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

NCT06535412 | Not Yet Recruiting Phase 1

• 1 other identifier: IMC002-S-01
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• SLE Responder Index (SRI-4)

  Proportion of patients achieving a response in SRI-4

  week 52

Secondary Outcomes (3)

• SLE Responder Index (SRI-4)

  week 24

• achieve and sustain a low dose of corticosteroid

  week 52

• achieve low level of urine protein

  week 52

Study Arms (2)

IMC-002 + SOC

EXPERIMENTAL

Drug: IMC-002 + SOC

Placebo + SOC

PLACEBO COMPARATOR

Drug: Placebo + SOC

Interventions

IMC-002 + SOC DRUG

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

IMC-002 + SOC

Placebo + SOC DRUG

intravenous injection of Placebo

Placebo + SOC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: October 10, 2024
• Primary Completion: December 10, 2025
• Study Completion (Estimated): June 10, 2026
• Last Updated: August 2, 2024

Record last verified: 2024-07