Back to resultsA Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
Primary Purpose
Vitiligo
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib 1.5% cream
NB-UVB phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring Non-segmental, Vitiligo, hypopigmentation, Pigment Disorders, Skin Diseases, JAK inhibitor
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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).
- 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.
Sites / Locations
- First Oc Dermatology
- UC Davis Health
- Palo Alto Medical Foundation
- Delricht Clinical Research - Clinedge - Ppds Baton Rouge
- Aesthetic and Dermatology Center
- Tufts Medical Center
- Metro Boston Clinical Partners
- University of Massachusetts Medical School
- Henry Ford Medical Center - New Center One
- Austin Institute For Clinical Research Aicr Pflugerville
- Principle Research Solutions
- Simcomed Health Ltd
- Lynderm Research Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)
Group B: Ruxolitinib Monotherapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from Baseline in T-VASI
T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Secondary Outcome Measures
Number of treatment-related adverse events
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Percentage of participants achieving F-VASI50/75/90 at each post-baseline visit
Defined as ≥ 50/75/90% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI) score. Facial VASI is measured by percentage of vitiligo involvement (%BSA) and the degree of depigmentation.
Percentage of participants achieving T-VASI50/75/90 at each post-baseline visit
Defined as ≥ 50/75/90% improvement from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) score. T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Percentage change from baseline in F-VASI at each post-baseline visit
Face Vitiligo Area Scoring Index (F-VASI) score is measured by percentage of vitiligo involvement (%BSA) and the degree of depigmentation.
Percentage change from baseline in T-VASI at each post-baseline visit
T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Percentage change from baseline in F-BSA at each post-baseline visit
Facial BSA (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Percentage change from baseline in T-BSA at each post-baseline visit
Total BSA (T-BSA) takes into account the depigmented areas for each of the following body regions: head/neck (including scalp), upper extremities (including axillae), hands, trunk (including genitalia), lower extremities (including buttocks), and feet. Body surface area assessment will be performed by the Palmar Method.
Population-based (trough) plasma concentrations of ruxolitinib
Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Full Information
NCT ID
NCT05247489
First Posted
February 10, 2022
Last Updated
September 14, 2023
Sponsor
Incyte Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05247489
Brief Title
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
Official Title
A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
January 23, 2024 (Anticipated)
Study Completion Date
January 23, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Non-segmental, Vitiligo, hypopigmentation, Pigment Disorders, Skin Diseases, JAK inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B: Ruxolitinib Monotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib 1.5% cream
Intervention Description
Ruxolitinib cream 1.5% applied twice a day (BID).
Intervention Type
Device
Intervention Name(s)
NB-UVB phototherapy
Other Intervention Name(s)
Narrow-Band Ultraviolet B Phototherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline in T-VASI
Description
T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Number of treatment-related adverse events
Description
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
Approximately 14 months
Title
Percentage of participants achieving F-VASI50/75/90 at each post-baseline visit
Description
Defined as ≥ 50/75/90% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI) score. Facial VASI is measured by percentage of vitiligo involvement (%BSA) and the degree of depigmentation.
Time Frame
Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Title
Percentage of participants achieving T-VASI50/75/90 at each post-baseline visit
Description
Defined as ≥ 50/75/90% improvement from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) score. T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Time Frame
Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Title
Percentage change from baseline in F-VASI at each post-baseline visit
Description
Face Vitiligo Area Scoring Index (F-VASI) score is measured by percentage of vitiligo involvement (%BSA) and the degree of depigmentation.
Time Frame
Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Title
Percentage change from baseline in T-VASI at each post-baseline visit
Description
T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Time Frame
Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Title
Percentage change from baseline in F-BSA at each post-baseline visit
Description
Facial BSA (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Time Frame
Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Title
Percentage change from baseline in T-BSA at each post-baseline visit
Description
Total BSA (T-BSA) takes into account the depigmented areas for each of the following body regions: head/neck (including scalp), upper extremities (including axillae), hands, trunk (including genitalia), lower extremities (including buttocks), and feet. Body surface area assessment will be performed by the Palmar Method.
Time Frame
Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Title
Population-based (trough) plasma concentrations of ruxolitinib
Description
Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Time Frame
Weeks 4, 12, and 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haq Nawaz, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
First Oc Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Palo Alto Medical Foundation
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
Delricht Clinical Research - Clinedge - Ppds Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Aesthetic and Dermatology Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Metro Boston Clinical Partners
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Henry Ford Medical Center - New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Austin Institute For Clinical Research Aicr Pflugerville
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Principle Research Solutions
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Simcomed Health Ltd
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
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