Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare

NCT05936268 | Completed Phase 2

• 1 other identifier: GenSci048-203
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Gout; Gout Flare

Keywords

Acute gout; Gout flare

Outcome Measures

Primary Outcomes (1)

• 72hours target joint VAS change from baseline

  72hours target joint VAS change from baseline

  72h±2h

Secondary Outcomes (4)

• Pain intensity

  6hours, 24hours, 48hours, 72hours, Day 8,

• Recurrence of flare

  12 weeks after the last dose

• Safety outcome

  12weeks

• immunogenic outcome

  12 weeks after the last dose

Study Arms (2)

Genacumab group

EXPERIMENTAL

Genakumab 200mg single injection

Drug: Genakumab for injection

cholchicine group

ACTIVE COMPARATOR

Colchicine 0.5mg qd po.for 12 weeks

Drug: Colchicine

Interventions

Genakumab for injection DRUG

150 mg/1ml/bottle

Genacumab group

Colchicine DRUG

0.5mg/table

cholchicine group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Huashan Hospital: collaborator

Study Sites (1)

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• Kong N, Xue Y, Mao L, Qian L, Guo H, Hu J, Yuan F, Li R, Duan X, Yu J, Gou W, Yang L, Wei H, Li R, Xu Q, Luo T, Zhang X, Zou H. Efficacy and Safety of Firsekibart Compared to Etoricoxib for Gout Flares: A Phase 2, Multicenter, Open-label, Active-controlled, Randomized Non-inferiority Trial. Rheumatol Ther. 2025 Oct;12(5):975-990. doi: 10.1007/s40744-025-00790-6. Epub 2025 Aug 20.

  PMID: 40833487 DERIVED

MeSH Terms

Interventions

Injections; Colchicine

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Alkaloids; Heterocyclic Compounds

Study Officials

• Hejian Zou

  Fudan University Affiliated Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Acute gout patients with gout flare Group A: Genakumab 200mg single injection;Group B: Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days)

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 7, 2023
• Study Start: July 21, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

CN (1)