Atopic DermatitisPhase 3NCT06775860
ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
A Phase 3 study testing ICP-332 Tablets in people with Atopic Dermatitis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 62 sites in China.
Trial summary
A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ICP-332 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 552 participants
- Where
- 62 sitesChina
- Study dates
- 14 Nov 2024to 25 Dec 2026
- Phase
- Phase 3
- 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
- Male or female subjects between 18 and 75 years of age.
- Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
- Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
- Subjects must meet the following criteria for disease activity:
- Eczema Area and Severity Index (EASI) score ≥ 16 ;
- (Body Surface Area )BSA affected by AD ≥ 10% ;
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- (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;
- Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
- Women of childbearing potential (WOCBP) and Men must agree
- 5. Women of childbearing potential (WOCBP) and Men must agree to contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- Pregnant or breastfeeding females.
- History of any clinically major diseases, with the exception of atopic dermatitis.
- Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.
Trial locations and contacts
62 sites in 1 country. Contact the study team or a site near you to ask about taking part.
62 sites in 1 country
China62 sites, 62 recruiting
- Recruiting
Capital Medical University Affiliated Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Fang Liu
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Hang Li
- Recruiting
Capital Medical University Affiliated Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Linfeng Li
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Chunlei Zhang
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Aihua Wei
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Yi Zhao
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Shanshan Li
- Recruiting
Central South University Xiangya Hospital
Changsha, Hunan, 410008
Juan Su
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Rong Xiao
- Recruiting
Changzhou First People's Hospital
Changzhou, Jiangsu, 213003
Yanxia Yuan
- Recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000
Xinsuo Duan
- Recruiting
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017
Yanyan Feng
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Lixia Zhang
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Aijun Chen
- Recruiting
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400021
Qingchun Diao
- Recruiting
The Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001
Huichun Su
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Chao Ji
- Recruiting
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000
Jingfa Lu
- Recruiting
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Yunsheng Liang
- Recruiting
Zhongshan University Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Liangchun Wang
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Yue Zheng
- Recruiting
Affiliated Hospital of Hebei University of Engineering
Handan, Hebei, 056002
Guoying Miao
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Liming Wu
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Xiaoyong Man
- Recruiting
The Third People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310009
Aie Xu
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Zaixing Wang
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050
Xinxiang Lv
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Ying Li
- Recruiting
Shandong Provincial Dermatosis Hospital
Jinan, Shandong, 250022
Furen Zhang
- Recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Yi Sun
- Recruiting
Jining First People's Hospital
Jining, Shandong, 272011
Dongmei Shi
- Recruiting
Affiliated Hospital of Jiujiang University
Jiujiang, Jiangxi, 332000
Qiuhe Song
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Weijia Zhao
- Recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Min Xiao
- Recruiting
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Lin Chen
- Recruiting
Jiangxi Provincial Dermatology Hospital
Nanchang, Jiangxi, 330001
Guohong Hu
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xianwei Cao
- Recruiting
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu, 211166
Bin Chen
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Bingjiang Lin
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Guanzhi Chen
- Recruiting
Sanmenxia Central Hospital
Sanmenxia, Henan, 472000
Danhong Jiao
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Jun Gu
- Recruiting
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
Zhouwei Wu
- Recruiting
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
Yangfeng Ding
- Recruiting
Yuebei People's Hospital
Shaoguan, Guangdong, 512026
Weiquan Li
- Recruiting
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）
Shenyang, Liaoning, 110001
Yan Liu
- Recruiting
Zhongyi Northeast International Hospital Co., Ltd.
Shenyang, Liaoning, 110179
Shifa Zhang
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Wenzhong Wu
- Recruiting
Second Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Yanling Li
- Recruiting
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300052
Huiping Wang
- Recruiting
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300120
Litao Zhang
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Zhiming Li
- Recruiting
Wuhan Central Hospital
Wuhan, Hubei, 430014
Ying Gao
- Recruiting
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
Wuhan, Hubei, 430022
Liuqing Chen
- Recruiting
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000
Ruzhi Zhang
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yan Zheng
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Li Yang
- Recruiting
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, 361021
Mingkai Ji
- Recruiting
Yancheng First People's Hospital
Yancheng, Jiangsu, 224001
Pingping Qin
- Recruiting
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Lunfei Liu
- Recruiting
Yuncheng Central Hospital
Yuncheng, Shanxi, 440000
Juanli Fan
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Jianguo Li
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of Oral ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- ICP-332 Tablets, ICP-332 Placebo Tablets
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-332 TabletsDrug
ICP-332 will be administered as tablet
ICP-332 Placebo TabletsDrug
ICP-332 Placebo will be administered as tablet
| Study group | Role | What they receive |
|---|---|---|
| ICP-332 | Experimental | Not described Receives: Drug: ICP-332 Tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: ICP-332 Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline
Measured: 16 weeks
Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start14 Nov 2024
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 552 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
- NCT06775860
- Sponsor's protocol ID
- ICP-CL-00604
- Status last verified
- Jan 2025
- First submitted
- 25 Dec 2024
- Last updated
- 8 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of Oral ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06775860
- Acronym / sponsor ID
- ICP-CL-00604
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 15 Jan 2025 (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.
A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP-332 | Experimental | Drug: ICP-332 Tablets |
| Placebo | Placebo comparator | Drug: ICP-332 Placebo Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects between 18 and 75 years of age.
- Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
- Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
- Subjects must meet the following criteria for disease activity:
- Women of childbearing potential (WOCBP) and Men must agree
Key exclusion criteria (5 listed)
- Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- Pregnant or breastfeeding females.
- History of any clinically major diseases, with the exception of atopic dermatitis.
- Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.
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-332 TabletsICP-332 will be administered as tablet | Drug | ICP-332 |
| ICP-332 Placebo TabletsICP-332 Placebo will be administered as tablet | Drug | Placebo |
Primary outcome
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline
Time frame: 16 weeks
Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline
Time frame: 16 weeks
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 Sep 2025.
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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.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ICP-332 Tablets in people with Atopic Dermatitis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 62 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 10 inclusion and 5 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Pengcheng Lei (+86 18501252185, pengcheng.lei@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 Sep 2025.