Non Segmental VitiligoPhase 2/3NCT07047612
ICP-332 in Subjects With Non-segmental Vitiligo
A Phase 2/3 study testing ICP-332 Tablets in people with Non Segmental Vitiligo, run by Beijing InnoCare Pharma Tech Co., Ltd. at 45 sites in China.
Trial summary
This a phase II/III randomized, double-blind, placebo-controlled, parallel group, adaptive design, multi-center study to evaluate the efficacy and safety of ICP-332 in subjects with non-segmental vitiligo。The study consisted an phase 2 part and an phase 3 part. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Non Segmental Vitiligo
- 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
- 603 participants
- Where
- 45 sitesChina
- Study dates
- 9 May 2025to Apr 2029
- Phase
- Phase 2/3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18 years and ≤75 years (Phase II portion). Male or female subjects ≥12 years of age and ≤75 years of age, adolescent subjects must weigh ≥40 kg (Phase III portion).
- Eligible subjects must meet all of the following criteria at screening and baseline:
- The clinical diagnosis was non-segmental vitiligo for at least 3 months.
- Involvement of BSA≥5%.
- Facial involvement BSA≥0.5%.
- F-VASI≥0.5 and T-VASI between 5 and 50.
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- Active or stable non-segmental vitiligo was present at both screening and baseline visits.
- Women of childbearing potential (WOCBP) and Men must agree to contraception.
- Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent.
Who cannot join
- Any of the following vitiligo related medical conditions and other skin diseases/conditions.
- Subjects had other types of vitiligo (including but not limited to segmental vitiligo and mixed vitiligo) that did not meet the criteria for active or stable vitiligo described in Inclusion criteria 2.
- History of any clinically major diseases, with the exception of vitiligo.
- Pregnant or breastfeeding females.
- The investigator considers that the subject is not suitable for participation in this study for any reason.
Trial locations and contacts
45 sites in 1 country. Contact the study team or a site near you to ask about taking part.
45 sites in 1 country
China45 sites, 45 recruiting
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Chunlei Zhang
- Not yet recruiting
Beijing Chao-yang Hospital,Capital Medical University
Beijing, Beijing Municipality
Fang Liu
- Not yet recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality
Aihua Wei
- Not yet recruiting
The first hospital of Jilin Univercity
Changchun, Jilin, 130021
Shanshan Li
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Juan Li
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Yunsheng Liang
- Not yet recruiting
Chengdu Second People's Hospital
Chengdu, Sichuan, 610021
Yanping Feng
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Lixia Zhang
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Bin Wei
- Recruiting
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400021
Qingchun 400000 Diao
- Not yet recruiting
Union Hospital affiliated to Fujian Medical
Fuzhou, Fujian, 350001
Huichun Su
- Not yet recruiting
The First Affiliated Hospital of Fujian Medical
Fuzhou, Fujian, 350005
Niu Xiang
- Not yet recruiting
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510120
Liangchun Wang
- Not yet recruiting
Deramatology Hospital of Southern Medical Univercity
Guangzhou, Guangdong, 516006
Xiaowei Shi
- Not yet recruiting
Nanfang Hospital
Guangzhou, Guangdong
Yue Zheng
- Recruiting
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009
Aie Xu
- Not yet recruiting
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang
Liming Wu
- Not yet recruiting
The First Affiliated Hospital of University Of South China
Hengyang, Hunan
Zhijun Liu
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yin Li
- Not yet recruiting
Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital)
Jinan, Shandong, 250022
Furen Zhang
- Not yet recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Yi Sun
- Not yet recruiting
The First Affiliated Hospital Of Kunming Medical University
Kunming, Yunnan, 650032
Dongjie Sun
- Not yet recruiting
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222061
Hong Ren
- Not yet recruiting
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Bin Zhang
- Not yet recruiting
Dermatology hospital of jiangxi province
Nanchang, Jiangxi, 330000
Xiaoyi Wen
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xianwei Cao
- Not yet recruiting
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, 210042
Qianjin Lu
- Not yet recruiting
Nanyang First People's Hospital
Nanyang, Henan, 473000
Rixin Chen
- Not yet recruiting
The First Affiliated Hospital Of Ningbo University
Ningbo, Zhejiang, 315100
Bingjiang Lin
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Folra Xiang
- Not yet recruiting
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200050
Yangfeng Ding
- Not yet recruiting
Shenyang Medical College Affiliated Central Hospital
Shenyang, Liaoning
Xiaodong Li
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
Yanling Li
- Not yet recruiting
Shiyan People's Hospital
Shiyan, Hubei
Zudong Meng
- Not yet recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002
Jun Gu
- Not yet recruiting
The First Affiliated Hospital of Xinxiang Medical College
Weihui, Henan, 453100
Dandan Fu
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Zhiming Li
- Not yet recruiting
Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine)
Wuhan, Hubei, 430022
Liuqing Chen
- Not yet recruiting
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001
Chao Ci
- Not yet recruiting
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
Ruzhi Zhang
- Not yet recruiting
Shaanxi Provincial People's Hospital
Xian, Shanxi, 710068
Li Yang
- Not yet recruiting
The Fourth Affiliated Hospital, Zhejiang University School Of Medicine
Yiwu, Zhejiang, 322000
Lunfei Liu
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Jianguo Li
- Not yet recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan
Zixue Chen
- Not yet recruiting
Zibo Central Hospital
Zibo, Shandong
Guowei Zhao
About this study
Official title: A Phase II/III Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive Design, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Subjects With Non-segmental Vitiligo
This a phase II/III randomized, double-blind, placebo-controlled, parallel group, adaptive design, multi-center study to evaluate the efficacy and safety of ICP-332 in subjects with non-segmental vitiligo。The study consisted an phase 2 part and an phase 3 part.
