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Topical Ruxolitinib Evaluation in Immune-related Vitiligo-like Depigmentation (TRuE-VLD)

20. Juli 2026 aktualisiert von: Lara Maul-Duwendag, University of Zurich

Topical Ruxolitinib for the Treatment of Immune-related Vitiligo-like Depigmentation: A Prospective, Multicentre Study of a Topical JAK-inhibitor

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

34

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Schweiz
      • Zurich, Schweiz, 8058
        • Universitätsspital Zürich

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

Adult patients eligible for this inclusion in this study have to fulfil all the following criteria:

  • 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

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for the inclusion in this study:

  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Topical ruxolitinib
This study will be performed as one-arm with no comparator.
Arzneimittel: Ruxolitinib Topical Cream
Ruxolitinib cream 1.5% will be applied topically twice daily over 52 weeks in patients with immune-related vitiligo-like depigmentation.
Andere Namen:
  • Topical Ruxolitinib (OPZELURA)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients achieving a Facial vitiligo scoring index of 75% (F-VASI75) at week 24
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients achieving a F-VASI of 25%, 50% and 90% (F-VASI25/50/90)
Zeitfenster: week 24 and 52
The F-VASI assesses the percentage of repigmentation on the face. Achieving an F-VASI of 50% means that a 50% improvement in facial repigmentation has been achieved. The same applies to an F-VASI of 25% or 90%; this corresponds to 25% respectively 90% repigmentation. 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 and 52
Proportion of patients achieving a F-VASI 75 only at week 52
Zeitfenster: week 52
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. 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 52
Proportion of patients achieving a Total Vitiligo Area Scoring Index of 25%, 50%, 75% and 90% (T-VASI25/50/75/90)
Zeitfenster: week 24 and 52
T-VASI is a measure used to evaluate the success of vitiligo treatment over the entire body. A T-VASI of for instance 75% means that a 75% improvement in repigmentation of the entire skin of the body has been achieved. The T-VASI is calculated by estimating and weighting the area of depigmented skin and the degree of repigmentation. Percentage of depigmentation (0% = no depigmentation present, 100% = completely depigmented skin) is multiplied by the affected body surface area in percent. The unit of "Proportion of patients achieving a Total Vitiligo Area Scoring Index of 25%, 50%, 75% and 90% (T-VASI25/50/75/90)" is a percentage. It is looked at what percentage of participants have achieved an improvement in their T-VASI score. It is looked at how many participants have achieved a 25% improvement, how many a 50% improvement, how many a 75% improvement and how many a 90% improvement in their T-VASI score.
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)
Zeitfenster: week 24 and 52
The VNS is an assessment tool developed to measure the visibility, conspicuousness and appearance of vitiligo spots. The score has a scale from one to five. One means more noticeable, five means no noticeability/visibility.
week 24 and 52
Percentage change from baseline in the Facial Body Surface Area (F-BSA) and Total Body Surface Area (T-BSA)
Zeitfenster: week 24 and 52
Calculation of the affected body surface area as a percentage. Once the affected surface on the face and once the affected surface on the entire integument.
week 24 and 52
Percentage change from baseline in the Facial Physician's Global Vitiligo Assessment (F-PhGVA) and Total Physician's Global Vitiligo Assessment (T-PhGVA)
Zeitfenster: week 24 and 52

The F-PhGVA is an assessment tool used by physicians to evaluate the severity of facial vitiligo. It is based on a global assessment by the treating physician and takes into account various aspects of the disease, including the area and extent of depigmentation as well as the aesthetic impairment. The assessment is made on a numerical scale, categorizing different degrees of severity of facial vitiligo. The scale ranges from 0 to 4, with 0 corresponding to skin with no signs of vitiligo/complete repigmentation and 4 corresponding to very severe vitiligo.

The T-PhGVA is a global assessment of the disease across the entire body. It has the same numerical scale as the F-PhGVA, ranging from 0 to 4, with 0 corresponding to skin with no signs of vitiligo/complete repigmentation and 4 corresponding to very severe vitiligo.

