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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-09

Study Completion Date

2027-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Moderate-to-severe Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-1819 Injection Group with Dose 1

Group Type EXPERIMENTAL

SHR-1819 Injection

Intervention Type DRUG

SHR-1819 injection.

SHR-1819 Injection Blank Preparation

Intervention Type DRUG

SHR-1819 injection blank preparation.

SHR-1819 Injection Group with Dose 2

Group Type EXPERIMENTAL

SHR-1819 Injection

Intervention Type DRUG

SHR-1819 injection.

SHR-1819 Injection Blank Preparation

Intervention Type DRUG

SHR-1819 injection blank preparation.

SHR-1819 Injection Group with Dose 3

Group Type EXPERIMENTAL

SHR-1819 Injection

Intervention Type DRUG

SHR-1819 injection.

SHR-1819 Injection Blank Preparation

Intervention Type DRUG

SHR-1819 injection blank preparation.

Interventions

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SHR-1819 Injection

SHR-1819 injection.

Intervention Type DRUG

SHR-1819 Injection Blank Preparation

SHR-1819 injection blank preparation.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No