Immune Checkpoint Inhibitor-Induced DermatitisPhase 2NCT07530224
JAK Inhibitors for Solid Malignant Tumor Patients With Refractory Immune Checkpoint Inhibitors-related Dermatitis
A Phase 2 study testing treated with JAK inhibitors orally for 28 days in people with Immune Checkpoint Inhibitor-Induced Dermatitis, run by Shixiu Wu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Checkpoint Inhibitor-Induced Dermatitis
- What is being tested?
- treated with JAK inhibitors orally for 28 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2026to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Quzhou people's hospital
Quzhou, Zhejiang, 324000
Shixiu Wu, MD, +8618983487900, rainxl@foxmail.com
Xinyu Liang, MD, +8619957098958, 804169339@qq.com
About this study
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.
- Being tested
- treated with JAK inhibitors orally for 28 days
- Keywords
- refractory immune checkpoint inhibitors (ICI)-related dermatitis, Solid Malignant Tumor, JAK inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treated with JAK inhibitors orally for 28 daysDrug
treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days
| Study group | Role | What they receive |
|---|---|---|
| JAK inhibitors | Experimental | treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days Receives: Drug: treated with JAK inhibitors orally for 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, )
Measured: 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.
Measured: 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
Pruritus severity assessed by the time to achieve a 4-point improvement on the Peak Pruritus Numerical Rating Scale (PP-NRS)
Measured: From enrollment to the end of treatment at 28 days
Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment
Measured: At the end of treatment at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start25 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint Inhibitor-Induced DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shixiu Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shixiu Wu, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530224
- Sponsor's protocol ID
- 2025-105
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JAK Inhibitors for Solid Malignant Tumor Patients With Refractory Immune Checkpoint Inhibitors-related Dermatitis
- ClinicalTrials.gov ID
- NCT07530224
- Acronym / sponsor ID
- 2025-105
- Keywords
- refractory immune checkpoint inhibitors (ICI)-related dermatitis, Solid Malignant Tumor, JAK inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shixiu WuUniversity, hospital or other
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JAK inhibitors | Experimental | Drug: treated with JAK inhibitors orally for 28 daystreated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treated with JAK inhibitors orally for 28 daystreated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days | Drug | JAK inhibitors |
Primary outcome
Explore the efficacy of JAK inhibitors in adult patients with refractory ICI-related dermatitis.
Time frame: At the end of treatment at day 28
The efficacy evaluated by the proportion of patients with rashes relief (defined as ICI-related dermatitis grade ≤1according to CTCAE v5.0, )
Evaluate the safety of JAK inhibitors in adult patients with refractory ICI-related dermatitis
Time frame: During the period of medication（28 days） and follow-up（2 months after discontinuation of the drug）
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.
2 secondary outcomes
The change of pruritus severity
Time frame: From enrollment to the end of treatment at 28 days
Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment
Time frame: At the end of treatment at day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing treated with JAK inhibitors orally for 28 days in people with Immune Checkpoint Inhibitor-Induced Dermatitis, run by Shixiu Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shixiu Wu, MD (08618983487900, rainxl@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the efficacy of JAK inhibitors in adult patients with refractory ICI-related dermatitis. (time frame: At the end of treatment at day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.