Gensci 048-202: Safety and Efficacy of Genakumab for Injection in Patients With Gout Initiating Urico-lowering Therapy
Study Details
Study Description
Brief Summary
To evaluate the safety and efficacy of Genakumab for Injection in patients with gout initiating urico-lowering therapy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Genakumab group Genakumab 100mg single injection,Genakumab 200mg single injection |
Drug: Genakumab for injection
150 mg/1ml/bottle
|
| Active Comparator: Colchicine group Colchicine 0.5mg qd po.for 12 weeks |
Drug: Etoricorxib
60mg/table
|
Outcome Measures
Primary Outcome Measures
- The number of acute episodes of gout in 12 weeks [12 weeks]
Secondary Outcome Measures
- Proportion of subjects with at least one acute episode within 12 weeks [12 weeks]
- Random to the time of the first acute onset [12 weeks]
- Duration of acute gout attacks over a 12-week period [12 weeks]
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [12 weeks]
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 [12 weeks]
The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Affiliated Huashan Hospital | Shanghai | Shanghai | China | 200030 |
Sponsors and Collaborators
- GeneScience Pharmaceuticals Co., Ltd.
- Huashan Hospital
Investigators
- Principal Investigator: Hejian Zou, Fudan University Affiliated Huashan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GenSci 048-202