A Study of SHR-1819 in Patients With Moderate-to-severe Atopic Dermatitis

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Moderate-to-severe Atopic Dermatitis

Treatments: Drug: SHR-1819 Injection; Drug: SHR-1819 Injection Blank Preparation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07321951

SHR-1819-207

Details and patient eligibility

About

This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult patients with moderate-to-severe atopic dermatitis.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 3 patient groups

SHR-1819 Injection Group with Dose 1

Experimental group

Treatment:

Drug: SHR-1819 Injection Blank Preparation

Drug: SHR-1819 Injection

SHR-1819 Injection Group with Dose 2

Experimental group

Treatment:

Drug: SHR-1819 Injection Blank Preparation

Drug: SHR-1819 Injection

SHR-1819 Injection Group with Dose 3

Experimental group

Treatment:

Drug: SHR-1819 Injection Blank Preparation

Drug: SHR-1819 Injection