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New pill could tame skin lupus flares

NCT ID NCT07440537

Disease control Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an oral medication called ICP-488 for people with cutaneous lupus erythematosus (CLE), a condition that causes painful skin rashes and lesions. About 105 adults aged 18–75 with moderate-to-severe CLE will receive either the drug or a placebo for 16 weeks. The main goal is to see if the drug reduces skin disease severity and is safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous lupus erythematosus discoid lupus erythematosus subacute cutaneous lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous lupus erythematosus (CLE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Chongqing Hospital of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, 400021, China

  • Dermatology Hospital of Jiangxi Province

    RECRUITING

    Nanchang, Jiangxi, 330000, China

  • Dermatology Hospital of Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250022, China

  • Dermatology Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510091, China

  • Dongguan people's hospital

    RECRUITING

    Dongguan, Guangdong, 523059, China

  • First Hospital of Shanxi Medical University

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030001, China

  • Hangzhou Third people's Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, Qianjin Lu, China

  • Huashan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, Shandong, 250013, China

  • Jingzhou Central Hospital

    NOT_YET_RECRUITING

    Jingzhou, Hubei, 434020, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    NOT_YET_RECRUITING

    Ürümqi, Xinjiang Uygur Autonomous Region, 830001, China

  • Shanghai Skin Disease Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200443, China

  • Sichuan Provincial People's Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610072, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of Anhui Medical University

    NOT_YET_RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Chongqing Medical University

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, 400010, China

  • The First Affiliated Hospital of Fujian Medical University

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, 650032, China

  • The First Affiliated Hospital of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First AffiliatedHospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110001, China

  • The Second Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215004, China

  • The Second Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • West China Hospital, Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • Xuanwu Hospital Capital Medical University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100053, China

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