A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis

NCT07211542 | Recruiting Phase 2

• 1 other identifier: SHR-1905-205
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moderate-to-severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline.

  Eczema Area and Severity Index (EASI) score using the Eczema Area and Severity Index scale.

  Week 16.

Secondary Outcomes (12)

• 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.

• 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.

• 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 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 proportion of subjects whose EASI score decreased ≥ 75% compared to the baseline.

  At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.

Study Arms (3)

SHR-1905 Injection Group - Dose 1

EXPERIMENTAL

Dose 1.

Drug: SHR-1905 Injection

SHR-1905 Injection Placebo Group

PLACEBO COMPARATOR

Drug: SHR-1905 Injection Blank Preparation

SHR-1905 Injection Group - Dose 2

EXPERIMENTAL

Dose 2.

Drug: SHR-1905 Injection

Interventions

SHR-1905 Injection DRUG

SHR-1905 injection.

SHR-1905 Injection Group - Dose 1; SHR-1905 Injection Group - Dose 2

SHR-1905 Injection Blank Preparation DRUG

SHR-1905 injection blank preparation.

SHR-1905 Injection Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female.
• Have atopic dermatitis at screening.

You may not qualify if:

• Hypersensitivity to the study drug or any ingredient in the study drug.
• Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
• Has malignancy or has a history of malignancy.
• Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
• Females who are pregnant or lactating.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

RECRUITING

Central Study Contacts

Ran Li

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (1)