- Conditions
- Non Segmental Vitiligo
- Being tested
- ICP-332 Tablets, ICP-332 Placebo Tablets
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 dose A（Phase2） | Experimental | Not described Receives: Drug: ICP-332 Tablets |
| Placebo（Phase2） | Placebo comparator | Not described Receives: Drug: ICP-332 Placebo Tablets |
| ICP-332 dose B（Phase2:） | Experimental | Not described Receives: Drug: ICP-332 Tablets |
| ICP-332 dose A or dose B（Phase3） | Experimental | Not described Receives: Drug: ICP-332 Tablets |
| Placebo（Phase3） | 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.
Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24.
Measured: 24 weeks
Phase3: Proportion of subjects achieving F-VASI 75 at Week 52.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start9 May 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Segmental VitiligoStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 603 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
- NCT07047612
- Sponsor's protocol ID
- ICP-CL-00607
- Status last verified
- Apr 2025
- First submitted
- 23 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive Design, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Subjects With Non-segmental Vitiligo
- ClinicalTrials.gov ID
- NCT07047612
- Acronym / sponsor ID
- ICP-CL-00607
- Conditions
- Non Segmental Vitiligo
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 603 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 May 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 2 Jul 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.
This a phase II/III randomized, double-blind, placebo-controlled, parallel group, adaptive design, multi-center study to evaluate the efficacy and safety of ICP-332 in subjects with non-segmental vitiligo。The study consisted an phase 2 part and an phase 3 part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ICP-332 dose A（Phase2） | Experimental | Drug: ICP-332 Tablets |
| Placebo（Phase2） | Placebo comparator | Drug: ICP-332 Placebo Tablets |
| ICP-332 dose B（Phase2:） | Experimental | Drug: ICP-332 Tablets |
| ICP-332 dose A or dose B（Phase3） | Experimental | Drug: ICP-332 Tablets |
| Placebo（Phase3） | Placebo comparator | Drug: ICP-332 Placebo Tablets |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects aged ≥18 years and ≤75 years (Phase II portion). Male or female subjects ≥12 years of age and ≤75 years of age, adolescent subjects must weigh ≥40 kg (Phase III portion).
- Eligible subjects must meet all of the following criteria at screening and baseline:
- Women of childbearing potential (WOCBP) and Men must agree to contraception.
- Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent.
Key exclusion criteria (5 listed)
- Any of the following vitiligo related medical conditions and other skin diseases/conditions.
- History of any clinically major diseases, with the exception of vitiligo.
- Pregnant or breastfeeding females.
- The investigator considers that the subject is not suitable for participation in this study for any reason.
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 dose A or dose B（Phase3）, ICP-332 dose A（Phase2）, ICP-332 dose B（Phase2:） |
| ICP-332 Placebo TabletsICP-332 Placebo will be administered as tablet | Drug | Placebo（Phase2）, Placebo（Phase3） |
Primary outcome
Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24.
Time frame: 24 weeks
Phase3: Proportion of subjects achieving F-VASI 75 at Week 52.
Time frame: 52 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 7 Aug 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.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ICP-332 Tablets in people with Non Segmental Vitiligo, run by Beijing InnoCare Pharma Tech Co., Ltd. at 45 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 9 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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 combined 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.
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 Flora Xiang, Doctor (021-52887775, flora_xiang@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24. (time frame: 24 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 7 Aug 2025.