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

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • IMC-002 + SOC

    Drug

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

  • Placebo + SOC

    Drug

    intravenous or subcutaneous injection of Placebo

  • IMM0306S + SOC

    Drug

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

Treatment groups

218 Participants
are divided into 3 treatment groups
Group A: IMC-002 + SOCExperimental treatment 1 intervention
Group B: Placebo + SOCPlacebo comparator 1 intervention
Group C: IMM0306S + SOCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

SLE Responder Index (SRI-4)

Proportion of patients achieving a response in SRI-4

Time frame
week 24
2

AEs and SAEs

The proportion of patients with AEs and SAEs

Time frame
week 52
3

Pharmacokinetics profiles

To characterize PK profiles and absolute bioavailability.

Time frame
week 52

Secondary outcomes

1

SLE Responder Index (SRI-4)

Proportion of patients achieving a response in SRI-4

Time frame
week 12 and 52
2

Lupus Low Disease Activity State (LLDAS)

Proportion of patients achieving a response in LLDAS.

Time frame
week 24 and 52
3

Definition of Remission In SLE (DORIS)

Proportion of patients achieving a response in DORIS.

Time frame
week 24 and 52
4

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

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

Time frame
week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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