NonSegmental VitiligoPhase 2NCT04818346

A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo

A Phase 2 study testing INCB054707 in people with NonSegmental Vitiligo, run by Incyte Corporation at 31 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of INCB054707 over a 24-week placebo-controlled double-blind treatment period, followed by a 28-week double-blind extension period in participants with nonsegmental vitiligo. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NonSegmental Vitiligo
What is being tested?: INCB054707
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 171 participants
Where: 31 sitesin 2 countries
Study dates: 6 May 2021to 24 May 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Clinical diagnosis of nonsegmental vitiligo.
History of prior vitiligo treatment with a total duration of at least 3 months.
Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
Willingness to avoid pregnancy or fathering children
Further inclusion criteria apply.

Who cannot join

Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders.
Uncontrolled thyroid function at screening as determined by the investigator.
Women who are pregnant (or who are considering pregnancy) or lactating.
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
Laboratory values outside of the protocol-defined ranges.
Further exclusion criteria apply.

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States23 sites

Investigative Site 002
Brighton, Massachusetts, 02135
Investigative Site 003
Columbus, Ohio, 43215
Investigative Site 024
Covington, Louisiana, 70433
Investigative Site 033
Dallas, Texas, 75230
Investigative Site 015
Gilbert, Arizona, 85295
Investigative Site 010
Hoover, Alabama, 35244
Investigative Site 006
Irvine, California, 92697
Investigative Site 009
Los Angeles, California, 90036
Investigative Site 018
Los Angeles, California, 90045
Investigative Site 004
Murfreesboro, Tennessee, 37130
Investigative Site 007
Norman, Oklahoma, 73071
Investigative Site 032
Orange Park, Florida, 32073
Investigative Site 021
Plymouth Meeting, Pennsylvania, 19462
Investigative Site 001
Portland, Oregon, 97223
Investigative Site 017
Sacramento, California, 95815
Investigative Site 023
Saint Paul, Minnesota, 55112
Investigative Site 012
San Antonio, Texas, 78213
Investigative Site 028
Scottsdale, Arizona, 85260
Investigative Site 030
Spokane, Washington, 99202
Investigative Site 005
Tampa, Florida, 33613
Investigative Site 022
Tampa, Florida, 33614
Investigative Site 027
Verona, New Jersey, 07044
Investigative Site 011
West Palm Beach, Florida, 33401

Other trials in United States

Canada8 sites

Investigative Site 014
Etobicoke, Ontario, M8X 1Y9
Investigative Site 034
London, Ontario, N6H 5LR
Investigative Site 025
Mississauga, Ontario, L5H 1G9
Investigative Site 026
North YORK, Ontario, M2M4J5
Investigative Site 031
Oakville, Ontario, L6J 7W5
Investigative Site 008
Peterborough, Ontario, K9J 5K2
Investigative Site 029
Québec, Quebec, Q1V 4X7
Investigative Site 020
Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 Followed by an Extension Period in Participants With Vitiligo

Conditions: NonSegmental Vitiligo
Being tested: INCB054707, Placebo

What participants receive

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

INCB054707Drug
Also called Povorcitinib
INCB054707 will be administered once daily
PlaceboDrug
Placebo or INCB054707 will be administered once daily

Study groups in NCT04818346
Study group	Role	What they receive
INCB054707 Dose A followed by Dose C	Experimental	Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2). Receives: Drug: INCB054707
INCB054707 Dose B	Experimental	Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2). Receives: Drug: INCB054707
INCB054707 Dose C	Experimental	Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2). Receives: Drug: INCB054707
Placebo followed by INCB054707 Dose C	Placebo comparator	Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2). Receives: Drug: Placebo

What is being measured

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

Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Measured: Baseline; Week 24

Secondary outcomes (3)

