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NonSegmental VitiligoPhase 3NCT07865312

A Phase 3 Study of Povorcitinib Phosphate in Chinese Adults With Nonsegmental Vitiligo

A Phase 3 study testing Povorcitinib phosphate in people with NonSegmental Vitiligo, run by Dermavon Holdings Limited at 44 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This Phase 3 study will evaluate the efficacy and safety of oral povorcitinib phosphate compared with placebo in Chinese adults with nonsegmental vitiligo who are considered suitable for systemic therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NonSegmental Vitiligo
What is being tested?
Povorcitinib phosphate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
174 participants
Where
44 sitesChina
Study dates
Nov 2026to Jun 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to understand and willing to sign written informed consent.
  • Age ≥18 years at consent; any sex.
  • Clinical diagnosis of nonsegmental vitiligo, with all of the following at screening and baseline: T-BSA ≥5%; T-VASI ≥4; F-BSA ≥0.5%; F-VASI ≥0.5%; and Considered suitable for systemic therapy by the investigator.Note: When assessing body surface area (BSA) and the Vitiligo Area Scoring Index (VASI), a Wood's lamp must be used in a darkroom. 4. Agrees to discontinue all vitiligo treatments from screening through the last safety follow-up visit.
  • 5. Agree to adopt effective contraceptive measures and meet the following requirements:
  • Men with fertility potential: use highly effective contraception within at least 90 days from screening to the last dose of medication; do not donate sperm.
  • Women with fertility potential (WOCBP): negative serum pregnancy test at screening, and negative urine pregnancy test prior to the first dose; use highly effective contraception within at least 90 days from screening to the last dose of medication; do not donate oocytes.
  • Women without fertility potential (as defined in Appendix A) are exempt from the above restrictions.
  • 6. Willing and able to comply with study procedures, including standardized lesion photography.

