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

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: IMC-002 + SOC; Drug: Placebo + SOC

Study type: Interventional

Funder types: Other

Identifiers

NCT06535412

IMC002-S-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 218 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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218 participants in 2 patient groups, including a placebo group

IMC-002 + SOC

Experimental group

Treatment:

Drug: IMC-002 + SOC

Placebo + SOC

Placebo Comparator group

Treatment:

Drug: Placebo + SOC