SHR-1905 treatment for moderate-to-severe atopic dermatitis

A Randomized, Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of SHR-1905 Injection in Patients With Moderate to Severe Atopic Dermatitis

This trial will test whether SHR-1905 injections help adults aged 18–75 who have moderate-to-severe atopic dermatitis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07211542 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives adults with moderate-to-severe atopic dermatitis injections of SHR-1905 or a blank preparation and monitors response and side effects. Participants must be 18–75 years old, able to consent, and meet inclusion/exclusion criteria. The primary focus is on clinical skin outcomes and safety measured during the treatment period at a single site in Guangzhou, China. Investigators will compare symptom improvement and adverse events between the SHR-1905 and blank-preparation groups.

Who should consider this trial

Good fit: Adults 18–75 with moderate-to-severe atopic dermatitis who can communicate with investigators, give informed consent, and comply with study procedures are ideal candidates.

Not a fit: Patients who are pregnant or lactating, have hypersensitivity to the study drug, other active skin diseases that confound assessment, a history of malignancy, or serious uncontrolled comorbidities may not benefit or be eligible.

Why it matters

Potential benefit: If successful, SHR-1905 could reduce inflammation and improve skin clearance and quality of life for people with moderate-to-severe atopic dermatitis.

How similar studies have performed: Other biologic and systemic therapies have shown benefit in moderate-to-severe atopic dermatitis, but SHR-1905 is an investigational agent with limited published data to date.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female.
3. Have atopic dermatitis at screening.

Exclusion Criteria:

1. Hypersensitivity to the study drug or any ingredient in the study drug.
2. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
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. Females who are pregnant or lactating.

Where this trial is running

Guangzhou, Guangdong

• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Ran Li

Conditions Moderate-to-severe Atopic Dermatitis