Who cannot join

  • Patients clinically diagnosed with other types of vitiligo (e.g., segmental vitiligo) or other hypopigmentary skin disorders (including but not limited to piebaldism, pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive patchy hypopigmentation, nevus anemicus, chemical leukoderma, and pityriasis versicolor).
  • Following screening evaluation, white hair appears on more than 33% of the facial body surface area affected by vitiligo lesions; or white hair appears on more than 33% of the total body surface area (including the face) affected by vitiligo lesions.
  • Spontaneous and pronounced repigmentation occurring within the 6 months prior to screening (e.g., evident repigmentation without any prior treatment, as determined by the investigator).
  • Current or prior use of decolorizing agents such as hydroquinone monobenzyl ether (including Benoquin® [Monohydroquinone]).
  • History of melanocyte-keratinocyte transplantation or other surgical treatments for vitiligo.
  • The subject had used laser therapy or phototherapy (including tanning beds) within the 8 weeks preceding the first dose.
Show all 52Show fewer
  • The subject had used dihydroxyacetone (commonly found in tanning products) within the 4 weeks preceding the first dose.
  • The subject had poorly controlled thyroid disease as assessed by the investigator and/or a specialist, or exhibited clinically significant abnormalities in thyroid-stimulating hormone (TSH) or free T3 and free T4 during screening, indicating active thyroid dysfunction.
  • The subject was pregnant or breastfeeding, or had plans to become pregnant during the study period.
  • The following concomitant diseases or past medical history are present:
  • current or past history of thrombocytopenia, coagulopathy, or platelet dysfunction; or current use of anticoagulants or medications known to induce thrombocytopenia.
  • History of venous thrombosis or arterial embolism, including but not limited to deep vein thrombosis, pulmonary embolism, moderate to severe heart failure [NYHA class III or IV], cerebrovascular accident within 6 months prior to screening, myocardial infarction, coronary stent implantation, or coronary artery bypass grafting [CABG].
  • Diagnosis of other serious cardiovascular diseases, including but not limited to angina pectoris, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or various forms of myocarditis.
  • Uncontrolled hypertension (as assessed by the investigator).
  • Disabled patients requiring bed rest or wheelchair use.
  • Patients who have undergone organ transplantation.
  • Presence of any malignant tumor or history of malignant tumor (excluding well-treated cases such as basal cell carcinoma or squamous cell carcinoma of the skin).
  • Conditions that may interfere with drug absorption, including but not limited to short bowel syndrome.
  • Chronic or recurrent infectious diseases, including but not limited to chronic renal infections, chronic thoracic infections (e.g., bronchiectasis), recurrent urinary tract infections (recurrent pyelonephritis or chronic persistent cystitis), fungal infections, prior history of prosthetic joint infection, or open, exudative, or infected skin wounds or ulcers. Current or past history of disseminated herpes zoster, or recurrent herpes zoster (with more than one episode).
  • Current or past history of disseminated herpes simplex.
  • Having received systemic anti-infective therapy within 4 weeks prior to the first dose, or having any active infection judged by the investigator to be unsuitable for participation in this study.
  • Albinism.
  • Any other clinically significant disease, other than vitiligo, judged by the investigator to be unsuitable for participation in this clinical study.
  • During screening, the 12-lead electrocardiogram should demonstrate clinically significant abnormalities requiring treatment (e.g., acute myocardial infarction, severe tachyarrhythmias or bradyarrhythmias), or indicate the presence of serious underlying cardiac disease (e.g., cardiomyopathy, severe congenital heart disease, diffuse low voltage in all leads, Wolff-Parkinson-White syndrome), or show a QTc interval>480 ms.
  • The subject must have experienced severe trauma or major surgery within 30 days prior to the screening visit, as judged by the investigator.
  • The subject must also have a history of clinically significant drug or alcohol abuse within the 6 months preceding the screening visit, as judged by the investigator.
  • The subject must have a history of failed treatment with any systemic or topical JAK inhibitor for vitiligo or other inflammatory diseases.
  • The washout period prior to the first dose must meet one of the following criteria:
  • For any investigational or experimental therapy, <12 weeks or 5 half-lives (if known), whichever is longer;
  • For immunomodulatory biologics, <12 weeks or 5 half-lives (if known), whichever is longer;
  • For live vaccines, <8 weeks, or if the subject is scheduled to receive a live vaccine during the study period or within 8 weeks after the last dose of the study drug.
  • Systemic immunosuppressive or immunomodulatory small-molecule agents (e.g., corticosteroids [oral or intravenous], methotrexate, cyclosporine, dapsone, azathioprine, etc.) must have been discontinued for <4 weeks.
  • Note: The use of inhaled or nasal corticosteroids is permitted. Note: For non-cutaneous conditions (e.g., exacerbation of asthma, bronchitis), if judged acceptable by the investigator and the sponsor (or their designated personnel), prednisone-equivalent doses ≤10 mg/day may be used for ≤7 consecutive days.
  • For any topical or systemic JAK inhibitor: <4 weeks.
  • For traditional Chinese medicines/proprietary Chinese medicines used in the treatment of vitiligo: <4 weeks.
  • For any topical treatment of vitiligo other than JAK inhibitors: <2 weeks.
  • For any oral or topical PDE4 inhibitor (e.g., apremilast, criborol): <1 week.
  • For potent systemic CYP3A4 inhibitors and potent systemic CYP3A4 inducers: <1 week or 5 half-lives (if known), whichever is longer. Examples include, but are not limited to: fluconazole, itraconazole, carbamazepine, ritonavir, St. John's wort, grapefruit/grapefruit juice.
  • During screening visits, any of the following abnormal laboratory test results shall be considered:
  • serum aspartate aminotransferase (AST)> 2×ULN;
  • serum alanine aminotransferase (ALT)> 2×ULN;
  • total bilirubin (TBIL) ≥ 1.5×ULN (trial participants with a history of Gilbert syndrome who have TBIL ≥ 1.5×ULN but direct bilirubin (DBIL) ≤ ULN shall not be excluded based on this criterion);
  • absolute neutrophil count (ANC) <1.5×10⁹/L;
  • platelet count (PLT) <90×10⁹/L;
  • hemoglobin (HGB) <90 g/L;
  • other laboratory abnormalities that are clinically significant and judged by the investigators to render the participant unsuitable for enrollment.
  • Note: If a laboratory test result exceeds the threshold specified in the protocol but is suspected to be transient (e.g., due to physiological factors or assay variability), or only marginally exceeds the threshold, the test may be repeated once during the screening period (only once is permitted) to clarify the result. If the repeat test still exceeds the threshold, the trial participant shall be excluded from screening.
  • Evidence of Mycobacterium tuberculosis infection (i.e., tuberculosis) is present.
  • A positive anti-HIV antibody test result is present.
  • Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or risk of HBV or HCV relapse, is present.
  • The participant has a known hypersensitivity to povotuxin phosphate or to any excipient contained in povotuxin phosphate tablets.
  • Any condition-as judged by the investigator-that could compromise the participant's full participation in the study (including administration of the study medication and attendance at scheduled study visits), pose a significant risk to the participant, or interfere with the interpretation of study data, laboratory results, or screening assessment outcomes.

