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

Gout Arthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270225
• Other study ID #: SSGJ-613-PGF-II-01
• Status: Recruiting
• Phase: Phase 2
• Start date: March 30, 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: Qinghong Zhou, MD
• Phone: +86 18911301578
• Email: zhouqinghong[@]3sbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Gouty
• Gout Arthritis

Intervention

Drug:
• Recombinant Anti-IL-1ß Humanized Monoclonal Antibody Injection 100 mg
Subjects will receive one s.c. injection of SSGJ-613 on Day 1.
• Recombinant Anti-IL-1ß Humanized Monoclonal Antibody Injection 200 mg
Subjects will receive one s.c. injection of SSGJ-613 on Day 1.
• Colchicine 0.5 mg
Subjects will receive 0.5mg/d Colchicine for 12 weeks.

Locations

Country	Name	City	State
China	Shanghai Huashan Hospital Fudan University-Rheumatology	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of acute gout flares		12 weeks
Secondary	Numbers of acute gout flares		24 weeks
Secondary	Proportions of subjects with at least 1 acute gout flare		12 weeks
Secondary	Proportions of subjects with at least 1 acute gout flare		24 weeks
Secondary	Time from randomization to first acute flare.		24 weeks
Secondary	Duration of acute gout flares.		12 weeks
Secondary	Duration of acute gout flares.		24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events (AE)		24 weeks