Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare (Gensci 048-203)

November 6, 2024 updated by: Changchun GeneScience Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

106

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. 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)

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: Genacumab group
Genakumab 200mg single injection
Drug: Genakumab for injection
150 mg/1ml/bottle
Active Comparator: cholchicine group
Colchicine 0.5mg qd po.for 12 weeks
Drug: Colchicine
0.5mg/table

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
72hours target joint VAS change from baseline
Time Frame: 72h±2h
72hours target joint VAS change from baseline
72h±2h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6hours, 24hours, 48hours, 72hours, Day 8,
Recurrence of flare
Time Frame: 12 weeks after the last dose
Proportion of patients who have at least 1 flare Time to first flare
12 weeks after the last dose
Safety outcome
Time Frame: 12weeks
AE, laboratory examination, ECG, vital signs and physical examination
12weeks
immunogenic outcome
Time Frame: 12 weeks after the last dose
The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
12 weeks after the last dose

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 21, 2023

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 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 (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenSci048-203

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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