Clinical Study of Genakumab for Injection in Patients With Acute Gout

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Gout

Treatments: Drug: Genakumab for Injection; Drug: Placebo for Genakumab for Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05328531

Gensci048GA-Ib/II

Details and patient eligibility

About

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout

Full description

Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose groups with 10 participant s in each group.

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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years ≤ age ≤65 years
• 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

• evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 6 patient groups

Genakumab for injection 50mg (Ib)

Experimental group

Description:

subcutaneous injection, single dose

Treatment:

Drug: Genakumab for Injection

Genakumab for injection 100mg (Ib)

Experimental group

Description:

subcutaneous injection, single dose

Treatment:

Drug: Genakumab for Injection

Genakumab for injection 195mg (Ib)

Experimental group

Description:

subcutaneous injection, single dose

Treatment:

Drug: Genakumab for Injection

Genakumab for injection 100mg (II)

Experimental group

Description:

Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose

Treatment:

Drug: Genakumab for Injection

Genakumab for injection 195mg (II)

Experimental group

Description:

Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose

Treatment:

Drug: Genakumab for Injection

Compound Betamethasone Injection 1ml (II)

Active Comparator group

Description:

Compound Betamethasone Injection, 1 ml, intramuscular injection, single dose Placebo for Genakumab for injection, 100mg, subcutaneous injection, single dose

Treatment:

Drug: Placebo for Genakumab for Injection