A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202) (Gensci 048-202)

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 2

Conditions: Gout Initiating Urate-loweringUrate-lowering Therapy; Gout

Treatments: Drug: Genakumab for injection; Drug: Colchicine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05936281

GenSci 048-202

Details and patient eligibility

About

To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering

Full description

A randomized, open-lable, multi-center, active-controlled Phase 2 study. Patients are randomized to Genakumab 100mg single injection group, Genakumab 200mg single injection group or oral colchicine 0.5mg once a day.for 12 weeks group.

Enrollment: 165 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Signed written informed consent before any study procedure is performed.
2. Male or female, 18 years ≤ age ≤ 75 years.
3. BMI ≤ 40kg/m2.
4. Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of arthritis of primary gout.
5. History of ≥2 gout flare within 12 months prior to screening.
6. Willingness to initiate urate-lowering therapy or having initiated urate-lowering therapy within 1 week prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

Genakumab group

Experimental group

Description:

Genakumab 100mg single injection、Genakumab 200mg single injection

Treatment:

Drug: Genakumab for injection

Colchicine group

Active Comparator group

Description:

Oral colchicine 0.5mg once a day for 12 weeks

Treatment:

Drug: Colchicine