Status:
RECRUITING
Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Prurigo Nodularis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.
Eligibility Criteria
Inclusion
- 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.
- The age was ≥18 at the time of signing the informed consent and gender is unlimited.
- Have prurigo Nodularis at screening.
Exclusion
- Pregnant or lactating women.
- Major surgeries are planned for the duration of the study.
- 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.
- 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.
- Treated with biologics targeting IL-4Rα (such as dupliumab), or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection.
- Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
- Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
- 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).
- Use of other biologics (such as omalizumab) within 3 months or 5 half-lives prior to screening, whichever is longer as confirmation.
- Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.
Key Trial Info
Start Date :
September 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2026
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT06554509
Start Date
September 19 2024
End Date
August 20 2026
Last Update
October 10 2024
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100032