Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis

Launched by GUANGDONG HENGRUI PHARMACEUTICAL CO., LTD · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-1819 injection for adults with a condition known as Prurigo Nodularis, which causes itchy, raised bumps on the skin. The main goal of the study is to see how effective this treatment is and whether it is safe for patients. The trial is currently looking for participants aged 18 and older who have been diagnosed with Prurigo Nodularis and are willing to follow the study guidelines.

If you or someone you know is interested in joining, it's important to know that certain people may not qualify. For example, pregnant or breastfeeding women cannot participate, nor can those with certain serious health issues or other skin diseases that could interfere with the study. Participants will receive the SHR-1819 injection and will be monitored closely for any effects or side effects. This study hopes to provide more options for those suffering from Prurigo Nodularis and improve their quality of life.

Gender

ALL

Eligibility criteria

• 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. Have prurigo Nodularis at screening.
• Exclusion Criteria:
• • 1. Pregnant or lactating women.
• • 2. Major surgeries are planned for the duration of the study.
• • 3. Has an active skin disease (such as chronic lichen simplex, psoriasis, chronic photosensitive dermatitis, etc.) or skin complications due to other diseases that may affect the evaluation of PN.
• • 4. 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.
• • 5. Treated with biologics targeting IL-4Rα (such as dupliumab), or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection.
• • 6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
• • 7. Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
• • 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. Use of other biologics (such as omalizumab) within 3 months or 5 half-lives prior to screening, whichever is longer as confirmation.
• • 10. Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.