Active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE)
Conditions
Interventions
Placebo group:Oral placebo
ICP-488 6 mg BID:Take 6 mg of ICP-488
ICP-488 3 mg BID:Take 3 mg of ICP-488
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Before starting any screening or conducting specific research procedures, the subjects must voluntarily sign the informed consent form and indicate the date. 2. Male or female subjects aged 18 years or older and 75 years or younger who have been diagnosed with cutaneous lupus erythematosus (CLE) for at least 3 months before the screening visit (if the patient has no histological confirmation of CLE type as DLE or SCLE before the screening visit, the investigator before the screening visit needs to judge based on the available data whether the main diagnosis is more likely to be DLE or SCLE), with or without systemic lupus erythematosus manifestations. 3. Previous or during the screening period, there must be a histologically confirmed diagnosis of discoid lupus erythematosus (DLE) and/or subacute cutaneous lupus erythematosus (SCLE) (with or without systemic manifestations), and the skin lesions at the screening visit should be recorded through skin photography and the relevant diagnostic manifestations should be verified. 4. The subjects must have a histologically confirmed diagnosis of discoid lupus erythematosus (DLE) and/or subacute cutaneous lupus erythematosus (SCLE) during the previous or during the screening period (with or without systemic manifestations), and the diagnosis should be confirmed at the screening visit through skin photography. 5. The subjects must have a CLASI-A score of =8 at the screening period and the baseline visit (day 1). 6. The subjects can have or not have systemic lupus erythematosus (SLE), and the proportion of SLE patients in the study population should not exceed 50%. The SLE diagnosis is based on the criteria of the International Collaborative Group on Systemic Lupus Erythematosus (SLICC) in 2012 (Petri M 2012), and/or =4 items of the ACR classification criteria (Hochberg 1997) and/or the EULAR/ACR 2019 classification criteria (Aringer 2019). 7. The treatment plan is stable and can continue until the end of the study treatment (week 24), including one or more of the following drugs: • Oral corticosteroids (at least 6 weeks before randomization, with a stable dose for at least 2 weeks and a dose not exceeding 15 mg/day prednisone [or its equivalent]) • Topical calcineurin inhibitors (at least 12 weeks before randomization, with a stable dose for at least 4 weeks) • Oral antimalarial drugs (at least 12 weeks before randomization, with a stable dose for at least 4 weeks, and the dose before randomization should not exceed the maximum dose listed here for antimalarial drugs [400 mg/day hydroxychloroquine, 250 mg/day chloroquine, 100 mg/day quinacrine or 100 mg/day mepacrine]) • Oral immunosuppressants (methotrexate, mycophenolate mofetil/mycophenolic acid [MMF/MPA], azathioprine, sulfasalazine, tacrolimus, leflunomide, dapsone or retinoic acid; at least 12 weeks before randomization, with a stable dose for at least 4 weeks). 8. If the subjects receive non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics, the dose must be stable within 2 weeks before screening and throughout the treatment period. 9. There must be a record indicating that at least 12 weeks of use (treatment can be continuous or cumulative) after the random administration has shown no therapeutic effect and/or there is a record indicating that the antimalarial drug was discontinued due to poor tolerance and/or side effects. 10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at the screen
Exclusion criteria
Exclusion criteria: The subjects will be excluded if they meet any of the following criteria: 1. Criteria related to the target disease: a) Subjects with any of the following specific subtypes of cutaneous lupus erythematosus: acute cutaneous lupus erythematosus (ACLE), edematous lupus, lupus chorioangiitis (deep lupus), chilblain-like lupus. b) Patients with drug-induced cutaneous lupus erythematosus and/or drug-induced systemic lupus erythematosus. c) Subjects with active kidney disease, defined as a screening period estimated glomerular filtration rate (eGFR) 0.5 g/24 hours or random urine protein/creatinine ratio (UPCR) > 56.5 mg/mmol (500 mg/g). d) Subjects with antiphospholipid antibody syndrome within 1 year before the screening visit, or subjects with unexplained pregnancy loss. Subjects with a history of 3 or more consecutive unexplained pregnancy losses and suspected to be caused by antiphospholipid syndrome (APS). e) Subjects with active severe or unstable neuro-psychiatric systemic lupus erythematosus, including but not limited to: sterile meningitis, vasculitis of the brain, myelopathy, demyelinating syndrome (ascending, transverse, acute inflammatory demyelinating polyneuropathy), acute confusion state, disturbance of consciousness level, psychosis, acute stroke or stroke syndrome, cranial nerve lesion, epilepsy status, cerebellar ataxia, multiple mononeuritis. 2. Other medical disease, condition or history-related exclusion criteria: a) Any active skin disease other than CLE may interfere with the research assessment of CLE, including but not limited to psoriasis, non-LE alopecia areata, erythema multiforme, leg ulcers, etc. b) Patients with other inflammatory joint or skin diseases caused by non-systemic lupus erythematosus (SLE) or overlap syndrome as the main disease (such as dermatomyositis, fibromyalgia, polymyositis, scleroderma, mixed connective tissue disease, rosacea, sarcoidosis) whose researchers consider will not affect the assessment of the clinical manifestations, activity and efficacy of CLE/SLE diseases and the evaluation of the trial drugs, should discuss with the medical monitor according to the specific circumstances before the screening. c) Excluding secondary Sjögren's syndrome, patients with other autoimmune diseases (such as multiple sclerosis, psoriasis, inflammatory bowel disease, etc.). If the researchers consider it will not affect the assessment of the clinical manifestations, activity and efficacy of CLE/SLE diseases and the evaluation of the trial drugs, should discuss with the medical monitor according to the specific circumstances before the screening. d) Any patients with a significant clinical history of major clinical diseases or clinically significant circulatory system abnormalities, endocrine system abnormalities, digestive system abnormalities, neurological diseases, hematological diseases, immune system diseases, mental disorders and metabolic abnormalities instability; here, "clinically significant" is defined as the researchers consider that participating in the study will pose risks to the safety of the subjects or the disease/disease symptoms during the study period will affect the efficacy or safety analysis. e) NYHA-defined grade III or IV congestive heart failure, or any patient with heart failure symptoms requiring treatment within a recent period classified as NYHA III/IV grade by NYHA. f) Patients with significant electrocardiogram abnormalities during
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change of CLASI-A relative to the baseline at week 16; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the CLASI-A score compared to the baseline values at each visit;The changes in the incidence of adverse events and clinical abnormalities compared with the baseline; | — |
Countries
China
Contacts
Public ContactZhang Zhuoli
Peking University First Hospital
Outcome results
None listed