VitiligoPhase 2NCT04896385

A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)

A Phase 2 study testing Ruxolitinib cream in people with Vitiligo, run by Incyte Corporation at 13 sites in 3 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 the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vitiligo
What is being tested?: Ruxolitinib cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 13 sitesin 3 countries
Study dates: 23 Jun 2021to 10 Jul 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Who cannot join

No pigmented hair within any of the vitiligo areas on the face.
Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
Conditions at baseline that would interfere with evaluation of vitiligo.
Use of any protocol-defined treatments within the indicated washout period before baseline.

Trial locations and contacts

13 sites in 3 countries.

Country

City, postcode or hospital

13 sites in 3 countries

United States6 sites

Suny Downstate Medical Center
Brooklyn, New York, 11203
First Oc Dermatology
Fountain Valley, California, 92708
UC Irvine
Irvine, California, 92697
Mount Sinai Hospital
New York, New York, 10029
Dermatology Specialists of Spokane
Spokane, Washington, 99202
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037

Other trials in United States

Canada4 sites

Simcoderm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Dermatology Research Institute
Calgary, Alberta, T1Y 0B4
Lynderm Research Inc
Markham, Ontario, L3P 1X2
JRB Research Inc
Ottawa, Ontario, K1H 7X8

Other trials in Canada

France3 sites

Hopital Saint Andre
Bordeaux, 33000
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010
Hopital Archet 2 Derm Dept
Nice, 06200

Other trials in France

About this study

Official title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo

The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.

Conditions: Vitiligo
Being tested: Ruxolitinib cream, Vehicle Cream
Keywords: Vitiligo, depigmenting disorder, topical JAK inhibitor
Medical subject headings: Vitiligo

What participants receive

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

Ruxolitinib creamDrug
Also called INCB018424 cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle CreamDrug
Also called Placebo
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Study groups in NCT04896385
Study group	Role	What they receive
Ruxolitinib cream	Experimental	Ruxolitinib cream will be administered twice a day (BID) for 24 weeks Receives: Drug: Ruxolitinib cream
Vehicle Cream	Placebo comparator	Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream. Receives: Drug: Vehicle Cream

What is being measured

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

Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24
Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value)*100.
Measured: Baseline; Week 4, Week 12, and Week 24

Secondary outcomes (5)

Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts
Clinical scores (facial Vitiligo Area Scoring Index [F-VASI] and total body Vitiligo Area Scoring Index [T-VASI]) were evaluated for correlation with skin CXCL10 levels.
Measured: Baseline, Week 12, and Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Measured: from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
Number of Participants With TEAEs During the Treatment-Extension Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Measured: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days
Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. AE severity was assessed per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.
Measured: from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. AE severity was assessed per the CTCAE, version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.
Measured: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days

Timeline

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

23 Jun 202110 Jul 2023

First posted21 May 2021
Study start23 Jun 2021
Primary completion17 Nov 2022
Study completion10 Jul 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 (1)Papers the sponsor has linked to this study.
Other trials for 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: Crossover
Model description: Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04896385
Sponsor's protocol ID: INCB 18424-214
Other IDs: 2021-000361-32
Status last verified: Aug 2025
First submitted: 30 Apr 2021
Last updated: 5 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

Passeron T, Lebwohl M, Lynde C, Alam MS, Laquer VT, Beecker J, Ganesan AK, Timmers C, Volkova A, Soltanalizadeh B, Kornacki D, Smith SH. Vitiligo Biomarker CXCL10 Correlates With Clinical Response to Ruxolitinib Cream in the Phase 2 Randomized TRuE-V Mechanism-of-Action Study. J Invest Dermatol. 2026 Oct 13:S0022-202X(26)03773-5. doi: 10.1016/j.jid.2026.09.857. Online ahead of print.
PubMed 42869214

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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A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo

All Vitiligo trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo
ClinicalTrials.gov ID: NCT04896385
Acronym / sponsor ID: INCB 18424-214
Conditions: Vitiligo
Keywords: Vitiligo, depigmenting disorder, topical JAK inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 23 Jun 2021 (actual)
Primary completion: 17 Nov 2022 (actual)
Study completion: 10 Jul 2023 (actual)
First posted: 21 May 2021 (actual)
Results: Posted 7 Dec 2023

Clinical summary

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

The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.

Arm	Type	Receives
Ruxolitinib cream	Experimental	Drug: Ruxolitinib creamRuxolitinib cream will be administered twice a day (BID) for 24 weeks
Vehicle Cream	Placebo comparator	Drug: Vehicle CreamVehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Who may qualify

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

Key inclusion criteria (3 listed)

A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Key exclusion criteria (6 listed)

No pigmented hair within any of the vitiligo areas on the face.
Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
Conditions at baseline that would interfere with evaluation of vitiligo.

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
Ruxolitinib creamAlso: INCB018424 creamRuxolitinib cream is a topical formulation applied as a thin film to affected areas.	Drug	Ruxolitinib cream
Vehicle CreamAlso: PlaceboVehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.	Drug	Vehicle Cream

Primary outcome

Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24
Time frame: Baseline; Week 4, Week 12, and Week 24
Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value)*100.

5 secondary outcomes

Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts
Time frame: Baseline, Week 12, and Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period
Time frame: from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
Number of Participants With TEAEs During the Treatment-Extension Period
Time frame: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days
Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period
Time frame: from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period
Time frame: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days

Results and safety

Results posted to the registry on 7 Dec 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
Double-Blind Period: Ruxolitinib Cream 1.5% BID	41	37
Double-Blind Period: Vehicle Cream BID	19	14
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID	0	0
Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID	0	0

Primary outcome: Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24

Time frame: Baseline; Week 4, Week 12, and Week 24. Mean (Standard Deviation). Unit: percent change

Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n = 39	Double-Blind Period: Vehicle Cream BID n = 16	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID n = 0	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID n = 0
Week 4	-20.93 (36.216)	8.13 (52.491)	–	–
Week 12	-18.33 (40.035)	21.13 (70.690)	–	–
Week 24	-12.92 (46.146)	22.17 (68.893)	–	–

Population analysed: Safety Population: all participants who applied at least 1 dose of study drug. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Only participants with available data were analyzed.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ruxolitinib Cream 1.5% BID	1 of 55 (1.8%)	10 of 55 (18.2%)	0 of 55
Vehicle Cream BID	0 of 19 (0%)	7 of 19 (36.8%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42869214Passeron T, Lebwohl M, Lynde C, Alam MS, Laquer VT, Beecker J, Ganesan AK, Timmers C, Volkova A, Soltanalizadeh B, Kornacki D, Smith SH. Vitiligo Biomarker CXCL10 Correlates With Clinical Response to Ruxolitinib Cream in the Phase 2 Randomized TRuE-V Mechanism-of-Action Study. J Invest Dermatol. 2026 Oct 13:S0022-202X(26)03773-5. doi: 10.1016/j.jid.2026.09.857. Online ahead of print.
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 Vitiligo

RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults 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.

13 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib cream in people with Vitiligo, run by Incyte Corporation at 13 sites in 3 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 3 inclusion and 6 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 5 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 13 sites in United States, Canada, France. 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 7 Dec 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?

Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24 (time frame: Baseline; Week 4, Week 12, and 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 NCT04896385, which also lists 1 linked publication.

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 5 Aug 2025.