Cutaneous Lupus Erythematosus (CLE)Phase 2NCT07440537
Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
A Phase 2 study testing ICP-488 Tablets in people with Cutaneous Lupus Erythematosus (CLE), run by Beijing InnoCare Pharma Tech Co., Ltd. at 27 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cutaneous Lupus Erythematosus (CLE)
- What is being tested?
- ICP-488 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 27 sitesChina
- Study dates
- 27 Apr 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- 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.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
China27 sites, 27 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhuoli Zhang, zhuoli.zhang@126.com
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Yi Zhao, zhaoyi_peking@163.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Xian Jiang, jennyxianj@163.com
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Xuejun Chen, cxjpfk2022@126.com
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Sheng Fang, fangshengderm@163.com
- Not yet recruiting
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, 400021
Qingchun Qiao, qchdiao@vip.sina.com
- Recruiting
Dongguan people's hospital
Dongguan, Guangdong, 523059
Guangming Han, Ghan54321@163.com
- Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Niu Xiang, 408089668@qq.com
- Recruiting
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Yu Wang, yuzirain103@163.com
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Liangchun Wang, wliangch@mail.sysu.edu.cn
- Not yet recruiting
Hangzhou Third people's Hospital
Hangzhou, Zhejiang, 310009
xingang Wu, wuxingang1986@126.com
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
zaixing Wang, wzx2370@163.com
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
Lihua Wang, 15318816237@163.com
- Recruiting
Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, 250022
Furen Zhang, zhangfurenlcsy@163.com
- Not yet recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Yi Sun, jzzxyysy@163.com
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Xiang Nong, nx7011@126.com
- Recruiting
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000
Guohong Hu, 420079850@qq.com
- Not yet recruiting
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008
lingyun Sun, lingyunsun2012@163.com
- Not yet recruiting
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Nanjing, Jiangsu, Qianjin Lu
qianjin Lu, qianlu5860@gmail.com
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Jinhua Xu, xjhhsyy@163.com
- Not yet recruiting
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
Yangfeng Ding, dingyangfeng@aliyun.com
- Not yet recruiting
The First AffiliatedHospital of China Medical University
Shenyang, Liaoning, 110001
Ting Xiao, cmuxt@126.com
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Yanling Li, lyldoctor@sina.com
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Zhichun Liu, Lzchun5190@sina.com
- Not yet recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Shuping Guo
gsp6688@sina.com
- Not yet recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, 830001
Xiaojing Kang, drkangxj666@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
shengyun Liu, fccliusy2@zzu.edu.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE)
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).
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Being tested
- ICP-488 Tablets, ICP-488 Placebo
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-488 TabletsDrug
Patients will receive ICP-488 orally as per the protocol
ICP-488 TabletsDrug
Patients will receive ICP-488 orally as per the protocol
ICP-488 PlaceboOther
Patients will receive ICP-488 Placebo orally as per the protocol.
| Study group | Role | What they receive |
|---|---|---|
| ICP-488 Dose A | Experimental | Not described Receives: Drug: ICP-488 Tablets |
| ICP-488 Dose B | Experimental | Not described Receives: Drug: ICP-488 Tablets |
| ICP-488 Placebo | Placebo comparator | Not described Receives: Other: ICP-488 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16.
Measured: All the subjects completed the 16-week assessment.
Secondary outcomes (9)
At each visit, the proportion of subjects whose CLASI-A score improved by ≥50% compared to the baseline value (CLASI-50).
Measured: From baseline to week 28
The proportion of subjects with disease improvement as defined by a reduction of ≥4 points relative to the baseline value of CLASI-A （CLASI ≥ 4）at each visit.
Measured: From baseline to week 28
The average change of the CLASI-A score from the baseline value at each visit.
Measured: From baseline to week 28
The percentage change of CLASI-A relative to the baseline at each visit.
Measured: From baseline to week 28
Adverse events that occurred during treatment.
Measured: From baseline to week 28
The incidence of clinical abnormalities such as laboratory test results, electrocardiogram (ECG), and vital signs, and the changes relative to the baseline.
Measured: From baseline to week 28
Maximum Concentration at Steady State(Cmax,ss)
Measured: From baseline to week 12
Steady-State Time to Maximum
Measured: From baseline to week 12
Area under the curve (AUC)
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start27 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus Erythematosus (CLE)Studies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440537
- Sponsor's protocol ID
- ICP-CL-01008
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE)
- ClinicalTrials.gov ID
- NCT07440537
- Acronym / sponsor ID
- ICP-CL-01008
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICP-488 Dose A | Experimental | Drug: ICP-488 Tablets |
| ICP-488 Dose B | Experimental | Drug: ICP-488 Tablets |
| ICP-488 Placebo | Placebo comparator | Other: ICP-488 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICP-488 TabletsPatients will receive ICP-488 orally as per the protocol | Drug | ICP-488 Dose A |
| ICP-488 TabletsPatients will receive ICP-488 orally as per the protocol | Drug | ICP-488 Dose B |
| ICP-488 PlaceboPatients will receive ICP-488 Placebo orally as per the protocol. | Other | ICP-488 Placebo |
Primary outcome
The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16.
Time frame: All the subjects completed the 16-week assessment.
9 secondary outcomes
At each visit, the proportion of subjects whose CLASI-A score improved by ≥50% compared to the baseline value (CLASI-50).
Time frame: From baseline to week 28
The proportion of subjects with disease improvement as defined by a reduction of ≥4 points relative to the baseline value of CLASI-A （CLASI ≥ 4）at each visit.
Time frame: From baseline to week 28
The average change of the CLASI-A score from the baseline value at each visit.
Time frame: From baseline to week 28
The percentage change of CLASI-A relative to the baseline at each visit.
Time frame: From baseline to week 28
Adverse events that occurred during treatment.
Time frame: From baseline to week 28
The incidence of clinical abnormalities such as laboratory test results, electrocardiogram (ECG), and vital signs, and the changes relative to the baseline.
Time frame: From baseline to week 28
Maximum Concentration at Steady State(Cmax,ss)
Time frame: From baseline to week 12
Steady-State Time to Maximum
Time frame: From baseline to week 12
Area under the curve (AUC)
Time frame: From baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICP-488 Tablets in people with Cutaneous Lupus Erythematosus (CLE), run by Beijing InnoCare Pharma Tech Co., Ltd. at 27 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexia Lu (010-66609745, CO_HGRAC@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16. (time frame: All the subjects completed the 16-week assessment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.