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Completed

NCT Number: NCT05936281

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

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

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Initiating Urate-loweringUrate-lowering Therapy Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

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

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Genakumab for injection

Drug

150 mg/1ml/ vial

Colchicine

Drug

0.5 mg/table

Primary outcomes

  1. Mean Number of Gout Flares Per Participant

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization

    Time frame: Baseline to Week 12

  2. Time from Randomization to the First Flare

    Time frame: Baseline to Week 12

  3. Mean duration of flares

    Time frame: Baseline to Week 12

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

    Time frame: Baseline to Week 12

Other outcomes

  1. 6. Immunogenic Outcome The incidence of anti-drug antibodies and the incidence of neutralizing antibody

    Time frame: Baseline to Week 12

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-controlled Phase 2 Study for Evaluating Efficacy and Safety of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering

Acronym: Gensci 048-202

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2023
Registry last updated
Jan 1, 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.

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