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

Phase 2

Recruiting

• Conditions: Immune Checkpoint Inhibitors (ICI)-Related Dermatitis
• Interventions: Drug: JAK Inhibitor

• Registration Number: NCT06715982
• Lead Sponsor: Shixiu Wu

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-22
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-28
• Study First Posted: 2024-12-04
• Study Start: 2024-12-31
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-09
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JAK inhibitors	JAK Inhibitor	treated with JAK inhibitors orally for 28 days

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Quzhou people's hospital; 🇨🇳 Quzhou, Zhejiang, China