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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07211542

Enrollment

Registered

2025-10-08

Start date

2025-11-07

Completion date

2027-02-01

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-severe Atopic Dermatitis

Brief summary

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

Interventions

DRUGSHR-1905 Injection

SHR-1905 injection.

DRUGSHR-1905 Injection Blank Preparation

SHR-1905 injection blank preparation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline.	Week 16.	Eczema Area and Severity Index (EASI) score using the Eczema Area and Severity Index scale.

Secondary

Measure	Time frame	Description
The proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale) and a decrease of ≥2 points from the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	Investigator's Global Assessment (IGA) score using the Investigator Global Assessment (IGA) scale.
The proportion of subjects whose Investigator's Global Assessment (IGA) score decreased ≥ 2 points compared to the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	Investigator's Global Assessment (IGA) score using the Investigator Global Assessment (IGA) scale.
The change value of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	The Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale.
The percentage of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	The Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale.
The proportion of subjects whose EASI score decreased ≥ 75% compared to the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	EASI score using the EASI scale.
The proportion of subjects whose EASI score decreased ≥ 90% compared to the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	EASI score using the EASI scale.
The proportion of subjects whose EASI score decreased ≥ 50% compared to the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	EASI score using the EASI scale.
The change value in EASI score from the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	EASI score using the EASI scale.
The percentage of change in EASI score from the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	EASI score using the EASI scale.
The change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	BSA score using the BSA scale.
The percentage of change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline.	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	BSA score using the BSA scale.
Adverse events (AEs).	At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.	—

Countries

China

Contacts

CONTACTRan Li

ran.li@hengrui.com+86-0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026