A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202) (Gensci 048-202)

December 30, 2024 updated by: Changchun GeneScience Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Fudan University Affiliated Huashan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genakumab group
Genakumab 100mg single injection、Genakumab 200mg single injection
Drug: Genakumab for injection
150 mg/1ml/ vial
Active Comparator: Colchicine group
Oral colchicine 0.5mg once a day for 12 weeks
Drug: Colchicine
0.5 mg/table

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Number of Gout Flares Per Participant
Time Frame: Baseline to Week 12
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization
Time Frame: Baseline to Week 12
Baseline to Week 12
Time from Randomization to the First Flare
Time Frame: Baseline to Week 12
Baseline to Week 12
Mean duration of flares
Time Frame: Baseline to Week 12
Baseline to Week 12
5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline to Week 12
Baseline to Week 12

Other Outcome Measures

Outcome Measure
Time Frame
6. Immunogenic Outcome The incidence of anti-drug antibodies and the incidence of neutralizing antibody
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Collaborators

Huashan Hospital

Investigators

  • Principal Investigator: Hejian Zou, Fudan University Affiliated Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Actual)

January 19, 2024

Study Completion (Actual)

January 19, 2024

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenSci 048-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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