Clinical Study of Genakumab for Injection in Patients With Acute Gout
NCT ID: NCT05328531
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
121 participants
INTERVENTIONAL
2021-05-22
2022-06-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
NCT05936281
Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare
NCT05936268
Rasburicase Treatment in Chronic Gouty Arthritis
NCT05312268
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
NCT06298071
A Phase Ib/II Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
NCT05588908
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Phase II: randomized, double-blind, active control design.There are 2 dose groups of Genakumab for Injection with 30 participant s in each group and 1 group of Compound Betamethasone Injection with 30 praticipants.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Genakumab for injection 50mg (Ib)
subcutaneous injection, single dose
Genakumab for Injection
150 mg/1ml/bottle
Genakumab for injection 100mg (Ib)
subcutaneous injection, single dose
Genakumab for Injection
150 mg/1ml/bottle
Genakumab for injection 195mg (Ib)
subcutaneous injection, single dose
Genakumab for Injection
150 mg/1ml/bottle
Genakumab for injection 100mg (II)
Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
Genakumab for Injection
150 mg/1ml/bottle
Genakumab for injection 195mg (II)
Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
Genakumab for Injection
150 mg/1ml/bottle
Compound Betamethasone Injection 1ml (II)
Compound Betamethasone Injection, 1 ml, intramuscular injection, single dose Placebo for Genakumab for injection, 100mg, subcutaneous injection, single dose
Placebo for Genakumab for Injection
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Genakumab for Injection
150 mg/1ml/bottle
Placebo for Genakumab for Injection
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of acute arthritis of primary gout
* Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
* Body mass index of less than or equal to 45 kg/m2
* Onset of current acute gout flare within 5 days prior to study entry
* Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
* History of gout flare prior to study entry
Exclusion Criteria
* Presence of severe renal function impairment
* Use of specified pain relief medications or biologics ( corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor) within specified periods prior to study entry
* Live vaccinations within 3 months prior to randomization
* Requirement for administration of antibiotics against latent tuberculosis (TB)
* Any active or recurrent bacterial, fungal, or viral infection
* QTc\>450ms for male, QTc\>470ms for female
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Huashan Hospital
OTHER
Hainan General Hospital
OTHER
Linyi People's Hospital
OTHER
The Second Affiliated Hospital of Chongqing Medical University
OTHER
Changhai Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Shengjing Hospital
OTHER
Affiliated Hospital of Nantong University
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hejian Zou
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Jing Zhang
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital of Fudan Univeisity
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Gensci048GA-Ib/II
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.