- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270225
A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.
April 9, 2024 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
150
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 Contact
- Name: Qinghong Zhou, MD
- Phone Number: +86 18911301578
- Email: zhouqinghong@3sbio.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200040
- Recruiting
- Shanghai Huashan Hospital Fudan University-Rheumatology
-
Contact:
- Hejian Zou, MD
- Phone Number: +86 13311881366
- Email: hjzou@fudan.edu.cn
-
Principal Investigator:
- Hejian Zou
-
-
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
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
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: SSGJ-613 100 mg
Subjects will receive 100mg SSGJ-613 on Day 1.
|
Subjects will receive one s.c.
injection of SSGJ-613 on Day 1.
Other Names:
|
Experimental: SSGJ-613 200 mg
Subjects will receive 200mg SSGJ-613 on Day 1.
|
Subjects will receive one s.c.
injection of SSGJ-613 on Day 1.
Other Names:
|
Active Comparator: Colchicine 0.5mg
Subjects will receive 0.5mg/d Colchicine for 12 weeks.
|
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
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numbers of acute gout flares
Time Frame: 24 weeks
|
24 weeks
|
|
Proportions of subjects with at least 1 acute gout flare
Time Frame: 12 weeks
|
12 weeks
|
|
Proportions of subjects with at least 1 acute gout flare
Time Frame: 24 weeks
|
24 weeks
|
|
Time from randomization to first acute flare.
Time Frame: 24 weeks
|
24 weeks
|
|
Duration of acute gout flares.
Time Frame: 12 weeks
|
12 weeks
|
|
Duration of acute gout flares.
Time Frame: 24 weeks
|
24 weeks
|
|
Subject's overall assessment of response to treatment
Time Frame: 24 weeks
|
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
Time Frame: 24 weeks
|
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)
Time Frame: 24 weeks
|
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)
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
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)
March 30, 2024
Primary Completion (Estimated)
June 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 (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 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
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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