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Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study

ConditionCutaneous Lupus Erythematosus (CLE)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

About this trial

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in subjects with cutaneous lupus erythematosus (CLE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 and ≤75 years.

Diagnosed with cutaneous lupus erythematosus (CLE) for at least 3 months before the screening visit.

Biopsy-proven histologically consistent with discoid lupus erythematosus (DLE) and/or subacute cutaneous lupus erythematosus (SCLE).

CLASI activity (CLASI-A) score ≥8 at both the screening and baseline (Day 1) visits.

Disqualifiers

Specific cutaneous lupus erythematosus subtypes: acute cutaneous lupus erythematosus (ACLE), tumid lupus, lupus panniculitis (deep lupus), chilblain lupus.

Patients with drug-induced cutaneous lupus erythematosus and/or drug-induced systemic lupus erythematosus.

Subjects with active kidney disease 4．Other inflammatory joint or skin diseases or overlap syndrome not caused by systemic lupus erythematosus (SLE) as the primary disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ICP-488 Tablets

    Drug

    Patients will receive ICP-488 orally as per the protocol

  • ICP-488 Tablets

    Drug

    Patients will receive ICP-488 orally as per the protocol

  • ICP-488 Placebo

    Other intervention

    Patients will receive ICP-488 Placebo orally as per the protocol.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: ICP-488 Dose AExperimental treatment 1 intervention
Group B: ICP-488 Dose BExperimental treatment 1 intervention
Group C: ICP-488 PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16.

Time frame
All the subjects completed the 16-week assessment.

Secondary outcomes

1

At each visit, the proportion of subjects whose CLASI-A score improved by ≥50% compared to the baseline value (CLASI-50).

Time frame
From baseline to week 28
2

The proportion of subjects with disease improvement as defined by a reduction of ≥4 points relative to the baseline value of CLASI-A （CLASI ≥ 4）at each visit.

Time frame
From baseline to week 28
3

The average change of the CLASI-A score from the baseline value at each visit.

Time frame
From baseline to week 28
4

The percentage change of CLASI-A relative to the baseline at each visit.

Time frame
From baseline to week 28

Other outcomes

Sponsors and contacts

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

Beijing InnoCare Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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