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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06535412

Enrollment

218

Registered

2024-08-02

Start date

2024-10-10

Completion date

2026-06-10

Last updated

2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

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.

Interventions

DRUGIMC-002 + SOC

intravenous injection of 0.8mg/kg、1.2mg/kg and1.6mg/kg

DRUGPlacebo + SOC

intravenous injection of Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
SLE Responder Index (SRI-4)	week 52	Proportion of patients achieving a response in SRI-4

Secondary

Measure	Time frame	Description
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
achieve low level of urine protein	week 52	Proportion of patients who achieve to reduce urine protein level

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026