What is SHR-1819 studying for Prurigo Nodularis?

SHR-1819 is being studied to evaluate its safety and how well it reduces itching and skin symptoms in adults with Prurigo Nodularis. This randomized trial compares different doses of SHR-1819 against a placebo to better understand its effects. The research is sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd and aims to improve treatment options for this condition.

Who may be eligible for this Prurigo Nodularis clinical trial?

Adults aged 18 and older with a diagnosis of Prurigo Nodularis may be eligible for this trial. Both men and women can participate, but pregnant or breastfeeding women are excluded. People with certain other skin conditions, recent substance abuse, or specific medical histories may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this Prurigo Nodularis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for their own travel arrangements accordingly.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID06554509

Study of SHR-1819 Injection to Treat Adults With Prurigo Nodularis Randomized, Double-blind, Placebo-controlled Phase 23 Trial

Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2026-04-29

423

Participants Needed

Research Sites

N/A

Total Duration

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 drugs 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

Age: 18Years +

All Genders

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.

Research Team

Huiliu Wang

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