Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
Recruiting · NCT07440537 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
ICP-488 PlaceboICP-488 Tablets
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- May have concomitant systemic lupus erythematosus (SLE) or not.
- The treatment regimen is stable and can be maintained until the end of the study treatment.
- 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.
- 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
- 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.
- \. 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.
- \. 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).
- Evidence of active, latent, or inadequately treated mycobacterium tuberculosis (TB) infection.
- Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol.
- \. Inadequate organ function levels, including abnormalities in hematology, liver function, renal function, coagulation function, cardiac function, etc.
Where it is running
27 locations listed.
- The First Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
- Peking University First Hospital - Beijing, Beijing Municipality, China
- Xuanwu Hospital Capital Medical University - Beijing, Beijing Municipality, China
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, Chongqing Municipality, China
- Chongqing Hospital of Traditional Chinese Medicine - Chongqing, Chongqing Municipality, China
- The First Affiliated Hospital of Fujian Medical University - Fuzhou, Fujian, China
- Dongguan people's hospital - Dongguan, Guangdong, China
- Dermatology Hospital of Southern Medical University - Guangzhou, Guangdong, China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China
- The Second Hospital of Hebei Medical University - Shijiazhuang, Hebei, China
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
- Jingzhou Central Hospital - Jingzhou, Hubei, China
- Affiliated Drum Tower Hospital, Medical School of Nanjing University - Nanjing, Jiangsu, China
- Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College - Nanjing, Jiangsu, China
- The Second Affiliated Hospital of Soochow University - Suzhou, Jiangsu, China
- Dermatology Hospital of Jiangxi Province - Nanchang, Jiangxi, China
- The First AffiliatedHospital of China Medical University - Shenyang, Liaoning, China
- Jinan Central Hospital - Jinan, Shandong, China
- Dermatology Hospital of Shandong First Medical University - Jinan, Shandong, China
- Huashan Hospital Fudan University - Shanghai, Shanghai Municipality, China
- Shanghai Skin Disease Hospital - Shanghai, Shanghai Municipality, China
- First Hospital of Shanxi Medical University - Taiyuan, Shanxi, China
- West China Hospital, Sichuan University - Chengdu, Sichuan, China
- Sichuan Provincial People's Hospital - Chengdu, Sichuan, China
- People's Hospital of Xinjiang Uygur Autonomous Region - Ürümqi, Xinjiang Uygur Autonomous Region, China
- The First Affiliated Hospital of Kunming Medical University - Kunming, Yunnan, China
- Hangzhou Third people's Hospital - Hangzhou, Zhejiang, China