Percentage of Participants Achieving T-VASI50 at Week 24
T-VASI50 was defined as a 50% or greater reduction from Baseline in T-VASI. The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites.
Measured: Baseline; Week 24
Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.
Measured: up to Week 24
Extension Period: Number of Participants With Any TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.
Measured: from Week 25 up to Week 76

Timeline

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

6 May 202124 May 2023

First posted26 Mar 2021
Study start6 May 2021
Primary completion24 May 2022
Study completion24 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for NonSegmental VitiligoStudies of the same condition, open and under way.
More trials run by Incyte CorporationThe 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04818346
Sponsor's protocol ID: INCB 54707-205
Status last verified: Mar 2024
First submitted: 25 Mar 2021
Last updated: 11 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Publications

DePietro M, Santos LL, Xue Z, Brown K, Brant JA. Prevalence and Clinical Characteristics of Vitiligo-Associated Hearing Loss Among Patients in a Phase 2 Clinical Trial of Povorcitinib. Dermatol Ther (Heidelb). 2026 Aug 8. doi: 10.1007/s13555-026-01789-9. Online ahead of print.
PubMed 42570211
Passeron T, Pandya AG, Ezzedine K, van Geel N, Erskine L, Santos LL, Xue Z, Blauvelt A. Post Hoc Subgroup and Body Region Analyses of VASI Outcomes Among Patients with Vitiligo in a Phase 2 Povorcitinib Trial. Adv Ther. 2026 Jul 13. doi: 10.1007/s12325-026-03673-6. Online ahead of print.
PubMed 42440041
Pandya AG, Ezzedine K, Passeron T, van Geel N, Brown K, Santos LL, Erskine L, Wagya K, Blauvelt A. Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib in patients with extensive vitiligo in a phase 2, randomized, double-blinded, dose-ranging, placebo-controlled study. J Am Acad Dermatol. 2025 Oct;93(4):946-955. doi: 10.1016/j.jaad.2025.06.027. Epub 2025 Jun 13.
PubMed 40518122

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Non-segmental Vitiligo
Active, not recruitingPhase 3
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Stable Nonsegmental Vitiligo, Active Nonsegmental Vitiligo
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
NonSegmental Vitiligo

All NonSegmental Vitiligo trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 Followed by an Extension Period in Participants With Vitiligo
ClinicalTrials.gov ID: NCT04818346
Acronym / sponsor ID: INCB 54707-205
Conditions: NonSegmental Vitiligo
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 171 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 6 May 2021 (actual)
Primary completion: 24 May 2022 (actual)
Study completion: 24 May 2023 (actual)
First posted: 26 Mar 2021 (actual)
Results: Posted 5 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
INCB054707 Dose A followed by Dose C	Experimental	Drug: INCB054707Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).
INCB054707 Dose B	Experimental	Drug: INCB054707Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2).
INCB054707 Dose C	Experimental	Drug: INCB054707Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).
Placebo followed by INCB054707 Dose C	Placebo comparator	Drug: PlaceboParticipants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Clinical diagnosis of nonsegmental vitiligo.
History of prior vitiligo treatment with a total duration of at least 3 months.
Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
Willingness to avoid pregnancy or fathering children
Further inclusion criteria apply.

Key exclusion criteria (8 listed)

Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders.
Uncontrolled thyroid function at screening as determined by the investigator.
Women who are pregnant (or who are considering pregnancy) or lactating.
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.

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
INCB054707Also: PovorcitinibINCB054707 will be administered once daily	Drug	INCB054707 Dose A followed by Dose C, INCB054707 Dose B, INCB054707 Dose C
PlaceboPlacebo or INCB054707 will be administered once daily	Drug	Placebo followed by INCB054707 Dose C

Primary outcome

Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
Time frame: Baseline; Week 24
The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as ([post-Baseline value minus the Baseline value] / Baseline value) x 100.

