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Tests treatment safety and results for Prurigo Nodularis
Official title Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
ClinicalTrials.gov ID: NCT06554509
What this study is testing
What is SHR-1819 Injection?
SHR-1819 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prurigo nodularis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly...
- The age was ≥18 at the time of signing the informed consent and gender is unlimited.
- Has prurigo nodularis at screening.
You likely can't join if
- Pregnant or lactating women.
- Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
- Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN.
- PN secondary to medical conditions such as neurological or psychiatric disorders.
- Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
- History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders...
See the full eligibility criteria
- people 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...
- The age was ≥18 at the time of signing the informed consent and gender is unlimited.
- Has prurigo nodularis at screening.
- Pregnant or lactating women.
- Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
- Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN.
- PN secondary to medical conditions such as neurological or psychiatric disorders.
- Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
- History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and...
- 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: people who have previously received anti-IL-4Rα...
- people 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).
- Major surgeries are planned for the duration of the study.
- Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.