A Study to Investigate the Efficacy and Safety of SHR-1905 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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-07

Study Completion Date

2027-02-28

Brief Summary

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This trial was designed to evaluate the efficacy and safety of SHR-1905 in 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-1905 Injection Group - Dose 1

Dose 1.

Group Type EXPERIMENTAL

SHR-1905 Injection

Intervention Type DRUG

SHR-1905 injection.

SHR-1905 Injection Placebo Group

Group Type PLACEBO_COMPARATOR

SHR-1905 Injection Blank Preparation

Intervention Type DRUG

SHR-1905 injection blank preparation.

SHR-1905 Injection Group - Dose 2

Dose 2.

Group Type EXPERIMENTAL

SHR-1905 Injection

Intervention Type DRUG

SHR-1905 injection.

Interventions

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SHR-1905 Injection

SHR-1905 injection.

Intervention Type DRUG

SHR-1905 Injection Blank Preparation

SHR-1905 injection blank preparation.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No