New shot aims to stop the maddening itch of prurigo nodularis
NCT ID NCT06554509
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an injection called SHR-1819 to see if it can safely reduce the intense itching caused by prurigo nodularis, a chronic skin condition with hard, itchy bumps. About 423 adults will receive either the drug or a placebo, and researchers will track how much their worst itch improves over 16 to 24 weeks. The goal is to find a new treatment option for people who suffer from this distressing itch.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 423 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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. Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol. 2. The age was ≥18 at the time of signing the informed consent and gender is unlimited. 3. Has prurigo nodularis at screening. Exclusion Criteria: 1. Pregnant or lactating women. 2. Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening. 3. Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN. 4. PN secondary to medical conditions such as neurological or psychiatric disorders. 5. Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization. 6. History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis. 7. Phase II: Treated with biologics targeting IL-4Rα, or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection. Phase III: Subjects who have previously received anti-IL-4Rα biologics for any indication including atopic dermatitis (AD), asthma, sinusitis, etc., and were judged by the investigator to have an inadequate response or intolerance (e.g., experienced drug-related adverse reactions requiring treatment discontinuation) must be excluded even if the washout requirement is met. 8. Subjects with malignancy prior to screening (except for squamous cell carcinoma of the skin, basal cell carcinoma, or carcinoma in situ of the cervix that are completely resected and have no evidence of recurrence). 9. Major surgeries are planned for the duration of the study. 10. Other conditions that, in the opinion of the investigator, are not suitable for participation in this 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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Peking University People's Hospital
RECRUITINGBeijing, Beijing Municipality, 100032, China
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Other studies related to the condition(s) this trial covers.
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- New drug aimed at calming the itch of prurigo nodularis enters human testing
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