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NCT Number: NCT06399029

Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities

Skin rash during tumor treatment with immunotherapy (anti-PD1 antibody therapy) is a common side effect. If patients suffer from such a skin reaction, they typically suffer from a rash on the chest, back and extremities. The skin reaction is usually treated with cortisone in cream or tablet form. There is already research in humans on the skin reaction under anti-PD1 antibody therapy. Previous studies in humans have shown that certain inflammatory markers are elevated. It is also know that the study drug can help to reduce these inflammatory markers. However, there is currently not enough data available whether the study drug can actually reduce inflammation in the skin in a rash under anti-PD1 antibody therapy. The investigators are therefore examining in this study whether the study drug is effective and well tolerated in a skin rash under anti-PD1 antibody therapy. The study drug contains the active ingredient ruxolitinib and is applied as a cream. The study drug is approved for other skin diseases (vitiligo and atopic eczema) in the USA and in countries of the European Union (EU). Approval in Switzerland is still pending. Only once the efficacy of the study drug against skin rashes under anti-PD1 antibody therapy has been scientifically investigated and proven can it be approved and used as a therapy in Switzerland. In this study, the participants are not divided into groups. Each study patient receives the test substance.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Exanthema Lichenoid Skin Rashes Under Anti-PD1 Tumor Therapy Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University hospital Zürich, Department Dermatology

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Indication: lichenoid skin toxicities / rash which has developed under / after anti-PD-1 therapy.
  • Male and Female patients ≥18 years of age
  • Patients that are able to speak and read German or English.
  • The subject was informed and gave his/her consent to the Institutional Review Boards (IRB)/Independent Ethics Committee (IEC) -approved informed consent

Exclusion criteria

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

  • Patient suffering other skin disease resembling lichenoid skin lesions under anti-PD-1 therapy.
  • Acute psychiatric illness or acute crisis.
  • Contraindications to ruxolitinib, e.g. known hypersensitivity or allergy
  • Topical glucocorticosteroids, topical calcineurin inhibitors and UV light therapy are not allowed during the study or for 1 week before the study beginning. Other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine are not allowed during the study or for 8 weeks before the study beginning.
  • 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 study with topical or oral ruxolitinib within the 30 days preceding and during the present study.
  • Previous enrolment into the current study.
  • Enrolment of the investigator, his/her family members, employees and other dependent persons.
  • Participants must avoid pregnancy during the study. A blood pregnancy test is required before start of therapy, with regular urine tests throughout. Lactating individuals are ineligible.

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.

Treatment and study plan

Ruxolitinib Topical Cream

Drug

Ruxolitinib cream will be applied topically twice daily on up to 20% of the body surface over 12 weeks in patients with lichenoid skin toxicity under anti PD1 treatment.

Other names: Topical Ruxolitinib (INCB18424)

Primary outcomes

  1. Proportion of patients achieving at least 90% improvement of rash at week 12.

    Time frame: week 12

    The improvement of rash is defined on the physician global assessment score (PGA) and on the body surface area (BSA).

    PGA: measures the overall response to treatment as assessed by the physician; scale 0-4

    Reduction of PGA (e.g. PGA 4 to PGA0) will be converted into percentage: decrease of PGA of 1 point on a scale from 0 to 4 shows a decrease of 25%, decrease of 4 points shows a decrease of 100%.

    This value (percentage of PGA decrease) will be combined with the reduction of BSA (percentage) and will result in the improvement of rash.

Secondary outcomes

  1. Proportion of patients achieving 75% improvement of rash at week 12.

    Time frame: week 12

    The improvement of rash is defined on the physician global assessment score (PGA) and on the body surface area (BSA).

    PGA: measures the overall response to treatment as assessed by the physician; scale 0-4

    Reduction of PGA (e.g. PGA 4 to PGA0) will be converted into percentage: decrease of PGA of 1 point on a scale from 0 to 4 shows a decrease of 25%, decrease of 4 points shows a decrease of 100%.

    This value (percentage of PGA decrease) will be combined with the reduction of BSA (percentage) and will result in the improvement of rash.

  2. Proportion of patients achieving 50% improvement of rash at week 12.

    Time frame: week 12

    The improvement of rash is defined on the physician global assessment score (PGA) and on the body surface area (BSA).

    PGA: measures the overall response to treatment as assessed by the physician; scale 0-4

    Reduction of PGA (e.g. PGA 4 to PGA0) will be converted into percentage: decrease of PGA of 1 point on a scale from 0 to 4 shows a decrease of 25%, decrease of 4 points shows a decrease of 100%.

    This value (percentage of PGA decrease) will be combined with the reduction of BSA (percentage) and will result in the improvement of rash.

  3. Percentage change from body surface area at baseline to week 2, 4, 8 and 12

    Time frame: baseline, week 2, 4, 8 and 12

    Calculation of the affected body surface area as a percentage.

  4. Proportion of patient reported outcome: Itch Numerical Rating Scale (Itch NRS)

    Time frame: baseline, week 2, 4, 8 and 12

    Itch Numerical Rating Scale (Itch NRS): 2 questions, rating the itch intensity on a scale from 0 to 10 points

  5. Proportion of patient reported outcome: Dermatology Life Quality Index (DLQI)

    Time frame: baseline, week 2, 4, 8 and 12

    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

  6. Proportion of patient reported outcome: Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: baseline, week 2, 4, 8 and 12

    Treatment Satisfaction Questionnaire for Medication (TSQM): The TSQM is a questionnaire used to measure patient satisfaction with medication. The score ranges from 0 to 100 points

  7. Proportion of patient reported outcome: Five Well-Being Index (WHO-5)

    Time frame: baseline, week 2, 4, 8 and 12

    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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Incyte Corporation

Registry information

Official study title

Topical Ruxolitinib as a Treatment of Anti-PD1 Induced Lichenoid Skin Toxicities: a Prospective Single-center Pilot Study

Acronym: TRUX-LST

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 3, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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