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

NCT07530224 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025-105
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immune Checkpoint Inhibitor-Induced Dermatitis

Keywords

refractory immune checkpoint inhibitors (ICI)-related dermatitis; Solid Malignant Tumor; JAK inhibitors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The change of pruritus severity

  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

Study Arms (1)

JAK inhibitors

EXPERIMENTAL

treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days

Drug: treated with JAK inhibitors orally for 28 days

Interventions

treated with JAK inhibitors orally for 28 days DRUG

treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days

JAK inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age
• Clinical diagnosis of solid malignant tumor.
• 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.
• Clinical diagnosis of Immune checkpoint inhibitors (ICI)-related dermatitis graded as 3-4
• Patients with ICI-related dermatitis who were refractory to previous treatment with corticosteroids and/or immunosuppressive agents.
• Adequate bone marrow and organ function, as outlined below, must be confirmed:
• \) 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.

You may not qualify if:

• 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.
• Female who is pregnant, breastfeeding, or considering pregnancy during the study.
• 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.
• Patients with ICI-related dermatitis who were either treatment-naïve (having received no prior steroids or immunosuppressants)
• 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.

Sponsors & Collaborators

• Shixiu Wu: lead

Study Sites (1)

Quzhou people's hospital

Quzhou, Zhejiang, 324000, China

Location

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

Shixiu Wu, MD

CONTACT

08618983487900; rainxl@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 15, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)