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

Phase 1

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: IMC-002 + SOC; Drug: Placebo + SOC

• Registration Number: NCT06535412
• Lead Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Brief 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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-08-02
• Last Update Posted: 2024-08-02
• Study Start: 2024-10-10
• Primary Completion: 2025-12-10
• Study Completion: 2026-06-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
• SLEDAI total score ≥ 6 at screening
• BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
• Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
• Other protocol defined inclusion criteria may apply.

Exclusion Criteria

• Active or unstable neuropsychiatric SLE or lupus nephritis
• Autoimmune or rheumatic disease other than SLE
• Significant, uncontrolled medical conditions not related to SLE
• Active and/or severe viral, bacterial or fungal infection
• History of malignancy within 5 years
• Other protocol defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMC-002 + SOC	IMC-002 + SOC	-
Placebo + SOC	Placebo + SOC	-

Primary Outcome Measures

Name	Time	Method
SLE Responder Index (SRI-4)	week 52	Proportion of patients achieving a response in SRI-4

Secondary Outcome Measures

Name	Time	Method
achieve low level of urine protein	week 52	Proportion of patients who achieve to reduce urine protein level
SLE Responder Index (SRI-4)	week 24	Proportion of patients achieving a response in SRI-4
achieve and sustain a low dose of corticosteroid	week 52	Proportion of patients who achieve or maintain prednisone \</= 7.5 mg/d or equivalent