Actively Recruiting
Multicenter Randomized Double-blind Placebo-controlled Study of SHR-1819 Injection for Adults With Prurigo Nodularis
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2026-04-29
423
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of SHR-1819 injection in adults with Prurigo Nodularis, a skin condition characterized by itchy nodules. This multicenter trial is designed as a randomized, double-blind, placebo-controlled study combining Phase II and Phase III stages to assess the treatment effects over several weeks. The study aims to measure improvements in itch intensity and skin condition as primary outcomes, with additional focus on quality of life and immune response markers. Participants will be assigned randomly to receive either different doses of SHR-1819 injection or a placebo injection. The Phase II portion evaluates outcomes up to 16 weeks, while Phase III extends assessments up to 24 weeks and beyond. The study also monitors serum drug concentration, IgE levels, and immunogenicity to better understand the drug's behavior and patient response. During the study, participants will undergo regular evaluations including pruritus intensity scales, Investigator Global Assessment scores, and quality of life questionnaires. Blood samples will be taken to measure drug levels and immune markers. Safety and response data will be collected throughout the treatment period and follow-up visits, which may last up to 52 weeks, ensuring thorough monitoring of both efficacy and potential side effects.
CONDITIONS
Brief Title
Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily sign informed consent and can communicate and comply with study requirements.
- Age 18 years or older at time of consent; all genders allowed.
- Diagnosed with Prurigo Nodularis at screening.
You will not qualify if you...
- Pregnant or lactating women.
- History of heavy alcohol use or substance abuse within 6 months prior to screening.
- Active skin diseases or complications that could affect Prurigo Nodularis evaluation.
- Prurigo Nodularis secondary to neurological or psychiatric disorders.
- Diagnosis of moderate to severe atopic dermatitis during screening or prior to randomization.
- Clinically significant diseases that may pose safety risks or affect study results.
- Previous treatment with or intolerance to biologics targeting IL-4Rα (Phase II and III specific).
- History of malignancy prior to screening, except certain fully resected skin or cervical cancers.
- Planned major surgeries during the study period.
- Other conditions deemed unsuitable for participation by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 or 24 weeks depending on phase
Participants receive SHR-1819 injection or placebo to evaluate efficacy and safety in treating Prurigo Nodularis.
Weekly visits for up to 24 weeks
Duration - Up to 52 weeks
Participants are monitored for safety and long-term effects after treatment completion.
Visits at study follow-up timepoints up to 52 weeks
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
H
Huiliu Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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