Cutaneous Lupus Erythematosus (CLE)
Conditions
Brief summary
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).
Interventions
DRUGICP-488 Tablets
Patients will receive ICP-488 orally as per the protocol
OTHERICP-488 Placebo
Patients will receive ICP-488 Placebo orally as per the protocol.
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 and ≤75 years. 2. Diagnosed with cutaneous lupus erythematosus (CLE) for at least 3 months before the screening visit. 3. Biopsy-proven histologically consistent with discoid lupus erythematosus (DLE) and/or subacute cutaneous lupus erythematosus (SCLE). 4. CLASI activity (CLASI-A) score ≥8 at both the screening and baseline (Day 1) visits. 5. May have concomitant systemic lupus erythematosus (SLE) or not. 6. The treatment regimen is stable and can be maintained until the end of the study treatment. 7. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the first dose on Day 1. 8. Women of childbearing potential (WOCBP) and male subjects must agree to use highly effective contraceptive methods throughout the study treatment period and for one month (28 days) after the last dose
Exclusion criteria
1. Specific cutaneous lupus erythematosus subtypes: acute cutaneous lupus erythematosus (ACLE), tumid lupus, lupus panniculitis (deep lupus), chilblain lupus. 2. Patients with drug-induced cutaneous lupus erythematosus and/or drug-induced systemic lupus erythematosus. 3. 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. 5\. Other autoimmune diseases except for secondary Sjögren's syndrome. 6. Concurrent herpes zoster infection at screening or before dosing on Day 1, or a history of severe herpes zoster or severe herpes simplex infection. 7\. Positive Hepatitis B surface Antigen (HBsAg) at screening; or abnormal Hepatitis B Virus (HBV)Deoxyribonucleic Acid (DNA) Polymerase Chain Reaction (PCR) test result in subjects positive for Hepatitis B core Antibody (HBcAb). 8 Evidence of active, latent, or inadequately treated mycobacterium tuberculosis (TB) infection. 9.Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol. 10\. Inadequate organ function levels, including abnormalities in hematology, liver function, renal function, coagulation function, cardiac function, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16. | All the subjects completed the 16-week assessment. |
Secondary
| Measure | Time frame |
|---|---|
| At each visit, the proportion of subjects whose CLASI-A score improved by ≥50% compared to the baseline value (CLASI-50). | From baseline to week 28 |
| 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. | From baseline to week 28 |
| The average change of the CLASI-A score from the baseline value at each visit. | From baseline to week 28 |
| The percentage change of CLASI-A relative to the baseline at each visit. | From baseline to week 28 |
| Adverse events that occurred during treatment. | From baseline to week 28 |
| The incidence of clinical abnormalities such as laboratory test results, electrocardiogram (ECG), and vital signs, and the changes relative to the baseline. | From baseline to week 28 |
| Maximum Concentration at Steady State(Cmax,ss) | From baseline to week 12 |
| Steady-State Time to Maximum | From baseline to week 12 |
| Area under the curve (AUC) | From baseline to week 12 |
Countries
China
Contacts
CONTACTAlexia Lu
Outcome results
None listed