Topical Ruxolitinib Evaluation in Immune-related Vitiligo-like Depigmentation

NCT07725432 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2023-01552
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

White spot disease is a common side effect on the skin in the context of cancer treatments with immunotherapies. There is no standard therapy yet for white spot caused by cancer therapies. There is already research in humans on the treatment of white spot disease. Previous human studies with ruxolitinib cream have shown that approximately 30% of patients with white spot disease have achieved a 75% improvement (re-pigmentation) of their affected areas after 24 weeks and approximately 50% of patients have achieved a 75% improvement after 52 weeks. It is also know that a 50% improvement was observed in over 50% of patients after 24 weeks and a 90% improvement in over 15% of patients. However, these studies to date have not included patients with white spot disease caused by cancer therapy. Therefore, we do not know how well the cream works in this situation. In this study, the investigators are therefore examining whether the investigational substance ruxolitinib is effective and well tolerated in white spot disease caused by cancer therapy. The test substance has not yet been approved in Switzerland. Only once the efficacy of the investigational substance ruxolitinib has been scientifically investigated and proven can it be approved in Switzerland and used to treat white spot disease caused by cancer therapy.

Conditions

Immune-related Vitiligo-like-Depigmentation

Keywords

Vitiligo; White spot disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving a Facial vitiligo scoring index of 75% (F-VASI75) at week 24

  The F-VASI is a measure for assessing the success of treatment. The F-VASI assesses the percentage of repigmentation on the face. Achieving an F-VASI of 75% means that a 75% improvement in facial repigmentation has been achieved. This is determined by visually assessing the percentage of skin area that has returned to its normal color as a result of the treatment. The F-VASI is made up of the degree of depigmentation in percent and the size of the affected skin surface in percent. Percentage of depigmentation (0% = no depigmentation present, 100% = completely depigmented skin) is multiplied by the size of the affected skin area on the face in percent.

  week 24

Secondary Outcomes (17)

• Proportion of patients achieving a F-VASI of 25%, 50% and 90% (F-VASI25/50/90)

  week 24 and 52

• Proportion of patients achieving a F-VASI 75 only at week 52

  week 52

• Proportion of patients achieving a Total Vitiligo Area Scoring Index of 25%, 50%, 75% and 90% (T-VASI25/50/75/90)

  week 24 and 52

• Proportion of patients achieving 4 points ("a lot less noticeable") or 5 points ("no longer noticeable") in the Vitiligo Noticeability Scale (VNS)

  week 24 and 52

• Percentage change from baseline in the Facial Body Surface Area (F-BSA) and Total Body Surface Area (T-BSA)

  week 24 and 52

Other Outcomes (1)

• Assessment of skin shave biopsies

  Baseline and week 52

Study Arms (1)

Topical ruxolitinib

EXPERIMENTAL

This study will be performed as one-arm with no comparator.

Drug: Ruxolitinib Topical Cream

Interventions

Ruxolitinib Topical Cream DRUG

Ruxolitinib cream 1.5% will be applied topically twice daily over 52 weeks in patients with immune-related vitiligo-like depigmentation.

Also known as: Topical Ruxolitinib (OPZELURA)

Topical ruxolitinib

Eligibility Criteria

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

You may qualify if:

• Age 18 years
• Written informed consent of the patient
• Sufficient fluency in German language skills to complete all questionnaires of the study without external assistance
• Treatment-related, immune-related vitiligo-like depigmentation of at least 5% body surface area of one region (face or one upper or lower extremity or front or back side of the trunk)
• Female participants must use effective contraceptives, either: An ovulation-inhibiting method (e.g., pill, injectable, implant, patch, or vaginal ring) or an intrauterine device (IUD). Contraception should extend one week post-study. If pregnancy occurs during or within one week after the study, participants should notify the overseeing physician immediately.
• During participation in the study and up to one week afterwards, male participants may only have sexual intercourse with condoms. Female partners of male participants must use a highly effective contraceptive method during the partner's participation in the study and for up to 1 week afterwards

You may not qualify if:

• Acute psychiatric illness (except mild to moderate depression)
• Contraindications to ruxolitinib, e.g. known hypersensitivity or allergy
• Use of topical glucocorticosteroids, topical calcineurin inhibitors, UV light therapy, therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine are not allowed during the study period (no wash out period required).
• Women who are pregnant or breast feeding
• Intention to become pregnant during the course of the study
• Known or suspected non-compliance, drug or alcohol abuse.
• Patients with an active, serious infection, including localized infections.
• Inability to follow the procedures of the study due to language problems, psychological disorders, dementia of the participant.
• Participation in another trial with topical or oral ruxolitinib within the 30 days preceding and during the present study.
• Simultaneously participation in clinical trials with intervention with a drug other than ruxolitinib (except registry studies)
• Previous enrolment into the current study.
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Universitätsspital Zürich

Zurich, 8058, Switzerland

Location

MeSH Terms

Conditions

Vitiligo; Lichen Sclerosus et Atrophicus

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Model Details: Prospective, multicentre investigator-initiated study

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: July 24, 2026
• Study Start: July 25, 2024
• Primary Completion: July 7, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

CH (1)