Trial · NCT03099304

A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

NCT03099304, Phase 2, Completed, Incyte Corporation; results first posted 2021-12-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo. Trials, record NCT03099304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03099304

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
NCT number: NCT03099304
Status: Completed
Phases: Phase 2
Enrollment: 157 participants, actual
Lead sponsor: Incyte Corporation
Conditions: Vitiligo
Interventions: Ruxolitinib cream, Vehicle cream
First posted: 2017-04-04
Last updated: 2022-11-17
Results first posted: 2021-12-10

Source ClinicalTrials.gov

Registered outcomes49

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24	Baseline; Week 24	An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Secondary	Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear	Week 24	The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening.
Secondary	Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52	Baseline; Week 52	T-VASI was measured by the percentage of vitiligo involvement from all body regions (percentage of BSA; assessed by the Investigator) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each body site and summing all values (possible range: 0-100; lower scores indicate increased improvement).
Secondary	Dose Response on Percentage Change From Baseline in F-VASI	up to 156 weeks
Secondary	Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24	up to 24 weeks	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, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention 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 intervention indicated.
Secondary	Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52	up to 52 weeks	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention 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 intervention indicated.
Secondary	Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52	Week 24 to Week 52	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention 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 intervention indicated.
Secondary	Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE	up to Week 156	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention 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 intervention indicated.
Secondary	Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156	Week 52 to Week 156	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention 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 intervention indicated.
Secondary	Mean Change From Baseline in F-VASI Score at Week 24	Baseline; Week 24	F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

1 to 10 of 49Source ClinicalTrials.gov

See all 49 registered outcomes

Outcomes49

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24	Baseline; Week 24	Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were to be defined according to the treatment assignment at the time of randomization regardless of the actual ruxolitinib cream or vehicle cream participants might have applied during their participation in the study. Missing post-Baseline values were considered as not having achieved responses for visits up to Week 52.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear	Week 24	ITT Population. Missing post-Baseline values were considered as not having achieved F-PhGVA response for visits up to Week 24.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52	Baseline; Week 52	ITT Population. Missing post-Baseline values were considered as not having achieved responses for visits up to Week 52. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Dose Response on Percentage Change From Baseline in F-VASI	up to 156 weeks	Based on the data for percentage change from Baseline in F-VASI and T-VASI scores during the treatment periods, the Emax model was not appropriate; therefore, the dose responses were not assessed.
SECONDARY	Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24	up to 24 weeks	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52	up to 52 weeks	Safety Population. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Analysis from Day 1 to Week 52 was conducted in participants randomized to receive ruxolitinib cream 0.5% QD, ruxolitinib cream 1.5% QD, or ruxolitinib cream 1.5% BID during the vehicle-controlled period (Day 1 to Week 24).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52	Week 24 to Week 52	Safety Population. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Analysis was conducted in participants who were randomized to ruxolitinib cream 0.15% QD and vehicle groups in the vehicle-controlled period (Day 1 to Week 24) and then had a dose in the continued double-blind period (Week 24 to Week 52).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE	up to Week 156	Safety Population. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Analysis was only conducted in participants who received ruxolitinib cream 1.5% BID on Day 1.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156	Week 52 to Week 156	Open-label Evaluable Population: all randomized participants who received at least 1 dose of study drug in the Open-label Period	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change From Baseline in F-VASI Score at Week 24	Baseline; Week 24	ITT Population. Only participants with available data were analyzed. Mixed-model for Repeated Measures (MMRM) model for post-Baseline measures: (response variable = treatment + stratification factor \[age ≤30 versus \>30\] + visit + treatment\*visit). All post-Baseline visits up to Week 24 were included in the model.	scores on a scale	LEAST_SQUARES_MEAN

