A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.

A Randomized, Open-label, Active-Controlled Phase II Trial to Evaluate the Efficacy and Safety of SSGJ-613 for Prophylaxis Against Acute Gouty Arthritis Flares in Subjects Initiating Urate-Lowering Treatment.

The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Gout Arthritis
• Intervention / Treatment: Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg; Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg; Drug: Colchicine 0.5 mg

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Shanghai Huashan Hospital Fudan University-Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must be 18 Years to 75 Years, both male and female.
• BMI ≤40 kg/m2.
• Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis.
• ≥2 acute gout flares within 1 year prior to screening.
• Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration.

Exclusion Criteria:

• Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc.
• Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
• Presence of severe renal function impairment.
• Intolerance of subcutaneous injection.
• Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment.
• Live vaccinations within 8 weeks prior to the start of the study.
• Use of forbidden therapy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SSGJ-613 100 mg; Subjects will receive 100mg SSGJ-613 on Day 1.	Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg; Subjects will receive one s.c. injection of SSGJ-613 on Day 1.; Other Names: SSGJ-613 100mg
Experimental: SSGJ-613 200 mg; Subjects will receive 200mg SSGJ-613 on Day 1.	Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg; Subjects will receive one s.c. injection of SSGJ-613 on Day 1.; Other Names: SSGJ-613 200mg
Active Comparator: Colchicine 0.5mg; Subjects will receive 0.5mg/d Colchicine for 12 weeks.	Drug: Colchicine 0.5 mg; Subjects will receive 0.5mg/d Colchicine for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Numbers of acute gout flares	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of acute gout flares		24 weeks
Proportions of subjects with at least 1 acute gout flare		12 weeks
Proportions of subjects with at least 1 acute gout flare		24 weeks
Time from randomization to first acute flare.		24 weeks
Duration of acute gout flares.		12 weeks
Duration of acute gout flares.		24 weeks
Subject's overall assessment of response to treatment	Response to treatment will be assessed by the subjects using a five-point Likert scale: 1-very good, 2-good, 3-fair, 4-poor, and 5-very poor.	24 weeks
Investigator's overall assessment of response to treatment	Response to treatment will be assessed by the Investigators using a five-point Likert scale: 1-very good, 2-good, 3-fair, 4-poor, and 5-very poor.	24 weeks
36-item Short Form Survey (SF-36)	36-Item Short Form Survey (SF-36) will be used to assess the health and functional changes of the subjects. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health.	24 weeks
Adverse events (AE)		24 weeks

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Investigators: Principal Investigator: Hejian Zou, MD, Shanghai Huashan Hospital Fudan University-Rheumatology; Study Director: Qinghong Zhou, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis; Arthritis, Gouty; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Colchicine
• Other Study ID Numbers: SSGJ-613-PGF-II-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No