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

Gout Flare Clinical Trial

— Gensci 048-203  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936268
• Other study ID #: GenSci048-203
• Status: Recruiting
• Phase: Phase 2
• Start date: June 30, 2023
• Est. completion date: February 21, 2024

Study information

• Verified date: May 2023
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Ting Liu
• Phone: 13644409526
• Email: Liuting01[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: February 21, 2024
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

1. Male or female, 18 years = age = 75 years;

2. BMI = 40kg/m2

3. Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;

4. Start of acute gout flare within 3 days prior to enrolled;

5. History of =2 gout flare within 12 months prior to study start;

6. Baseline pain intensity = 50mm on the 0-100mm visual analog scale(VAS)

Related Conditions & MeSH terms

• Acute Gout
• Arthritis, Gouty
• Gout
• Gout Flare

Intervention

Drug:
• Genakumab for injection
150 mg/1ml/bottle
• Colchicine
0.5mg/table

Locations

Country	Name	City	State
China	Fudan University Affiliated Huashan Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	72hours target joint VAS change from baseline	72hours target joint VAS change from baseline	72h±2h
Secondary	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,
Secondary	Recurrence of flare	Proportion of patients who have at least 1 flare Time to first flare	12 weeks after the last dose
Secondary	Safety outcome	AE, laboratory examination, ECG, vital signs and physical examination	12weeks
Secondary	immunogenic outcome	The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody	12 weeks after the last dose