SHR-1819 for moderate-to-severe atopic dermatitis in adults

A Multicenter, Randomized, Double-blind, Phase II Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis

This study tests an injectable drug called SHR-1819 to see if it improves symptoms and is safe for adults with moderate-to-severe atopic dermatitis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT07321951 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional trial of SHR-1819 given by injection to adults aged 18–75 with at least one year of atopic dermatitis and moderate-to-severe disease at screening. Participants must use stable topical emollients before and during the study and will receive either SHR-1819 injections or a blank comparator while being monitored. The trial will collect measures of skin response and record adverse events to characterize both efficacy signals and safety. Sites are sponsored by Guangdong Hengrui Pharmaceutical and are located in Guangzhou and Hangzhou, China.

Who should consider this trial

Good fit: Adults aged 18 to 75 with a documented history of atopic dermatitis for at least one year who currently have moderate-to-severe disease and can maintain stable topical emollient use are ideal candidates.

Not a fit: Patients with other active skin diseases or skin complications that might affect evaluation, those outside the 18–75 age range, or those with only mild atopic dermatitis are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, SHR-1819 could reduce symptoms and flare-ups and provide a new treatment option for adults with moderate-to-severe atopic dermatitis.

How similar studies have performed: Other injectable biologic therapies have demonstrated clear benefits in moderate-to-severe atopic dermatitis, but SHR-1819 itself remains early-stage and its effectiveness has not yet been proven.

Eligibility criteria

Inclusion Criteria:

1. At the time of signing the informed consent, the subjects are ≥18 years old and ≤75 years old, male or female.
2. The subjects have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.
3. Topical emollients are applied at a stable dose twice daily for at least 7 days before the first dose in the run-in phase and continued for the duration of the study.
4. Have atopic dermatitis at the time of screening and have an investigator-assessed history of atopic dermatitis for at least 1 year before screening.
5. Have moderate to severe atopic dermatitis during the screening period and on the day of the first dose.

Exclusion Criteria:

1. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
2. A history of spring keratoconjunctivitis and/or atopic keratoconjunctivitis within 6 months prior to screening.
3. Has malignancy or has a history of malignancy.
4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
5. Hypersensitivity to the study drug or any ingredient in the study drug.
6. Females who are pregnant or lactating.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Hangzhou Third People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Ran Li

Conditions Moderate-to-severe Atopic Dermatitis