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

Sunshine Guojian Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Acute Gout

Treatments: Other: Placebo; Drug: Compound Betamethasone Injection; Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06169891

SSGJ-613-AG-III-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups

SSGJ-613 200 mg

Experimental group

Description:

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.

Treatment:

Other: Placebo

Other: Placebo

Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg

Compound Betamethasone Injection 1 mL

Active Comparator group

Description:

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.

Treatment:

Other: Placebo

Other: Placebo

Drug: Compound Betamethasone Injection