A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)

Vitiligo Clinical Trial

Official title:

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04896385
• Other study ID #: INCB 18424-214
• Status: Completed
• Phase: Phase 2
• Start date: June 23, 2021
• Est. completion date: July 10, 2023

Study information

• Verified date: April 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 10, 2023
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
• Vehicle Cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Locations

Country	Name	City	State
Canada	Simcoderm Medical and Surgical Dermatology Center	Barrie	Ontario
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	Lynderm Research Inc	Markham	Ontario
Canada	JRB Research Inc	Ottawa	Ontario
France	Hopital Saint Andre	Bordeaux
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Hopital Archet 2 Derm Dept	Nice
United States	Suny Downstate Medical Center	Brooklyn	New York
United States	First Oc Dermatology	Fountain Valley	California
United States	UC Irvine	Irvine	California
United States	Mount Sinai Hospital	New York	New York
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	George Washington Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24	Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value)*100.	Baseline; Week 4, Week 12, and Week 24
Secondary	Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts	Clinical scores (facial Vitiligo Area Scoring Index [F-VASI] and total body Vitiligo Area Scoring Index [T-VASI]) were evaluated for correlation with skin CXCL10 levels.	Baseline, Week 12, and Week 24
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could 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 drug. 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.	from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
Secondary	Number of Participants With TEAEs During the Treatment-Extension Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could 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 drug. 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.	from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days
Secondary	Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. 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. AE severity was assessed per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.	from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
Secondary	Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. 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. AE severity was assessed per the CTCAE, version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.	from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days