Evaluating SHR-1819 injection for treating Prurigo Nodularis in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of SHR-1819 injection in adult patients diagnosed with Prurigo Nodularis. Participants will be randomly assigned to receive either the SHR-1819 injection or a placebo, allowing for a comparison of treatment effects. The study will involve monitoring participants for improvements in their condition and any potential side effects associated with the treatment. The trial is designed to gather data that could inform future treatment options for this chronic skin condition.

Why it matters

Who can join: the full rules

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. Has prurigo nodularis at screening.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
3. Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN.
4. PN secondary to medical conditions such as neurological or psychiatric disorders.
5. Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
6. 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.
7. Phase II: Treated with biologics targeting IL-4Rα, or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection. Phase III: Subjects who have previously received anti-IL-4Rα biologics for any indication including atopic dermatitis (AD), asthma, sinusitis, etc., and were judged by the investigator to have an inadequate response or intolerance (e.g., experienced drug-related adverse reactions requiring treatment discontinuation) must be excluded even if the washout requirement is met.
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. Major surgeries are planned for the duration of the study.
10. Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Huiliu Wang
• Email: huiliu.wang.hw330@hengrui.com
• Phone: +86-0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using nemolizumab (Nemluvio) to treat moderate-to-severe prurigo nodularis in adults

  This project tries nemolizumab (Nemluvio) in adults with moderate-to-severe prurigo nodularis to see if it reduces itching and symptoms by six months.

  Recruiting at 49 sites Galderma R&D · Birmingham, Alabama and 50 other locations · NCT06988618

• Evaluating MG-K10 injection for treating prurigo nodularis

  This study is testing a new injection to see if it can help adults with prurigo nodularis feel better by reducing their symptoms.

  Recruiting Phase 3 Shanghai Mabgeek Biotech.Co.Ltd · Beijing, Bejing · NCT06779136

• Investigating Dupilumab for Children with Prurigo Nodularis

  This study is testing if Dupilumab can help children with prurigo nodularis feel better and stay safe while using the medication.

  Recruiting at 15 sites Phase 3 Sanofi · Palo Alto, California and 14 other locations · NCT06293053

• Understanding the factors influencing chronic inflammatory skin diseases

  This study is trying to understand what causes different types of chronic skin conditions, like eczema and psoriasis, to behave differently in patients over time.

  Recruiting University Hospital Schleswig-Holstein · Kiel · NCT05928169

• Improving diagnosis and treatment for type 2 inflammatory skin diseases

  This study is trying to improve how we diagnose and treat type 2 inflammatory skin diseases like atopic dermatitis by creating a specialized center and looking at different treatment methods to see what works best.

  Recruiting Peking University First Hospital · Beijing · NCT05316805

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.