Trial · NCT04818346
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
NCT04818346, Phase 2, Completed, Incyte Corporation; results first posted 2023-07-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo. Trials, record NCT04818346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04818346
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
- NCT number
- NCT04818346
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 171 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- NonSegmental Vitiligo
- Interventions
- INCB054707, Placebo
- First posted
- 2021-03-26
- Last updated
- 2024-04-11
- Results first posted
- 2023-07-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | 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. |
| Secondary | Percentage of Participants Achieving T-VASI50 at Week 24 | Baseline; 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. |
| Secondary | Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to Week 24 | 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. |
| Secondary | Extension Period: Number of Participants With Any TEAE | from Week 25 up to Week 76 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | Baseline; Week 24 | 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. | percent change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving T-VASI50 at Week 24 | Baseline; Week 24 | Intent-to-Treat Population. The 95% confidence interval was based on the Clopper-Pearson exact method. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to Week 24 | Safety Population: all participants who received at least 1 dose of study drug. Treatment groups for this population were to have been determined according to the actual treatment the participant received on Day 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Extension Period: Number of Participants With Any TEAE | from Week 25 up to Week 76 | Extension Evaluable Population: all participants who received at least 1 dose of povorcitinib during the double-blind extension period | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | Placebo | 2.29 | Standard Error 4.81 | percent change | |
| Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | Povorcitinib 15 mg | -19.12 | Standard Error 4.56 | percent change | |
| Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | Povorcitinib 45 mg | -17.78 | Standard Error 4.87 | percent change | |
| Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | Povorcitinib 75 mg | -15.73 | Standard Error 4.74 | percent change | |
| Percentage of Participants Achieving T-VASI50 at Week 24 | Placebo | 2.3 | 95% Confidence Interval 0.1 to 12.3 | percentage of participants | |
| Percentage of Participants Achieving T-VASI50 at Week 24 | Povorcitinib 15 mg | 9.3 | 95% Confidence Interval 2.6 to 22.1 | percentage of participants | |
| Percentage of Participants Achieving T-VASI50 at Week 24 | Povorcitinib 45 mg | 11.6 | 95% Confidence Interval 3.9 to 25.1 | percentage of participants | |
| Percentage of Participants Achieving T-VASI50 at Week 24 | Povorcitinib 75 mg | 4.8 | 95% Confidence Interval 0.6 to 16.2 | percentage of participants | |
| Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Placebo | 24 | Participants | ||
| Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Povorcitinib 15 mg | 29 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 24-Week Placebo-controlled Period | STARTED | Placebo | 43 | |
| 24-Week Placebo-controlled Period | STARTED | Povorcitinib 15 mg | 43 | |
| 24-Week Placebo-controlled Period | STARTED | Povorcitinib 45 mg | 43 | |
| 24-Week Placebo-controlled Period | STARTED | Povorcitinib 75 mg | 42 | |
| 24-Week Placebo-controlled Period | COMPLETED | Placebo | 35 | |
| 24-Week Placebo-controlled Period | COMPLETED | Povorcitinib 15 mg | 38 | |
| 24-Week Placebo-controlled Period | COMPLETED | Povorcitinib 45 mg | 32 | |
| 24-Week Placebo-controlled Period | COMPLETED | Povorcitinib 75 mg | 34 | |
| 24-Week Placebo-controlled Period | NOT COMPLETED | Placebo | 8 | |
| 24-Week Placebo-controlled Period | NOT COMPLETED | Povorcitinib 15 mg | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events92
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 | Acne | Skin and subcutaneous tissue disorders | Placebo | 0 | 42 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Povorcitinib 15 mg | 0 | 43 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Povorcitinib 45 mg | 3 | 41 | 3 |
| other | Acne | Skin and subcutaneous tissue disorders | Povorcitinib 75 mg | 22 | 114 | 28 |
| other | Alanine aminotransferase increased | Investigations | Placebo | 1 | 42 | 1 |
| other | Alanine aminotransferase increased | Investigations | Povorcitinib 15 mg | 1 | 43 | 1 |
| other | Alanine aminotransferase increased | Investigations | Povorcitinib 45 mg | 3 | 41 | 3 |
| other | Alanine aminotransferase increased | Investigations | Povorcitinib 75 mg | 6 | 114 | 6 |
| other | Aspartate aminotransferase increased | Investigations | Placebo | 1 | 42 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Povorcitinib 15 mg | 1 | 43 | 1 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 42 |
| Total, all-cause mortality | Povorcitinib 15 mg | 0 | 43 |
| Total, all-cause mortality | Povorcitinib 45 mg | 0 | 41 |
| Total, all-cause mortality | Povorcitinib 75 mg | 0 | 114 |
| Total, other adverse events | Placebo | 19 | 42 |
| Total, other adverse events | Povorcitinib 15 mg | 22 | 43 |
| Total, other adverse events | Povorcitinib 45 mg | 24 | 41 |
| Total, other adverse events | Povorcitinib 75 mg | 69 | 114 |
| Total, serious adverse events | Placebo | 1 | 42 |
| Total, serious adverse events | Povorcitinib 15 mg | 0 | 43 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04818346
GET https://conductscience.org/api/trials/v1/NCT04818346/flow?page=2