Immune Checkpoint Inhibitors (ICI)-Related DermatitisPhase 2NCT06715982
JAK Inhibitors for Solid Malignant Tumor Patients With Immune Checkpoint Inhibitors-related Dermatitis: A Open-lable, Single Arm, Phase IIa Trial
A Phase 2 study testing JAK Inhibitor in people with Immune Checkpoint Inhibitors (ICI)-Related 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 to 80 years
- Conditions the study is for
- Immune Checkpoint Inhibitors (ICI)-Related Dermatitis
- What is being tested?
- JAK Inhibitor
- 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
- 31 Dec 2024to Dec 2025
- Phase
- Phase 2
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must be at least 18 years of age with a confirmed diagnosis of a 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.
- 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.
- 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.
- 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
- 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.
- Patients who currently present with persistent dermatitis (grade >1, according to CTCAE v5.0) attributable to therapeutic interventions other than ICIs treatment.
- 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.
- 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, 1 recruiting
- Recruiting
Quzhou people's hospital
Quzhou, Zhejiang, 324000
Lijun Lou, +86-0570-3121509, qzryjgb@126.com
About this study
Official title: 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.
- Being tested
- JAK Inhibitor
- Keywords
- immune checkpoint inhibitors (ICI)-related dermatitis, Janus kinase inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAK InhibitorDrug
JAK inhibitors for 28 days
| Study group | Role | What they receive |
|---|---|---|
| JAK inhibitors | Experimental | treated with JAK inhibitors orally for 28 days Receives: Drug: JAK Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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, )
Measured: at baseline, 7, 14 ,21and 28 days
Secondary outcomes (2)
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.
Measured: at baseline, 7, 14 ,21and 28 days.
Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start31 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint Inhibitors (ICI)-Related 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
- NCT06715982
- Sponsor's protocol ID
- HangzhouCH51
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2024
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes