Topical Ruxolitinib for the Treatment of Vitiligo

NCT02809976 | Completed Phase 2 Results

• 1 other identifier: I-18424-15-06
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if topical ruxolitinib 1.5% will provide repigmentation in vitiligo lesions.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Percent Change in Vitiligo Area Severity Index (VASI) Score From Baseline to Week 20

  The VASI for each body region (hands, upper extremities, trunk, lower extremities, feet) is determined by the product of the area involved in hand prints and the extent of depigmentation within each hand print unit measured patch (0-100). Area involved is measured by hand prints (1 hand print = 1%) with a possible range of 0-100. Degree of depigmentation is measured as: 1.00 (100%) = complete depigmentation, no pigment present, 0.90(90%)=specks of pigment present, 0.75(75%)=depigmented area exceeds the pigmented area, 0.50(50%)=pigmented and depigmented areas are equal, 0.25(25%)=pigmented area exceeds depigmented area, 0.10(10%)=only specks of depigmentation present, and 0.0(0%)=no depigmentation present.

  Baseline to Week 20

Secondary Outcomes (6)

• Percent Change in Body Surface Area (BSA) of Repigmentation

  Baseline and Week 20

• Number of Subjects Who Achieve a Physician Global Vitiligo Assessment (PGVA) of Clear or Almost Clear

  Baseline and Week 20

• Percent Change in Vitiligo European Task Force (VETF) Assessment - Body Surface Area

  Baseline and Week 20

• Mean Dermatology Life Quality Index (DLQI) Scores

  Baseline and Week 20

• Percent Change in Vitiligo European Task Force (VETF) Assessment - Disease Staging

  Baseline and Week 20

Study Arms (1)

Ruxolitinib 1.5% phosphate cream

EXPERIMENTAL

Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches.

Drug: Ruxolitinib 1.5% Phosphate Cream

Interventions

Ruxolitinib 1.5% Phosphate Cream DRUG

twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20

Also known as: INCB018424 phosphate cream

Ruxolitinib 1.5% phosphate cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of vitiligo.
• At Visit 1 (Baseline/Day 1), have had vitiligo covering at least 1% of total body surface area (BSA) on the scalp, trunk or limbs (excluding nails).
• Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least four weeks after the last dose of assigned treatment. Male subjects must also use contraception, such as barrier method with spermicide.
• If receiving concomitant medications for any reason, must be on a stable regimen and willing to stay on a stable regimen.
• Must be willing to washout of other vitiligo treatments. All treatments for vitiligo are prohibited during the course of the study.

You may not qualify if:

• Other skin conditions at Baseline that would interfere with evaluation of vitiligo.
• Pregnant/breastfeeding females, or females of childbearing potential not using highly effective contraception. Women of childbearing potential must test negative for pregnancy and use contraception for at least four weeks after last dose of drug.
• Current or recent history of clinically significant medical/psychiatric condition or laboratory abnormality that may increase risk associated with the study participation or drug administration.
• Have a history of any lymphoproliferative disorder, lymphoma, leukemia, history of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
• Have a history of infection requiring parenteral or oral or topical antimicrobial therapy within 2 weeks prior to Baseline.
• Vaccinated with live/attenuated live vaccine within 6 weeks prior to Baseline.
• Previously participated in study of oral/topical ruxolitinib or tofacitinib (tofacitinib, CP-690,550, formerly tasocitinib) unless confirmed to have been randomized to and treated with placebo or placebo topical formulation (vehicle) only.
• Received a prohibited concomitant medication within 7 days or 5 half-lives (whichever is longer) prior to Baseline.
• Have participated in other studies within 4 weeks or 5 half-lives (whichever is longer) prior to Visit 1 (Baseline/Day 1). Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
• Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Sponsor employees directly involved in the conduct of the trial.
• In the opinion of the investigator or Sponsor, the subject is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle guidelines.
• Screening laboratory abnormalities

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Vitiligo

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: David Romarin, MD Prinicpal Investigator
• Organization: Tufts Medical Center

drosmarin@tuftsmedicalcenter.org

617 636 7462

Study Officials

• David Rosmarin, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 31, 2020
• Results First Posted: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)