Trial locations and contacts

44 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Le Peng contact

0755-82418801

pengle@cms.net.cn

44 sites in 1 country

China44 sites

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Fang Liu

    Fang Liu

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Fenglin Cui

    Fenglin Cui

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Aihua Wei

    Aihua Wei

  • The First Hospital of Jilin University

    Changchun, Jilin

    Shanshan Li

    Shanshan Li

  • Changde First People's Hospital

    Changde, Hunan

    Jianjian Zhu

    Jianjian Zhu

  • The Affiliated Hospital of Chengde Medical University

    Chengde, Hebei

    Xinsuo Duan

    Baoqiang Li

  • Chengdu Second People's Hospital

    Chengdu, Sichuan

    Yanyan Feng

    Yanyan Feng

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Jin Chen

    Jin Chen

  • Dalian Dermatosis Hospital

    Dalian, Liaoning

    Chengzhi Lü

    Chengzhi Lü

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Zhiqi Song

    Zhiqi Song

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong

    Bin Yang

    Bin Yang

  • Dongguan People's Hospital

    Guangzhou, Guangdong

    Changxing Li

    Changxing Li

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Zhongrong Liu

    Zhongrong Liu

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Jiande Han

    Jiande Han

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Qingfang Xu

    Qingfang Xu

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang

    Aie Xu

    Xingang Wu

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Chunjun Yang

    Chunjun Yang

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

    Wei Qin

    Wei Qin

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Ying Li

    Ying Li

  • Shandong Provincial Institute of Dermatology and Venereology

    Jinan, Shandong

    Furen Zhang

    Furen Zhang

  • Jingzhou Central Hospital

    Jingzhou, Hubei

    Yi Sun

    Yi Sun

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Dongjie Sun

    Dongjie Sun

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Ougen Liu

    Ougen Liu

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Sijian Wen

    Sijian Wen

  • Nanyang First People's Hospital

    Nanyang, Henan

    Hui Ma

    Hui Ma

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

    Bingjiang Lin

    Bingjiang Lin

  • Sanmenxia Central Hospital

    Sanmenxia, Henan

    Xiaojing Zheng

    Xiaojing Zheng

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

    Zhouwei Wu

    Zhouwei Wu

  • Affiliated Central Hospital of Shenyang Medical College

    Shenyang, Liaoning

    Xiaodong Li

    Xiao'dong Li

  • Shenyang Hospital of Traditional Chinese and Western Medicine (Shenyang No. 7 People's Hospital; Shenyang Institute of Dermatology)

    Shenyang, Liaoning

    Mingqiang Sun

    Mingqiang Sun

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

    Jianglin Zhang

    Jianglin Zhang

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong

    Cuihong Lian

    Cuihong Lian

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Guoqiang Zhang

    Guoqiang Zhang

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Yanling Li

    Yanling Li

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu

    Jun Gu

    Jun Gu

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

    Yuying Kang

    Yuying Kang

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Shuping Guo

    Shuping Guo

  • The People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang

    Xiaojing Kang

    Xiaojing Kang

  • Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No. 1 Hospital)

    Wuhan, Hubei

    Liuqing Chen

    Liuqing Chen

  • The First Affiliated Hospital of Air Force Military Medical University

    Xi’an, Shanxi

    Chunying Li, 029-84775401, lichying@fmmu.edu.cn

    Chunying Li

  • Xingtai People's Hospital

    Xingtai, Hebei

    Fang Cheng

    Fang Cheng

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Hongwei Liu

    Hongwei Liu

  • Zhengzhou Central Hospital

    Zhengzhou, Henan

    Zixue Chen

    Zixue Chen

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

    Hui Xu

    Hui Xu

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Povorcitinib Phosphate Tablets in Chinese Adult Participants With Nonsegmental Vitiligo

