A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

Acute Gout Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06169891
• Other study ID #: SSGJ-613-AG-III-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2023
• Est. completion date: November 2025

Study information

• Verified date: December 2023
• 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-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.

Description:

Study SSGJ-613-AG-III-01 is a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated, intolerant, or lack efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine. The entire treatment period is 48 weeks, consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 2025
• Est. primary completion date: December 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 =35 kg/m2.
• Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
• History of = 3 gout flares within the 12 months prior to study randomization.
• Onset of current acute gout flare within 4 days prior to study screening.
• Screening pain intensity of the Target Joint = 50 mm on the 0-100 mm VAS.
• Contraindicated, intolerant or lack efficacy to NSAIDs and/or colchicine.
• Accept uric acid lowering treatment according to the requirements of the protocol.

Exclusion Criteria:

• Gout caused by radiotherapy/chemotherapy, lead, organ transplantation, tumors, etc.
• Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
• Presence of severe renal function impairment.
• Intolerance of subcutaneous and intramuscular injection.
• Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment.
• History of malignant tumor within 5 years before screening.
• Live vaccinations within 8 weeks prior to the start of the study.
• Use of forbidden therapy.

Related Conditions & MeSH terms

• Acute Gout
• Arthritis, Gouty
• Gout

Intervention

Drug:
• Recombinant Anti-IL-1ß Humanized Monoclonal Antibody Injection 200 mg
one s.c. injection of SSGJ-613 once, on Day 1.

Other:
• Placebo
Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.

Drug:
• Compound Betamethasone Injection
1 mL i.m. once on Day 1

Other:
• Placebo
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)	The change in pain intensity from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).	72 hours post-dose
Primary	Time to First New Flare	The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares within 12 weeks after the first administration of each group, as well as the event incidence and 95% CI at 12 weeks.	12 weeks
Secondary	The Change in Pain Intensity in the Target Joint From Baseline to 6, 24, 48 Hours and 7 Days Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)	The change in pain intensity from baseline to 6, 12, 48 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).	At 6, 24, 48 hours and 7 Days post-dose
Secondary	The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint after study drug administration	The time to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).	Up to 48 weeks
Secondary	The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint after study drug administration	The time to complete pain remission in Pain intensity from baseline as measured by a 5-point Likert scale for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.	Up to 48 weeks
Secondary	Percentage of Participants with Complete Pain Remission of the Target Joint within 12 weeks after study drug administration	Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.	12 weeks
Secondary	Time to first use of Rescue Medication	The Kaplan Meier method was used to estimate the median time and 95% CI of the first use of Rescue Medication.	Within 7 days after the first administration, within 7 days after the last acute attack of gout during the double blind treatment period
Secondary	Percentage of Participants Taking Rescue Medication After Study Drug Administration and Categories and Dosages of Rescue Medication		12 weeks, 24 weeks, 48 weeks
Secondary	Likert scores for target joint pain	Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme).	7 days, 12 weeks, 24 weeks
Secondary	Time to First New Flare	The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares after the first administration of each group, as well as the event incidence and 95% CI.	24 weeks, 48 weeks
Secondary	Percentage of Participants with at least 1 new gout flare		12 weeks, 24 weeks, 48 weeks
Secondary	Number of new gout flares		12 weeks, 24 weeks, 48 weeks