A Study to Investigate the Efficacy and Safety of SHR-1905 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-1905 Injection Blank Preparation; Drug: SHR-1905 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07211542

SHR-1905-205

Details and patient eligibility

About

This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-severe atopic dermatitis.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

SHR-1905 Injection Group - Dose 1

Experimental group

Description:

Dose 1.

Treatment:

Drug: SHR-1905 Injection

SHR-1905 Injection Placebo Group

Placebo Comparator group

Treatment:

Drug: SHR-1905 Injection Blank Preparation

SHR-1905 Injection Group - Dose 2

Experimental group

Description:

Dose 2.

Treatment:

Drug: SHR-1905 Injection