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

Acute Gout Clinical Trial

— Gensci 048-202  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05936281
• Other study ID #: GenSci 048-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2023
• Est. completion date: February 21, 2024

Study information

• Verified date: March 2023
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Jing Si Li
• Phone: 18301941524
• Email: lijingsi[@]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 initiating urico-lowering therapy

Description:

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.

Recruitment information / eligibility

• Status: Not yet 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. History of =2 gout flare within 12 months prior to study start;

5. Initiate uric-lowering therapy or initiated uric-lowering therapy within 1 week prior to screening

Related Conditions & MeSH terms

• Acute Gout
• Gout

Intervention

Drug:
• Genakumab for injection
150 mg/1ml/bottle
• Etoricorxib
60mg/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	The number of acute episodes of gout in 12 weeks		12 weeks
Secondary	Proportion of subjects with at least one acute episode within 12 weeks		12 weeks
Secondary	Random to the time of the first acute onset		12 weeks
Secondary	Duration of acute gout attacks over a 12-week period		12 weeks
Secondary	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
Secondary	immunogenic outcome	The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody	12 weeks