NCT06535412

A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus

A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of active SLE.

Detailed description

This is a phase Ib/II study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg and 1.6mg/kg dose level, Phase II study is a multi-center, randomized, double-blind, placebo control study to evaluate the safety and efficacy of IMC-002 in active Systemic Lupus Erythematosus patients.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	IMC-002 + SOC	intravenous injection of 0.8mg/kg、1.2mg/kg and1.6mg/kg
DRUG	Placebo + SOC	intravenous injection of Placebo

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-12-10
• Completion: 2026-06-10
• First posted: 2024-08-02
• Last updated: 2024-08-02