8 weeks, 24 weeks and 48 weeks

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): April 3, 2024
• Study Completion (Actual): April 3, 2024

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Acute Gout Arthritis
• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Gout; Arthritis; Arthritis, Gouty; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Respiratory System Agents; Anti-Asthmatic Agents; Betamethasone; Betamethasone dipropionate, betamethasone sodium phosphate drug combination
• Other Study ID Numbers: GenSci048-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No