VitiligoPhase 2NCT05247489
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
A Phase 2 study testing Ruxolitinib 1.5% cream and NB-UVB phototherapy in people with Vitiligo, run by Incyte Corporation at 13 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA). Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Ruxolitinib 1.5% cream and NB-UVB phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 5 May 2022to 19 Dec 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 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the following:
- ≥ 0.5 F-VASI on the face
- ≥ 3.0 T-VASI (body areas not including the face)
- Total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
- 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.
- Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
- Previous adverse reaction to NB-UVB phototherapy that caused discontinuation of therapy.
- Lack of response (little or no repigmentation) to prior NB-UVB phototherapy.
- History of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke, myocardial infarction).
Show all 12Show fewer
- Any other skin disease that, in the opinion of the investigator, would interfere with the study cream application or study assessments.
- Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox) within 1 week before baseline.
- Any serious illness or medical, physical, or psychiatric condition(s) that pose a significant risk to the participant; or interfere with interpretation of study data.
- Recent use of topical or systemic medications (including biologics or JAK inhibitors), or laser or phototherapy to treat vitiligo. Note: Recent may be defined differently for different treatments.
- Specific protocol-defined chemistry, hematology, and serological lab values.
- Those who are pregnant, lactating or considering pregnancy during the period of study participation.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Delricht Clinical Research - Clinedge - Ppds Baton Rouge
Baton Rouge, Louisiana, 70809
Tufts Medical Center
Boston, Massachusetts, 02111
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
First Oc Dermatology
Fountain Valley, California, 92708
Austin Institute For Clinical Research Aicr Pflugerville
Pflugerville, Texas, 78660
Aesthetic and Dermatology Center
Rockville, Maryland, 20850
UC Davis Health
Sacramento, California, 95816
Principle Research Solutions
Spokane, Washington, 99202
Palo Alto Medical Foundation
Sunnyvale, California, 94086
University of Massachusetts Medical School
Worcester, Massachusetts, 01605
Canada2 sites
Simcomed Health Ltd
Barrie, Ontario, L4M 7G1
Lynderm Research Inc
Markham, Ontario, L3P 1X2
About this study
Official title: A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
- Conditions
- Vitiligo
- Being tested
- Ruxolitinib 1.5% cream, NB-UVB phototherapy
- Keywords
- Non-segmental, Vitiligo, hypopigmentation, Pigment Disorders, Skin Diseases, JAK inhibitor
- Medical subject headings
- Vitiligo, Hypopigmentation, Pigmentation Disorders, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib 1.5% creamDrug
Ruxolitinib cream 1.5% applied twice a day (BID).
NB-UVB phototherapyDevice
Also called Narrow-Band Ultraviolet B Phototherapy
NB-UVB (311-312 nm) phototherapy is an established treatment modality for vitiligo. Starting dose will be 200 mJ/cm2 and dose may be increased by 10% at each visit
| Study group | Role | What they receive |
|---|---|---|
| Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB) | Experimental | Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have < 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study. Receives: Drug: Ruxolitinib 1.5% cream; Device: NB-UVB phototherapy |
| Group B: Ruxolitinib Monotherapy | Experimental | Participants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone. Receives: Drug: Ruxolitinib 1.5% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48
T-VASI was calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of body surface area [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 body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).
Measured: Baseline; Week 48
Secondary outcomes (16)
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 is 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 study cream. 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: up to approximately 52 weeks
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit
An F-VASI50 responder achieved at least 50% 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).
Measured: Baseline; up to Week 48
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit
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).
Measured: Baseline; up to Week 48
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit
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).
Measured: Baseline; up to Week 48
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit
A T-VASI50 responder achieved ≥50% improvement from Baseline in T-VASI, calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA 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 percent BSA vitiligo involvement. The degree of depigmentation for each body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).
Measured: Baseline; up to Week 48
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit
A T-VASI75 responder achieved ≥75% improvement from Baseline in T-VASI, calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA 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 percent BSA vitiligo involvement. The degree of depigmentation for each body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).
Measured: Baseline; up to Week 48
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit
A T-VASI90 responder achieved ≥90% improvement from Baseline in T-VASI, calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA 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 percent BSA vitiligo involvement. The degree of depigmentation for each body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).
Measured: Baseline; up to Week 48
Change From Baseline in F-VASI at Each Post-Baseline Visit
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.
Measured: Baseline; up to Week 48
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit
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-Baseline (BL) value minus BL value]/BL value) X 100.
Measured: Baseline; up to Week 48
Change From Baseline in T-VASI at Each Post-Baseline Visit
T-VASI was calculated with contributions from 6 body 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 body 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). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from BL was calculated as the post-BL value minus the BL value.
Measured: Baseline; up to Week 48
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit
T-VASI was calculated with contributions from 6 body 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 body 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). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100.
Measured: Baseline; up to Week 48
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to Week 48
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100.
Measured: Baseline; up to Week 48
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to Week 48
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100.
Measured: Baseline; up to Week 48
Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16
The concentration of ruxolitinib in the plasma was assessed.
Measured: pre-application at Weeks 4, 12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start5 May 2022
- Primary completion19 Dec 2023
- Study completion19 Dec 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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haq Nawaz, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247489
- Sponsor's protocol ID
- INCB 18424-217
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2022
- Last updated
- 20 Feb 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo
- ClinicalTrials.gov ID
- NCT05247489
- Acronym / sponsor ID
- INCB 18424-217
- Conditions
- Vitiligo
- Keywords
- Non-segmental, Vitiligo, hypopigmentation, Pigment Disorders, Skin Diseases, JAK inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Posted 20 Feb 2025
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 this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB) | Experimental | Drug: Ruxolitinib 1.5% cream, Device: NB-UVB phototherapyParticipants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have < 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study. |
| Group B: Ruxolitinib Monotherapy | Experimental | Drug: Ruxolitinib 1.5% creamParticipants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone. |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the following:
- 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 (12 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.
- Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
- Previous adverse reaction to NB-UVB phototherapy that caused discontinuation of therapy.
- Lack of response (little or no repigmentation) to prior NB-UVB phototherapy.
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 1.5% creamRuxolitinib cream 1.5% applied twice a day (BID). | Drug | Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB), Group B: Ruxolitinib Monotherapy |
| NB-UVB phototherapyAlso: Narrow-Band Ultraviolet B PhototherapyNB-UVB (311-312 nm) phototherapy is an established treatment modality for vitiligo. Starting dose will be 200 mJ/cm2 and dose may be increased by 10% at each visit | Device | Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB) |
Primary outcome
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48
Time frame: Baseline; Week 48
T-VASI was calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of body surface area [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 body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).
16 secondary outcomes
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to approximately 52 weeks
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Change From Baseline in F-VASI at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Change From Baseline in T-VASI at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit
Time frame: Baseline; up to Week 48
Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16
Time frame: pre-application at Weeks 4, 12, and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
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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.
Haq Nawaz, MD study director
Incyte Corporation
13 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 Ruxolitinib 1.5% cream and NB-UVB phototherapy in people with Vitiligo, run by Incyte Corporation at 13 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 12 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 20 Feb 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. 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. 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 20 Feb 2025). 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?
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48 (time frame: Baseline; Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2025.