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Tests treatment safety and results for Cutaneous Lupus Erythematosus (CLE)
Official title Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
ClinicalTrials.gov ID: NCT07440537
What this study is testing
What is ICP-488 Tablets?
ICP-488 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cutaneous lupus erythematosus (cle).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- Specific cutaneous lupus erythematosus subtypes: acute cutaneous lupus erythematosus (ACLE), tumid lupus, lupus panniculitis (deep lupus), chilblain...
- Patients with drug-induced cutaneous lupus erythematosus and/or drug-induced systemic lupus erythematosus.
- people with active kidney disease 4．Other inflammatory joint or skin diseases or overlap syndrome not caused by systemic lupus erythematosus (SLE) as...
See the full eligibility 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 people must agree to use highly effective contraceptive methods throughout the study treatment period and for one month (28 days) after the last dose
- 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.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Zhengzhou, Henan, China
- Jingzhou, Hubei, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Chengdu, Sichuan, China
- Ürümqi, Xinjiang Uygur Autonomous Region, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Dongguan, Guangdong, China; Guangzhou, Guangdong, China and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.