1 to 10 of 49Source ClinicalTrials.gov

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Results by group1,141

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24	Vehicle Twice Daily (BID)	3.1	percentage of participants
Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24	Ruxolitinib Cream 0.15% QD	32.3	percentage of participants
Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24	Ruxolitinib Cream 0.5% QD	25.8	percentage of participants
Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24	Ruxolitinib Cream 1.5% QD	50.0	percentage of participants
Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24	Ruxolitinib Cream 1.5% BID	45.5	percentage of participants
Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear	Vehicle Twice Daily (BID)	0	percentage of participants
Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear	Ruxolitinib Cream 0.15% QD	3.2	percentage of participants
Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear	Ruxolitinib Cream 0.5% QD	9.7	percentage of participants
Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear	Ruxolitinib Cream 1.5% QD	13.3	percentage of participants
Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear	Ruxolitinib Cream 1.5% BID	9.1	percentage of participants

1 to 10 of 1,141Source ClinicalTrials.gov

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Participant flow54

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
DB Period: Day 1 to Week 24	STARTED	Vehicle Twice Daily (BID)	32
DB Period: Day 1 to Week 24	STARTED	Ruxolitinib Cream 0.15% QD	31
DB Period: Day 1 to Week 24	STARTED	Ruxolitinib Cream 0.5% QD	31
DB Period: Day 1 to Week 24	STARTED	Ruxolitinib Cream 1.5% QD	30
DB Period: Day 1 to Week 24	STARTED	Ruxolitinib Cream 1.5% BID	33
DB Period: Day 1 to Week 24	STARTED	Cross-over	0
DB Period: Day 1 to Week 24	COMPLETED	Vehicle Twice Daily (BID)	27
DB Period: Day 1 to Week 24	COMPLETED	Ruxolitinib Cream 0.15% QD	26
DB Period: Day 1 to Week 24	COMPLETED	Ruxolitinib Cream 0.5% QD	30
DB Period: Day 1 to Week 24	COMPLETED	Ruxolitinib Cream 1.5% QD	26

1 to 10 of 54Source ClinicalTrials.gov

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Adverse events140

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Vehicle Twice Daily (BID)	2	32	2
other	Abdominal pain	Gastrointestinal disorders	Ruxolitinib Cream 0.15% Once Daily (QD)	0	31	0
other	Abdominal pain	Gastrointestinal disorders	Ruxolitinib Cream 0.5% QD	1	45	1
other	Abdominal pain	Gastrointestinal disorders	Ruxolitinib Cream 1.5% QD	0	44	0
other	Abdominal pain	Gastrointestinal disorders	Ruxolitinib Cream 1.5% BID	2	130	2
other	Acne	Skin and subcutaneous tissue disorders	Vehicle Twice Daily (BID)	1	32	7
other	Acne	Skin and subcutaneous tissue disorders	Ruxolitinib Cream 0.15% Once Daily (QD)	4	31	4
other	Acne	Skin and subcutaneous tissue disorders	Ruxolitinib Cream 0.5% QD	5	45	12
other	Acne	Skin and subcutaneous tissue disorders	Ruxolitinib Cream 1.5% QD	4	44	5
other	Acne	Skin and subcutaneous tissue disorders	Ruxolitinib Cream 1.5% BID	12	130	14

1 to 10 of 140Source ClinicalTrials.gov

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Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vehicle Twice Daily (BID)	0	32
Total, all-cause mortality	Ruxolitinib Cream 0.15% Once Daily (QD)	0	31
Total, all-cause mortality	Ruxolitinib Cream 0.5% QD	0	45
Total, all-cause mortality	Ruxolitinib Cream 1.5% QD	0	44
Total, all-cause mortality	Ruxolitinib Cream 1.5% BID	0	130
Total, other adverse events	Vehicle Twice Daily (BID)	14	32
Total, other adverse events	Ruxolitinib Cream 0.15% Once Daily (QD)	19	31
Total, other adverse events	Ruxolitinib Cream 0.5% QD	23	45
Total, other adverse events	Ruxolitinib Cream 1.5% QD	20	44
Total, other adverse events	Ruxolitinib Cream 1.5% BID	45	130

1 to 10 of 15Source ClinicalTrials.gov

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Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32653055	DERIVED	PubMed
37840766	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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