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Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities

Study acronym: TRUX-LST
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 20 to confirmed 22 · Primary completion date changed from estimate of Mar 2026 to Apr 22, 2026 · Site details revisedv4 Show 3 more changesShow less
    • Enrollment target: estimated 20 to confirmed 22
    • Primary completion date changed from estimate of Mar 2026 to Apr 22, 2026
    • Site details revised
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2024 to Oct 10, 2024 · Study sites: 0 to 1 · Primary completion date: Nov 2025 to Mar 2026 · 2 morev3 Show 5 more changesShow less
    • Start date changed from estimate of Jun 2024 to Oct 10, 2024
    • Study sites: 0 to 1
    • Primary completion date: Nov 2025 to Mar 2026
    • Completion date: Dec 2025 to May 2026
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Start date: May 2024 to Jun 2024v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06399029
Lead Sponsor University of Zurich
Collaborators: Incyte Corporation
Conditions Exanthema, Lichenoid Skin Rashes Under Anti-PD1 Tumor Therapy
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov