New drug may tame immunotherapy skin rash without steroids
NCT ID NCT06715982
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests whether JAK inhibitors can safely and effectively treat severe skin rashes caused by immune checkpoint inhibitors in cancer patients. The goal is to relieve symptoms without using steroids, which can weaken the anti-cancer effect of immunotherapy. The study will enroll 35 adults with solid tumors who have developed grade 3-4 dermatitis from their cancer treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JAK inhibitor (upadacitinib)
- What this could lead to
- If it works, this could offer a steroid-free way to manage severe skin rashes caused by immunotherapy, potentially allowing patients to continue cancer treatment.
- What could go wrong
- This is a small, early-phase trial with only 35 participants and no comparison group, so results may not apply broadly. JAK inhibitors also carry risks like infection and blood clots.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Quzhou people's hospital
RECRUITINGQuzhou, Zhejiang, 324000, China
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Other studies related to the condition(s) this trial covers.
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