JAK Inhibitors for Solid Malignant Tumor Patients With Refractory Immune Checkpoint Inhibitors-related Dermatitis

Currently, the principal strategy for immune checkpoint inhibitors (ICI)-related dermatitis include systemic use of corticosteroids, which can impair the efficacy of preceding ICIs treatment. Janus kinase inhibitors (JAKi) could be the optimal option for ICI-related dermatitis, which can not only provide rapid relief for ICI-related dermatitis but also potentially enhance the anti-tumor efficacy of ICIs with minimal adverse events. This is an open-lable, phase II trial, aims to evaluate efficacy and safety of JAK inhibitors for solid malignant tumor patients with refractory ICI-related dermatitis.

Study Overview

• Status: Not yet recruiting
• Conditions: Immune Checkpoint Inhibitor-Induced Dermatitis
• Intervention / Treatment: Drug: treated with JAK inhibitors orally for 28 days

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shixiu Wu, MD; Phone Number: 08618983487900; Email: rainxl@foxmail.com

Study Locations

• China
  • Zhejiang
    • Quzhou, Zhejiang, China, 324000
      • Quzhou people's Hospital
      • Contact: Shixiu Wu, MD; Phone Number: +8618983487900; Email: rainxl@foxmail.com
      • Contact: Xinyu Liang, MD; Phone Number: +8619957098958; Email: 804169339@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must be at least 18 years of age
2. Clinical diagnosis of solid malignant tumor.
3. Patients who have received treatment with any Food and Drug Administration (FDA)-approved monoclonal antibodies targeting CTLA-4, PD-1, or PD-L1, either as monotherapy or in combination.
4. Clinical diagnosis of Immune checkpoint inhibitors (ICI)-related dermatitis graded as 3-4
5. Patients with ICI-related dermatitis who were refractory to previous treatment with corticosteroids and/or immunosuppressive agents.
6. Adequate bone marrow and organ function, as outlined below, must be confirmed:

1) White blood cell (WBC) count ≥ 2.0 × 10⁹/L 2) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L 3) Platelet count (PLT) ≥ 75 × 10⁹/L 4) Hemoglobin (Hgb) ≥ 90 g/L 5) AST and ALT ≤ 3 × upper limit of normal (ULN) in patients without hepatic metastases; ≤ 5 × ULN in those with hepatic metastases, provided the elevation is not attributable to ICI-related hepatitis 6) Total bilirubin ≤ 2 × ULN, except in cases of Gilbert's syndrome (where total bilirubin must be < 3.0 mg/dL), and not due to ICI-related hepatotoxicity 6. All participants must be capable of providing personally signed and dated informed consent, demonstrating understanding of all relevant study aspects.

Exclusion Criteria:

1. Clinical diagnosis of dermatological diseases (e.g., chronic inflammatory skin disorders such as atopic dermatitis or psoriasis) that, in the investigator's assessment, may elevate the risks associated with study participation or compromise the interpretation of study outcomes.
2. Female who is pregnant, breastfeeding, or considering pregnancy during the study.
3. Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
4. Patients with ICI-related dermatitis who were either treatment-naïve (having received no prior steroids or immunosuppressants)
5. Any other medical, psychiatric, or logistical condition that, in the judgment of the investigator, could pose a safety risk, affect protocol compliance, or interfere with the conduct or interpretability of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JAK inhibitors; treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days	Drug: treated with JAK inhibitors orally for 28 days; treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore the efficacy of JAK inhibitors in adult patients with refractory ICI-related dermatitis.	The efficacy evaluated by the proportion of patients with rashes relief (defined as ICI-related dermatitis grade ≤1according to CTCAE v5.0, )	At the end of treatment at day 28
Evaluate the safety of JAK inhibitors in adult patients with refractory ICI-related dermatitis	The safty will be assessed based on the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during upadacitinib treatment. The severity of AEs will be graded using NCI CTCAE v5.0.	During the period of medication（28 days） and follow-up（2 months after discontinuation of the drug）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of pruritus severity	Pruritus severity assessed by the time to achieve a 4-point improvement on the Peak Pruritus Numerical Rating Scale (PP-NRS)	From enrollment to the end of treatment at 28 days
Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment		At the end of treatment at day 28

Collaborators and Investigators

• Sponsor: Shixiu Wu

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: JAK inhibitors; refractory immune checkpoint inhibitors (ICI)-related dermatitis; Solid Malignant Tumor
• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: 2025-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes