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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Gout
• Intervention / Treatment: Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg; Other: Placebo; Other: Placebo; Drug: Compound Betamethasone Injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qinghong Zhou, MD; Phone Number: +86 18911301578; Email: zhouqinghong@3sbio.com

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 ≤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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SSGJ-613 200 mg; SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.	Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg; one s.c. injection of SSGJ-613 once, on Day 1.; Other Names: SSGJ-613 200 mg; Other: Placebo; Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.; Other Names: 0.9% sodium chloride injection; Other: Placebo; Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.; Other Names: PBO
Active Comparator: Compound Betamethasone Injection 1 mL; Compound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1.	Other: Placebo; Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.; Other Names: 0.9% sodium chloride injection; Other: Placebo; Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.; Other Names: PBO; Drug: Compound Betamethasone Injection; 1 mL i.m. once on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Percentage of Participants Taking Rescue Medication After Study Drug Administration and Categories and Dosages of Rescue Medication		12 weeks, 24 weeks, 48 weeks
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
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
Percentage of Participants with at least 1 new gout flare		12 weeks, 24 weeks, 48 weeks
Number of new gout flares		12 weeks, 24 weeks, 48 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis, Gouty; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Antibodies; Betamethasone; Antibodies, Monoclonal
• Other Study ID Numbers: SSGJ-613-AG-III-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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