NCT05588908

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

A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the target dose of phase II and to evaluate the safety, tolerability, pharmacokinetics and efficacy of recombinant anti-IL-1β humanized monoclonal antibody injection at different doses in Chinese participants with acute gout.

Detailed description

The phase Ib study is a multi-center, open label, dose escalation study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection and to determine the target dose of phase II for the treatment of acute flare in Chinese gout patients in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. There are 3 dose groups (100 mg、200 mg and 300 mg) in phase Ib and 10 participants in each group. The phase II study is a dose-ranging, multi-center, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of 2 dose regimens (200 mg and 300 mg, based on the outcome of phase Ib) of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection for the treatment of acute flare in Chinese gout patients in whom NSAIDs and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. The phase II recommended dose of SSGJ-613 in subjects with acute gouty was determined according to the phase Ib interim analysis results.

Conditions

• Acute Gout

Interventions

Type	Name	Description
DRUG	Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)	100 mg subcutaneous (s.c) once
DRUG	Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)	200 mg subcutaneous (s.c) once
DRUG	Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)	300 mg subcutaneous (s.c) once
DRUG	Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)	one s.c. injection of SSGJ-613 once, on Day 1.
DRUG	Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)	one s.c. injection of SSGJ-613 once, on Day 1.
DRUG	Compound Betamethasone Injection (phase II)	1 mL i.m. once on Day 1
OTHER	Placebo (phase II)	Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.

Timeline

• Start date: 2022-06-29
• Primary completion: 2023-09-01
• Completion: 2023-11-01
• First posted: 2022-10-20
• Last updated: 2022-10-20

Locations

3 sites across 1 country: China