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Active, not recruitingNCT07321951Updated Jun 4, 2026

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

A Phase 2 interventional study of SHR-1819 Injection and SHR-1819 Injection Blank Preparation in Moderate-to-severe Atopic Dermatitis, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Moderate-to-severe Atopic Dermatitis
03

In context

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
201 participants (actual)

Study arms

  • Experimental
    SHR-1819 Injection Group with Dose 1

    Drug: SHR-1819 Injection · Drug: SHR-1819 Injection Blank Preparation

  • Experimental
    SHR-1819 Injection Group with Dose 2

    Drug: SHR-1819 Injection · Drug: SHR-1819 Injection Blank Preparation

  • Experimental
    SHR-1819 Injection Group with Dose 3

    Drug: SHR-1819 Injection · Drug: SHR-1819 Injection Blank Preparation

Interventions

  • DrugSHR-1819 Injection

    SHR-1819 injection.

  • DrugSHR-1819 Injection Blank Preparation

    SHR-1819 injection blank preparation.

06

What researchers measure

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.

    Time frame: Week 24.

Secondary outcomes

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

    The Itch Numeric Rating Scale score using the Itch Numeric Rating Scale.

    Time frame: Week 24.

  2. Adverse events (AEs).

    Time frame: About 42 weeks.

  3. The concentration of SHR-1819 in serum.

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

07

Study locations

2 sites
  • Dermatology Hospital of Southern Medical University
    Guangzhou, Guangdong 510091, China
  • Hangzhou Third People's Hospital
    Hangzhou, Zhejiang 310009, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07321951
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Jan 9, 2026
Primary completion
Jun 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jun 4, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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