JAK Inhibitors for Solid Malignant Tumor Patients With Immune Checkpoint Inhibitors-related Dermatitis: A Open-lable, Single Arm, Phase IIa Trial

JAK Inhibitors for Solid Malignant Tumor Patients With Immune Checkpoint Inhibitors-related Dermatitis: A Open-lable, Single Arm, Phase II Trial

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. This is an open-lable, single arm, phase II trial, aims to evaluate efficacy and safety of JAK inhibitors for solid malignant tumor patients with ICI-related dermatitis.

Study Overview

• Status: Recruiting
• Conditions: Immune Checkpoint Inhibitors (ICI)-Related Dermatitis
• Intervention / Treatment: Drug: JAK Inhibitor

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

Contacts and Locations

• Study Contact: Name: Shixiu Wu; Phone Number: +86-18983487900; Email: wushixiu@medmail.com.cn

Study Locations

• China
  • Zhejiang
    • Quzhou, Zhejiang, China, 324000
      • Recruiting
      • Quzhou people's Hospital
      • Contact: Lijun Lou; Phone Number: +86-0570-3121509; Email: qzryjgb@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria:

1. Eligible patients must be at least 18 years of age with a confirmed diagnosis of a solid malignant tumor.
2. 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.
3. Patients who are diagnosed with Immune checkpoint inhibitors (ICI)-related dermatitis graded as 3-4 according to Common Terminology Criteria for Adverse Events Version 5.0.
4. Patients with ICI-related dermatitis who were either treatment-naïve (having received no prior steroids or immunosuppressants) or were refractory to previous treatment with corticosteroids and/or immunosuppressive agents.
5. 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. Patients with 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. Patients who currently present with persistent dermatitis (grade >1, according to CTCAE v5.0) attributable to therapeutic interventions other than ICIs treatment.
3. Female who is pregnant, breastfeeding, or considering pregnancy during the study.
4. 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.
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 orally for 28 days	Drug: JAK Inhibitor; JAK inhibitors for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety of JAK inhibitors in adult patients with 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.	at any time
Explore the efficacy of JAK inhibitors in adult patients with ICI-related dermatitis.	The efficacy evaluated by the proportion of patients achieving relief from rashes (defined as ICI-related dermatitis grade ≤1according to CTCAE v5.0, )	at baseline, 7, 14 ,21and 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of pruritus severity	Pruritus severity assessed by Peak Pruritus Numerical Rating Scale (PP-NRS), score 0-10, a higher score indicates a more severe pruritus condition.	at baseline, 7, 14 ,21and 28 days.
Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment		at 28 days

Collaborators and Investigators

• Sponsor: Shixiu Wu

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 26, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Janus kinase inhibitors; immune checkpoint inhibitors (ICI)-related dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Pharmacologic Actions; Chemical Actions and Uses; Janus Kinase Inhibitors
• Other Study ID Numbers: HangzhouCH51

Plan for Individual participant data (IPD)

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

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