This Phase 3 study will evaluate the efficacy and safety of oral povorcitinib phosphate compared with placebo in Chinese adults with nonsegmental vitiligo who are considered suitable for systemic therapy. Approximately 174 participants will be randomized 1:1 to povorcitinib phosphate 30 mg once daily or matching placebo for 52 weeks, followed by a 4-week safety follow-up. The primary efficacy assessment is proportion of participants achieving ≥75% improvement from baseline in face vitiligo area scoring index at Week 52.

Being tested
Povorcitinib phosphate, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Povorcitinib phosphateDrug

    Povorcitinib phosphate tablets, 30 mg orally once daily for 52 weeks.

  • PlaceboDrug

    Matching placebo orally once daily for 52 weeks.

Study groups in NCT07865312
Study groupRoleWhat they receive
Povorcitinib phosphateExperimentalNot described
Receives: Drug: Povorcitinib phosphate
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants achieving F-VASI 75 at Week 52

    Proportion of participants achieving ≥75% improvement from baseline in face vitiligo area scoring index (F-VASI 75). F-VASI 75 is defined as at least a 75% improvement from baseline in Facial Vitiligo Area Scoring Index(F-VASI).

    F-VASI is measured by multiplying the vitiligo involvement value assessed on each facial area by the percentage of affected skin, then adding the values from all areas.

    Measured: Week 52

Secondary outcomes (8)

  1. Change from baseline in T-VASI at Week 52

    T-VASI uses a formula that considers all body parts (range: 0-100), as follows: VASI = Σ All body parts [palm units] × [degree of decolorization].

    Measured: Week 52

  2. Proportion of participants achieving T-VASI 50/75/90 at Week 52

    Proportion of participants achieving ≥50%/75%/90% improvement from baseline in total body vitiligo area scoring index（T-VASI 50/75/90）

    Measured: Week 52

  3. Proportion of participants achieving F-VASI 50/90 at Week 52

    Proportion of participants achieving ≥50%/90% improvement from baseline in face vitiligo area scoring index (F-VASI 50/90)

    Measured: Week 52

  4. Proportion of participants with VNS significantly lower (4) or no longer obvious (5) at Week 52

    Vitiligo noticeability scale(VNS) is a patient-reported scale measuring the success of vitiligo treatment, using a 5-point scale. Participants were shown baseline facial photos for reference and provided with mirrors to assess their facial vitiligo.

    Measured: Week 52

  5. F-PaGIC-V

    Facial patient global impression of change-vitiligo (F-PaGIC-V) is an assessment of participants' facial vitiligo improvement. It uses a 7-point scale to compare the facial vitiligo area at the post-treatment visit with the baseline facial vitiligo area. It responds to the overall improvement in facial vitiligo. An F-PaGIC-V score of 1 or 2 can be considered treatment success.

    Measured: Week 52

  6. T-PaGIC-V

    Total body patient global impression of change-vitiligo (T-PaGIC-V) is an assessment of participants' overall vitiligo improvement. It uses a 7-point scale to compare the total vitiligo area at the post-treatment visit with the baseline area. It responds to the overall improvement in vitiligo. A T-PaGIC-V score of 1 or 2 indicates patient response.

    Measured: Week 52

  7. VitiQoL

    Vitiligo-specific quality of life (VitiQoL) is a quality of life assessment with 15 items, requiring participants to rate various aspects of their condition over the past month on a 7-point scale (from "never" to "always has").

    Measured: Week 52

  8. the skin color questionnaire (if needed)

    Distribution of participants in each tier of the skin color questionnaire (if needed)

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionMay 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07865312
Sponsor's protocol ID
Povor-03-001
Status last verified
Oct 2026
First submitted
3 Oct 2026
Last updated
8 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Povorcitinib phosphate in people with NonSegmental Vitiligo, run by Dermavon Holdings Limited at 44 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 52 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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 Le Peng (0755-82418801, pengle@cms.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving F-VASI 75 at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07865312.

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 Oct 2026.

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