New drug combo may tame immunotherapy skin rash without hurting cancer fight
NCT ID NCT07530224
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial tests JAK inhibitors (upadacitinib or tofacitinib) in 35 adults with solid tumors who have severe skin rashes from immunotherapy that didn't improve with steroids. The goal is to see if these pills can quickly relieve the rash and itching while allowing patients to keep receiving their cancer treatment. The study will also monitor side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JAK inhibitors (upadacitinib or tofacitinib)
- What this could lead to
- If it works, this could offer a new way to treat severe skin rashes caused by immunotherapy, allowing patients to continue their cancer treatment without needing steroids.
- What could go wrong
- This is a small, early-phase trial with only 35 participants, so results may not apply to everyone. JAK inhibitors also have risks like infection or 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.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
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 years and older
- 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. Must be at least 18 years of age 2. Clinical diagnosis of solid malignant tumor. 3. 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. 4. Clinical diagnosis of Immune checkpoint inhibitors (ICI)-related dermatitis graded as 3-4 5. Patients with ICI-related dermatitis who were refractory to previous treatment with corticosteroids and/or immunosuppressive agents. 6. 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. 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. 2. Female who is pregnant, breastfeeding, or considering pregnancy during the study. 3. 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. 4. Patients with ICI-related dermatitis who were either treatment-naïve (having received no prior steroids or immunosuppressants) 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
Quzhou, Zhejiang, 324000, China
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