Trial · NCT04530344
Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
NCT04530344, Phase 3, Completed, Incyte Corporation; results first posted 2023-07-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo. Trials, record NCT04530344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04530344
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
- NCT number
- NCT04530344
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 458 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Vitiligo
- Interventions
- ruxolitinib, Vehicle
- First posted
- 2020-08-28
- Last updated
- 2025-08-14
- Other registries' IDs
- eudract:2020-000987-53
- Results first posted
- 2023-07-19
- Limitations and caveats
Data from participants at a single site (N = 2) were removed from all efficacy analyses performed on the ITT-Ext Population and FAS Cohort A owing to noncompliance with the Protocol in the parent study resulting in serious concerns with data quality.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Relapse (Defined as <F-VASI75) | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) | Relapse was defined as a loss of 75% improvement from Baseline in the Face Vitiligo Area Scoring Index score (F-VASI75) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<75%. |
| Secondary | Time to Loss of Adequate Response | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) | Loss of adequate response was defined as a loss of 90% improvement from Baseline in the F-VASI score (F-VASI90) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<90%. |
| Secondary | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | 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 Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, 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). |
| Secondary | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | An F-VASI90 responder achieved at least 90% improvement from Baseline in F-VASI, 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). |
| Secondary | Mean F-VASI Scores During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | 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). |
| Secondary | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | 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. |
| Secondary | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | 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). Percentage change = (\[post-BL value minus BL value\]/BL value) X 100. |
| Secondary | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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 percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 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 then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Secondary | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | A T-VASI75 responder achieved at least 75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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 percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 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 then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Relapse (Defined as <F-VASI75) | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) | Intent-to-Treat Long-term Extension (ITT-Ext) Population: randomized participants who achieved ≥90% improvement from Baseline in the F-VASI score (≥F-VASI90) at Week 52. Treatment groups were defined according to the treatment assignment at randomization regardless of the actual study medication the participant received. Week 52 was the first visit of this Treatment Extension study (visits were named to reflect continuation from the parent studies). Only participants in Cohort A were analyzed. | days | MEDIAN |
| SECONDARY | Time to Loss of Adequate Response | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) | ITT-Ext Population. Week 52 was the first visit of this Treatment Extension study (visits were named to reflect continuation from the parent studies). Only participants in Cohort A were analyzed. | days | MEDIAN |
| SECONDARY | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | Full Analysis Set (FAS) without non-compliant site: all participants who received at least 1 dose of study drug at or after Week 52 (Baseline of Treatment Extension study). For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Mean F-VASI Scores During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group709
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Relapse (Defined as <F-VASI75) | Cohort A: Vehicle Cream BID | NA | 95% Confidence Interval 238.0 to NA | days | |
| Time to Relapse (Defined as <F-VASI75) | Cohort A: Ruxolitinib 1.5% Cream BID | NA | 95% Confidence Interval NA to NA | days | |
| Time to Loss of Adequate Response | Cohort A: Vehicle Cream BID | 195.0 | 95% Confidence Interval 113.0 to 372.0 | days | |
| Time to Loss of Adequate Response | Cohort A: Ruxolitinib 1.5% Cream BID | NA | 95% Confidence Interval NA to NA | days | |
| Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Cohort A: Vehicle Cream BID | Week 52 | 98.2 | 95% Confidence Interval 90.6 to 100.0 | percentage of participants |
| Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Cohort A: Ruxolitinib 1.5% Cream BID | Week 52 | 98.2 | 95% Confidence Interval 90.6 to 100.0 | percentage of participants |
| Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Week 52 | 45.8 | 95% Confidence Interval 36.6 to 55.2 | percentage of participants |
| Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Week 52 | 65.6 | 95% Confidence Interval 58.9 to 71.9 | percentage of participants |
| Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Cohort A: Vehicle Cream BID | Week 56 | 98.2 | 95% Confidence Interval 90.4 to 100.0 | percentage of participants |
| Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Cohort A: Ruxolitinib 1.5% Cream BID | Week 56 | 96.4 | 95% Confidence Interval 87.5 to 99.6 | percentage of participants |
1 to 10 of 709Source ClinicalTrials.gov
See all 709 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Vehicle Cream BID | 58 | |
| Overall Study | STARTED | Cohort A: Ruxolitinib 1.5% Cream BID | 58 | |
| Overall Study | STARTED | Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 118 | |
| Overall Study | STARTED | Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 224 | |
| Overall Study | COMPLETED | Cohort A: Vehicle Cream BID | 41 | |
| Overall Study | COMPLETED | Cohort A: Ruxolitinib 1.5% Cream BID | 50 | |
| Overall Study | COMPLETED | Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 92 | |
| Overall Study | COMPLETED | Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 173 | |
| Overall Study | NOT COMPLETED | Cohort A: Vehicle Cream BID | 17 | |
| Overall Study | NOT COMPLETED | Cohort A: Ruxolitinib 1.5% Cream BID | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events51
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 | COVID-19 | Infections and infestations | Vehicle Cream BID | 6 | 58 | 6 |
| other | COVID-19 | Infections and infestations | Ruxolitinib 1.5% Cream BID | 55 | 423 | 57 |
| other | COVID-19 | Infections and infestations | Total | 61 | 458 | 63 |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Vehicle Cream BID | 0 | 58 | 0 |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Ruxolitinib 1.5% Cream BID | 1 | 423 | 1 |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Total | 1 | 458 | 1 |
| serious | Angina pectoris | Cardiac disorders | Vehicle Cream BID | 0 | 58 | 0 |
| serious | Angina pectoris | Cardiac disorders | Ruxolitinib 1.5% Cream BID | 1 | 423 | 1 |
| serious | Angina pectoris | Cardiac disorders | Total | 1 | 458 | 1 |
| serious | Bipolar I disorder | Psychiatric disorders | Vehicle Cream BID | 0 | 58 | 0 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle Cream BID | 0 | 58 |
| Total, all-cause mortality | Ruxolitinib 1.5% Cream BID | 0 | 423 |
| Total, all-cause mortality | Total | 0 | 458 |
| Total, other adverse events | Vehicle Cream BID | 6 | 58 |
| Total, other adverse events | Ruxolitinib 1.5% Cream BID | 55 | 423 |
| Total, other adverse events | Total | 61 | 458 |
| Total, serious adverse events | Vehicle Cream BID | 0 | 58 |
| Total, serious adverse events | Ruxolitinib 1.5% Cream BID | 12 | 423 |
| Total, serious adverse events | Total | 12 | 458 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41125994 | DERIVED |
Source 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.
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.
For software
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