NCT07440537 Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
| NCT ID | NCT07440537 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
| Condition | Cutaneous Lupus Erythematosus (CLE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 105 participants in total. It began in 2026-04-27 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07440537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cutaneous Lupus Erythematosus (CLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07440537 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07440537 currently recruiting?
Yes, NCT07440537 is actively recruiting participants. Contact the research team at CO_HGRAC@innocarepharma.com for enrollment information.
Where is the NCT07440537 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Chongqing, China and 11 additional locations.
Who is sponsoring the NCT07440537 clinical trial?
NCT07440537 is sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. The trial plans to enroll 105 participants.
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