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

The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: IMC-002 + SOC; Drug: Placebo + SOC; Drug: IMM0306S + SOC

Detailed Description

This two-stage study consists of a multicenter dose-escalation study（Phase Ib）and a multicenter randomized, double-blind, placebo-controlled study（Phase II）.

Primary objectives of the dose-finding stage: 1) Evaluate the efficacy, safety, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of intravenous IMC-002 and subcutaneous IMM0306S in adult patients with active systemic lupus erythematosus (SLE); 2) Determine the absolute bioavailability of subcutaneous IMM0306S relative to intravenous IMC-002 in adults with moderate-to-severe active SLE; 3) Select the recommended Phase II dose (RP2D).

Primary objectives of the proof-of-concept (PoC) stage: Compare the efficacy of 1.2 mg/kg or 1.6 mg/kg IMC-002 versus placebo in adults with moderate-to-severe active SLE, and assess the efficacy and population PK (popPK) profiles of IMM0306S in patients with active SLE.

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Peking University People's Hospital; Phone Number: +86 010-88324516; Email: pkuphiao@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
• SLEDAI-2000 score ≥8. For screening eligibility only, headache and fever items shall be excluded from SLEDAI-2K scoring. Skin lesions shall meet morphological and distributive characteristics of active cutaneous lupus, with a total active Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) score ≥2.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMC-002 + SOC	Drug: IMC-002 + SOC; intravenous injection of 0.8mg/kg、1.2mg/kg and1.6mg/kg; Other Names: IMM0306
Placebo Comparator: Placebo + SOC	Drug: Placebo + SOC; intravenous or subcutaneous injection of Placebo
Experimental: IMM0306S + SOC	Drug: IMM0306S + SOC; subcutaneous injection of 2.0 mg/kg，4.0 mg/kg and 6.0mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLE Responder Index (SRI-4)	Proportion of patients achieving a response in SRI-4	week 24
AEs and SAEs	The proportion of patients with AEs and SAEs	week 52
Pharmacokinetics profiles	To characterize PK profiles and absolute bioavailability.	week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLE Responder Index (SRI-4)	Proportion of patients achieving a response in SRI-4	week 12 and 52
Lupus Low Disease Activity State (LLDAS)	Proportion of patients achieving a response in LLDAS.	week 24 and 52
Definition of Remission In SLE (DORIS)	Proportion of patients achieving a response in DORIS.	week 24 and 52
SLEDAI-2000, PGA, BILAG-2004 and EQ-5D	Changes from baseline in SLEDAI-2000, PGA, BILAG-2004 and EQ-5D.	week 52
Achieve and sustain a low dose of corticosteroid	Changes in corticosteroid dosage at each visit and proportion of patients who achieve or maintain prednisone ≤ 7.5 mg/d.	week 52
Achieve low level of urine protein	Changes in 24-hour urinary protein at each visit among trial patients with elevated 24-hour urinary protein at baseline (≥0.5 g) and proportion of patients who achieve to reduce urine protein level.	week 52
Immunogenicity profiles	Positive rate and titers of anti-drug antibodies (ADA); neutralizing antibodies (NAb) may be further evaluated.	week 52
Serologic laboratory parameters	Changes from baseline in serologic laboratory parameters (antinuclear antibodies, anti-ds-DNA antibodies, complement C3 and C4).	week 52
Pharmacodynamic (PD) assessments and biomarker evaluations	Changes in TBNK subsets (CD3, CD4, CD56, CD16, Treg, etc.), B-cell subsets (CD19, CD20, CD27, CD38, CD24, etc.), IL-6 and IgG.	week 52

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): December 17, 2028
• Study Completion (Estimated): December 17, 2028

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: Immuneonco Biotech company

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No