Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare (Gensci 048-203)

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 2

Conditions: Acute Gout; Gout Flare

Treatments: Drug: Colchicine; Drug: Genakumab for injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05936268

GenSci048-203

Details and patient eligibility

About

To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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. Start of acute gout flare within 3 days prior to enrolled;
5. History of ≥2 gout flare within 12 months prior to study start;
6. Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Genacumab group

Experimental group

Description:

Genakumab 200mg single injection

Treatment:

Drug: Genakumab for injection

cholchicine group

Active Comparator group

Description:

Colchicine 0.5mg qd po.for 12 weeks

Treatment:

Drug: Colchicine