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

Hengrui Medicine

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Prurigo Nodularis

Treatments: Drug: Placebo; Drug: SHR-1819 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06554509

SHR-1819-302

Details and patient eligibility

About

This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.

Enrollment: 236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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236 participants in 4 patient groups, including a placebo group

Treatment group A：SHR-1819 injection dose 1

Experimental group

Treatment:

Drug: SHR-1819 injection

Treatment group B：SHR-1819 injection dose 2

Experimental group

Treatment:

Drug: SHR-1819 injection

Treatment group C：SHR-1819 injection dose 3

Experimental group

Treatment:

Drug: SHR-1819 injection

Treatment group D：placebo

Placebo Comparator group

Treatment:

Drug: Placebo