Both scores are useful tools for evaluating the success of treatment for vitiligo on the face and the entire body and for documenting the progress of patients.
week 24 and 52
Change in disease stability
Zeitfenster: week 24 and 52
The change of disease stability is defined as an exclusion of progressive vitiligo over a 1-year period with no increase in size of existing vitiligo foci, no new vitiligo foci, no Koebner phenomenon
week 24 and 52
Proportion of patient reported outcome: Dermatology Life Quality Index (DLQI)
Zeitfenster: baseline, week 24 and 52
Dermatology Life Quality Index (DLQI): 10 questions, summing the score of each question resulting in a minimum of 0 and a maximum of 30 points
baseline, week 24 and 52
Proportion of patient reported outcome: Treatment Satisfaction Questionnaire for Medication (TSQM)
Zeitfenster: baseline, week 24 and 52
Treatment Satisfaction Questionnaire for Medication (TSQM): questionnaire used to measure patient satisfaction with medication. The score ranges from 0 to 100 points
baseline, week 24 and 52
Proportion of patient reported outcome: Vitiligo Noticeability Scale (VNS)
Zeitfenster: baseline, week 24 and 52
Vitiligo Noticeability Scale (VNS): score with a scale from one to five. One means more noticeable, five means no noticeability/visibility.
baseline, week 24 and 52
Proportion of patient reported outcome: Color-matching questions
Zeitfenster: baseline, week 24 and 52
Color-matching questions: The patient assesses how well the color of the skin affected by VLD matches the surrounding, unaffected skin after treatment. Five answer options with a grading between "excellent" and "very poor" are possible.
baseline, week 24 and 52
Proportion of patient reported outcome: Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V)
Zeitfenster: baseline, week 24 and 52
Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V): Patients assess the change in VLD on their face since starting treatment with the drug. Seven answer options are possible with a grading of "very much improved" and "very much worse"
baseline, week 24 and 52
Proportion of patient reported outcome: Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V)
Zeitfenster: baseline, week 24 and 52
Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V): Patients assess the change of VLD on their total body since starting treatment with the drug. Seven answer options are possible with a grading of "very much improved" and "very much worse"
baseline, week 24 and 52
Proportion of patient reported outcome: Five Well-Being Index (WHO-5)
Zeitfenster: baseline, week 24 and 52
Five Well-Being Index (WHO-5): a short self-reported measure of current mental wellbeing. It consists of five statements, which respondents rate according to a scale between 0 to 5
baseline, week 24 and 52
Proportion of patient reported outcome: Hospital Anxiety and Depression Scale (HADS)
Zeitfenster: baseline, week 24 and 52
Hospital Anxiety and Depression Scale (HADS): is used to measure anxiety and depression in patients with physical illnesses. The severity of anxious and depressive symptoms during the past week is recorded by means of self-assessment on two subscales with seven items each. The total sum score can be used as a measure of general psychological impairment.
baseline, week 24 and 52
Proportion of patient reported outcome: Vitiligo Quality of Life Index (VitiQoL)
Zeitfenster: baseline, week 24 and 52
Vitiligo Quality of Life Index (VitiQoL): specially developed instrument to measure the quality of life of people with vitiligo. It captures the psychosocial and emotional impact of the disease on the daily lives of those affected. As vitiligo can have not only physical but also significant psychological and social effects, the VitiQoL is a valuable tool to assess these comprehensively. Contains 16 questions.
baseline, week 24 and 52
Proportion of patient reported outcome: load thermometer
Zeitfenster: baseline, week 24 and 52
The patient must indicate on a scale from zero to ten how much the VLD is bothering them. Grading from "not at all burdensome" to "extremely burdensome".
baseline, week 24 and 52

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Assessment of skin shave biopsies
Zeitfenster: Baseline and week 52
Differences in the cutaneous immune microenvironment in skin shave biopsies will be investigated using multi-omics technics. Histology, immune-histology, multiplex and single-cell RNA sequencing analyses will be performed.
Baseline and week 52

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Zurich

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

25. Juli 2024

Primärer Abschluss (Tatsächlich)

7. Juli 2026

Studienabschluss (Geschätzt)

31. August 2026

Studienanmeldedaten

Zuerst eingereicht

31. Mai 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Juli 2026

Zuerst gepostet (Tatsächlich)

24. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2023-01552

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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