Back to resultsSafety and Efficacy of Genakumab for Injection in Patients With Gout Flare (Gensci 048-203)
Primary Purpose
Acute Gout, Gout Flare
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Genakumab for injection
Colchicine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gout focused on measuring Acute gout, Gout flare
Eligibility 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 3 days prior to enrolled; History of ≥2 gout flare within 12 months prior to study start; Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)
Sites / Locations
- Fudan University Affiliated Huashan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Genacumab group
cholchicine group
Arm Description
Genakumab 200mg single injection
Colchicine 0.5mg qd po.for 12 weeks
Outcomes
Primary Outcome Measures
72hours target joint VAS change from baseline
72hours target joint VAS change from baseline
Secondary Outcome Measures
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
Recurrence of flare
Proportion of patients who have at least 1 flare Time to first flare
Safety outcome
AE, laboratory examination, ECG, vital signs and physical examination
immunogenic outcome
The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
Full Information
NCT ID
NCT05936268
First Posted
June 30, 2023
Last Updated
July 10, 2023
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Huashan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05936268
Brief Title
Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
February 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gout, Gout Flare
Keywords
Acute gout, Gout flare
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Acute gout patients with gout flare Group A: Genakumab 200mg single injection;Group B: Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Genacumab group
Arm Type
Experimental
Arm Description
Genakumab 200mg single injection
Arm Title
cholchicine group
Arm Type
Active Comparator
Arm Description
Colchicine 0.5mg qd po.for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Genakumab for injection
Intervention Description
150 mg/1ml/bottle
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
0.5mg/table
Primary Outcome Measure Information:
Title
72hours target joint VAS change from baseline
Description
72hours target joint VAS change from baseline
Time Frame
72h±2h
Secondary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
6hours, 24hours, 48hours, 72hours, Day 8,
Title
Recurrence of flare
Description
Proportion of patients who have at least 1 flare Time to first flare
Time Frame
12 weeks after the last dose
Title
Safety outcome
Description
AE, laboratory examination, ECG, vital signs and physical examination
Time Frame
12weeks
Title
immunogenic outcome
Description
The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
Time Frame
12 weeks after the last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 3 days prior to enrolled;
History of ≥2 gout flare within 12 months prior to study start;
Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Liu
Phone
13644409526
Email
Liuting01@gensci-china.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hejian Zou
Organizational Affiliation
Fudan University Affiliated Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Affiliated Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hejian Zou, doctor
Phone
13311881366
Email
mail@hjzou.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare
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