3 secondary outcomes

Percentage of Participants Achieving T-VASI50 at Week 24
Time frame: Baseline; Week 24
Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to Week 24
Extension Period: Number of Participants With Any TEAE
Time frame: from Week 25 up to Week 76

Results and safety

Results posted to the registry on 5 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	43	35
Povorcitinib 15 mg	43	38
Povorcitinib 45 mg	43	32
Povorcitinib 75 mg	42	34

Primary outcome: Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24

Time frame: Baseline; Week 24. Geometric least squares mean (Standard Error). Unit: percent change

Measure	Placebo n = 33	Povorcitinib 15 mg n = 38	Povorcitinib 45 mg n = 33	Povorcitinib 75 mg n = 36
Value	2.29 (4.81)	-19.12 (4.56)	-17.78 (4.87)	-15.73 (4.74)

Placebo vs Povorcitinib 15 mg: Least squares mean difference: -21.41 (95% CI -34.49 to -8.32), p = 0.0015, Mixed Model Repeated Measures (MMRM)
Placebo vs Povorcitinib 45 mg: Least squares mean difference: -20.07 (95% CI -33.63 to -6.51), p = 0.0040, MMRM
Placebo vs Povorcitinib 75 mg: Least squares mean difference: -18.02 (95% CI -31.40 to -4.64), p = 0.0086, MMRM

Population analysed: Intent-to-Treat Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Mixed-effect model for repeated measures (MMRM) model: (percent change from Baseline = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\] + visit + treatment\*visit + Baseline measurement + Baseline measurement\*visit). Only participants with available data were analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to Week 76. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 42 (2.4%)	19 of 42 (45.2%)	0 of 42
Povorcitinib 15 mg	0 of 43 (0%)	22 of 43 (51.2%)	0 of 43
Povorcitinib 45 mg	1 of 41 (2.4%)	24 of 41 (58.5%)	0 of 41
Povorcitinib 75 mg	1 of 114 (0.9%)	69 of 114 (60.5%)	0 of 114

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42570211DePietro M, Santos LL, Xue Z, Brown K, Brant JA. Prevalence and Clinical Characteristics of Vitiligo-Associated Hearing Loss Among Patients in a Phase 2 Clinical Trial of Povorcitinib. Dermatol Ther (Heidelb). 2026 Aug 8. doi: 10.1007/s13555-026-01789-9. Online ahead of print.
Derived from this study: PubMed 42440041Passeron T, Pandya AG, Ezzedine K, van Geel N, Erskine L, Santos LL, Xue Z, Blauvelt A. Post Hoc Subgroup and Body Region Analyses of VASI Outcomes Among Patients with Vitiligo in a Phase 2 Povorcitinib Trial. Adv Ther. 2026 Jul 13. doi: 10.1007/s12325-026-03673-6. Online ahead of print.
Derived from this study: PubMed 40518122Pandya AG, Ezzedine K, Passeron T, van Geel N, Brown K, Santos LL, Erskine L, Wagya K, Blauvelt A. Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib in patients with extensive vitiligo in a phase 2, randomized, double-blinded, dose-ranging, placebo-controlled study. J Am Acad Dermatol. 2025 Oct;93(4):946-955. doi: 10.1016/j.jaad.2025.06.027. Epub 2025 Jun 13.
Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Related trials for NonSegmental Vitiligo

Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
Enrolling by invitation
Topical Ruxolitinib Versus Tacrolimus With Excimer Laser for Localized Vitiligo
Vitiligo, Nonsegmental Vitiligo
RecruitingPhase 2
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Non-segmental Vitiligo
Active, not recruitingPhase 3
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Stable Nonsegmental Vitiligo, Active Nonsegmental Vitiligo
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
NonSegmental Vitiligo

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INCB054707 in people with NonSegmental Vitiligo, run by Incyte Corporation at 31 sites in 2 countries.

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 5 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: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 5 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 (time frame: Baseline; Week 24). 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 NCT04818346, which also lists 3 linked publications.

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 11 Apr 2024.