Clinical trial NCT06554509: Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Prurigo Nodularis
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1819 compared with placebo
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Phase II: Proportion of subjects with a ≥4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 16
timeFrame: up to 16 weeks
measure: Phase III: Proportion of subjects with a ≥4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 24
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Phase II: Weekly mean change from baseline and percentage change in weeks 2, 4, 8, 12, and 16 of WI-NRS
timeFrame: up to 16 weeks
measure: Phase II: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12 and 16
timeFrame: up to 16 weeks
measure: Phase II: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16
timeFrame: up to 16 weeks
measure: Phase III: Proportion of subjects with an IGA CNPG-S score of 0/1 at week 24
timeFrame: up to 24 weeks
measure: Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12, 16, and 20
timeFrame: up to 24 weeks
measure: Phase III: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16, 20, 24
timeFrame: up to 24 weeks
measure: Phase II/III: The concentration of SHR-1819 in serum: AUC
timeFrame: From the beginning of administration to the 24/32th week
measure: Phase II/III: Changes in the level of IgE in the serum
timeFrame: From the beginning of administration to the 24/32th week
measure: Phase II/III: Immunogenic endpoint: evaluate the incidence of ADA positivity for SHR-1819
timeFrame: From the beginning of administration to the 24/32th week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: