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OpenTrials
Completed

NCT Number: NCT05936268

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

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

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Key information

Conditions

Acute Gout Gout Flare

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genakumab for injection

Drug

150 mg/1ml/bottle

Colchicine

Drug

0.5mg/table

Primary outcomes

  1. 72hours target joint VAS change from baseline

    Time frame: 72h±2h

    72hours target joint VAS change from baseline

Secondary outcomes

  1. Pain intensity

    Time frame: 6hours, 24hours, 48hours, 72hours, Day 8,

    target joint VAS Target joint VAS change from baseline Time to first VAS<=50% baseline VAS Time to first VAS<=30mm Time to first VAS<=10mm

  2. Recurrence of flare

    Time frame: 12 weeks after the last dose

    Proportion of patients who have at least 1 flare Time to first flare

  3. Safety outcome

    Time frame: 12weeks

    AE, laboratory examination, ECG, vital signs and physical examination

  4. immunogenic outcome

    Time frame: 12 weeks after the last dose

    The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Huashan Hospital

Registry information

Official study title

A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare

Acronym: Gensci 048-203

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2023
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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