Skip to main content
OpenTrials
Completed

NCT Number: NCT05328531

Clinical Study of Genakumab for Injection in Patients With Acute Gout

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Gout

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Genakumab for injection

Drug

150 mg/1ml/bottle

Placebo for Genakumab for Injection

Drug

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: baseline, 24hours, 48hours, 120hours, Day 7, Day 14, Day 21, Day 28, Day 56, Day 84, Day 112

    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  2. pain intensity change from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS)

    Time frame: 72 hours post-dose

    0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain

Secondary outcomes

  1. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: up to 16 weeks

    Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards

  2. High Sensitivity C-reactive Protein (hsCRP)

    Time frame: at 72 hours and 7 days, 4, 8 and 12 weeks post-dose

    High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (except Visit 2 and Visit 4 ) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.

Other outcomes

  1. Immunogenicity

    Time frame: baseline, Day 14, Day 28, Day 56, Day 84, Day 112

    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

  • Affiliated Hospital of Nantong University
  • Changhai Hospital
  • Hainan General Hospital
  • Huashan Hospital
  • Linyi People's Hospital
  • Shengjing Hospital
  • The First Affiliated Hospital with Nanjing Medical University
  • The Second Affiliated Hospital of Chongqing Medical University

Registry information

Official study title

The Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Genakumab for Injection in Patients With Acute Gout

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Feb 27, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.