Back to resultsSafety and Efficacy of Genakumab for Injection in Patients With Gout Initiating Urico-lowering Therapy (Gensci 048-202)
Primary Purpose
Acute Gout, Gout Initiating Urico-lowering Therapy
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Genakumab for injection
Etoricorxib
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gout focused on measuring Acute gout, urico-lowering therapy
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; History of ≥2 gout flare within 12 months prior to study start; Initiate uric-lowering therapy or initiated uric-lowering therapy within 1 week prior to screening
Sites / Locations
- Fudan University Affiliated Huashan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Genakumab group
Colchicine group
Arm Description
Genakumab 100mg single injection,Genakumab 200mg single injection
Colchicine 0.5mg qd po.for 12 weeks
Outcomes
Primary Outcome Measures
The number of acute episodes of gout in 12 weeks
Secondary Outcome Measures
Proportion of subjects with at least one acute episode within 12 weeks
Random to the time of the first acute onset
Duration of acute gout attacks over a 12-week period
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
immunogenic outcome
The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
Full Information
NCT ID
NCT05936281
First Posted
June 30, 2023
Last Updated
June 30, 2023
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Huashan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05936281
Brief Title
Safety and Efficacy of Genakumab for Injection in Patients With Gout Initiating Urico-lowering Therapy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet 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 initiating urico-lowering therapy
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gout, Gout Initiating Urico-lowering Therapy
Keywords
Acute gout, urico-lowering therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Acute gout patients initiating urico-lowering therapy Group A: Genakumab 100mg single injection; Group B: Genakumab 200mg single injection;Group C: Colchicine 0.5mg qd po.for 12 weeks
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Genakumab group
Arm Type
Experimental
Arm Description
Genakumab 100mg single injection,Genakumab 200mg single injection
Arm Title
Colchicine 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)
Etoricorxib
Intervention Description
60mg/table
Primary Outcome Measure Information:
Title
The number of acute episodes of gout in 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with at least one acute episode within 12 weeks
Time Frame
12 weeks
Title
Random to the time of the first acute onset
Time Frame
12 weeks
Title
Duration of acute gout attacks over a 12-week period
Time Frame
12 weeks
Title
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
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
Time Frame
12 weeks
Title
immunogenic outcome
Description
The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
Time Frame
12 weeks
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;
History of ≥2 gout flare within 12 months prior to study start;
Initiate uric-lowering therapy or initiated uric-lowering therapy within 1 week prior to screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Si Li
Phone
18301941524
Email
lijingsi@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
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 Initiating Urico-lowering Therapy
We'll reach out to this number within 24 hrs