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

Phase 2RecruitingNCT06535412

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.218 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

218

Conditions

Systemic Lupus Erythematosus

Interventions

IMC-002 + SOCDRUG

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

Placebo + SOCDRUG

intravenous or subcutaneous injection of Placebo

IMM0306S + SOCDRUG

subcutaneous injection of 2.0 mg/kg，4.0 mg/kg and 6.0mg/kg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University People's Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

SLE Responder Index (SRI-4)

Proportion of patients achieving a response in SRI-4

Time frame: week 24

AEs and SAEs

The proportion of patients with AEs and SAEs

Time frame: week 52

Pharmacokinetics profiles

To characterize PK profiles and absolute bioavailability.

Time frame: week 52

Secondary Outcomes

SLE Responder Index (SRI-4)

Proportion of patients achieving a response in SRI-4

Time frame: week 12 and 52

Lupus Low Disease Activity State (LLDAS)

Proportion of patients achieving a response in LLDAS.

Time frame: week 24 and 52

Definition of Remission In SLE (DORIS)

Proportion of patients achieving a response in DORIS.

Time frame: week 24 and 52

SLEDAI-2000, PGA, BILAG-2004 and EQ-5D

Changes from baseline in SLEDAI-2000, PGA, BILAG-2004 and EQ-5D.

Time frame: 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.

Time frame: week 52

Achieve low level of urine protein

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.