Vitiligo
A Study to evaluate the mechanism of action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
Incyte Study ID:
INCB 18424-214
CT.gov ID:
Eudra ID:
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Results Available
Protocol
Available Languages: English
Statistical Analysis Plan (SAP)
Available Languages: English
Clinical Study Purpose
The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jun 2021 - Jul 2023
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
Contact UsName
FIRST OC DERMATOLOGY
FOUNTAIN VALLEY, CA, US, 92708
Name
DERMATOLOGY SPECIALISTS OF SPOKANE
SPOKANE, WA, US, 99202
Name
DERMATOLOGY RESEARCH INSTITUTE
CALGARY, AB, Canada, T1Y 0B4
Name
JRB RESEARCH INC
OTTAWA, ON, Canada, K1H 7X8
Name
SIMCODERM MEDICAL AND SURGICAL DERMATOLOGY CENTER
BARRIE, ON, Canada, L4M 7G1
Name
LYNDERM RESEARCH INC
MARKHAM, ON, Canada, L3P 1X2
Go to page
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
- At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish
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 (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
Requirements information
Inclusion Criteria
- A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
- At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish
- rim, or other evidence of inflammatory activity) at the site for skin biopsy.
- 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 (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
- Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
- Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
- Conditions at baseline that would interfere with evaluation of vitiligo.
- Use of any protocol-defined treatments within the indicated washout period before baseline.
Protocol Summary
Incyte Study ID:
INCB 18424-214
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Interventions:
Enrollment:
60
Primary Outcome
Open
To evaluate change in Immune Biomarkers
Timeframe: First 24 weeks of study
Secondary Outcome
Open
Correlation of CXCL10 biomarker to Vitiligo Area Scoring Index (VASI) Repigmentation response in target lesions
Timeframe: First 24 weeks of study
Number of treatment emergency Adverse Events
Timeframe: 56 weeks