NCT07321951

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
15mo left

Started Jan 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Aug 2027

First Submitted

Initial submission to the registry

December 21, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 9, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

December 21, 2025

Last Update Submit

April 2, 2026

Conditions

Moderate-to-severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline).

    Eczema Area and Severity Index score using the Eczema Area and Severity Index scale.

    Week 24.

Secondary Outcomes (3)

  • The proportion of participants with a baseline daily Itch Numeric Rating Scale (I-NRS) score of ≤4 per week.

    Week 24.

  • Adverse events (AEs).

    About 42 weeks.

  • The concentration of SHR-1819 in serum.

    From week -16 to week -8, about every 4 weeks; From week 0 to week 32, about every 8 weeks.

Study Arms (3)

SHR-1819 Injection Group with Dose 1

EXPERIMENTAL
Drug: SHR-1819 InjectionDrug: SHR-1819 Injection Blank Preparation

SHR-1819 Injection Group with Dose 2

EXPERIMENTAL
Drug: SHR-1819 InjectionDrug: SHR-1819 Injection Blank Preparation

SHR-1819 Injection Group with Dose 3

EXPERIMENTAL
Drug: SHR-1819 InjectionDrug: SHR-1819 Injection Blank Preparation

Interventions

SHR-1819 InjectionDRUG

SHR-1819 injection.

SHR-1819 Injection Group with Dose 1SHR-1819 Injection Group with Dose 2SHR-1819 Injection Group with Dose 3
SHR-1819 Injection Blank PreparationDRUG

SHR-1819 injection blank preparation.

SHR-1819 Injection Group with Dose 1SHR-1819 Injection Group with Dose 2SHR-1819 Injection Group with Dose 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At the time of signing the informed consent, the subjects are ≥18 years old and ≤75 years old, male or female.
  • 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.
  • 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.
  • Have atopic dermatitis at the time of screening and have an investigator-assessed history of atopic dermatitis for at least 1 year before screening.
  • Have moderate to severe atopic dermatitis during the screening period and on the day of the first dose.

You may not qualify if:

  • Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
  • A history of spring keratoconjunctivitis and/or atopic keratoconjunctivitis within 6 months prior to screening.
  • 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.
  • Hypersensitivity to the study drug or any ingredient in the study drug.
  • Females who are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

RECRUITING

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310009, China

RECRUITING

Central Study Contacts

Ran Li

CONTACT

+86-0518-82342973ran.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

December 21, 2025

First Posted

January 7, 2026

Study Start

January 9, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

CN(2)