Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis

April 23, 2026 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacokinetics of SHR-1819 Injection in Adults With Moderate to Severe Atopic Dermatitis

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Sub-Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol;
  2. Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
  3. Have atopic dermatitis at the time of screening (according to the 2014 American College of Dermatology Guidelines) and have a course of at least 1 year before screening;
  4. At the screening and baseline periods, EASI ≥ 16, IGA ≥ 3, BSA ≥ 10%;
  5. The average daily peak pruritus (itch) numerical evaluation scale (P-NRS) score for the first 7 days of randomization ≥ 4 points (at least 4 days of daily peak pruritus P-NRS scores need to be collected);
  6. According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Major surgeries are planned for the duration of the study;
  3. History of previous atopic corneal conjunctivitis involving the cornea;
  4. History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis;
  5. Subjects have had or are currently clinically significant diseases or abnormalities;
  6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;
  7. The drug has been used in the previous 6 months;
  8. Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma);
  9. Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;
  10. Any cause that the researchers believe would prevent the participants from participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group A: SHR-1819
Drug: SHR-1819
Treatment group A: SHR-1819 injection dose 1; Treatment group B: SHR-1819 injection dose 2; Treatment group C：SHR-1819 injection dose 3.
Experimental: Treatment group B: SHR-1819
Drug: SHR-1819
Treatment group A: SHR-1819 injection dose 1; Treatment group B: SHR-1819 injection dose 2; Treatment group C：SHR-1819 injection dose 3.
Experimental: Treatment group C: SHR-1819
Drug: SHR-1819
Treatment group A: SHR-1819 injection dose 1; Treatment group B: SHR-1819 injection dose 2; Treatment group C：SHR-1819 injection dose 3.
Placebo Comparator: Treatment group D: placebo
Drug: Placebo
Treatment group D: placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥ 75% from baseline)
Time Frame: Up to 16 weeks
EASI sore use EASI scale
Up to 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of adverse events ranged from the first dose to 24 weeks
Time Frame: From the beginning of administration to the 24th week
Assess the post-medication safety of subjects from the first dose to the time they exit the group
From the beginning of administration to the 24th week
At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 (0-4 scale) and a decrease of ≥ 2 points from baseline
Time Frame: Up to 16 weeks
The overall degree of improvement was assessed using the IGA scale
Up to 16 weeks
At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥ 2 points
Time Frame: Up to 16 weeks
The overall degree of improvement was assessed using the IGA scale
Up to 16 weeks
At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥ 90% lower than baseline)
Time Frame: Up to 16 weeks
The extent of area is assessed using the EASI scale
Up to 16 weeks
At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥ 50% lower than baseline)
Time Frame: Up to 16 weeks
The extent of area is assessed using the EASI scale
Up to 16 weeks
At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥ 4 points
Time Frame: Up to 16 weeks
The extent of pruritus is assessed using the P-NRS scale
Up to 16 weeks
At week 16, EASI is the percentage change from baseline and change
Time Frame: Up to 16 weeks
The extent of area is assessed using the EASI scale
Up to 16 weeks
At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change
Time Frame: Up to 16 weeks
The extent of lesions and pruritus is assessed using the SCORAD scale
Up to 16 weeks
At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change
Time Frame: Up to 16 weeks
The BSA scale was used to assess improvement in lesion area
Up to 16 weeks
At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change
Time Frame: Up to 16 weeks
The quality of Life is assessed using the DLQI scale
Up to 16 weeks
Concentration of SHR-1819 in serum
Time Frame: From the beginning of administration to the 24th week
From the beginning of administration to the 24th week
Changes of TARC/CCL17 in the serum
Time Frame: From the beginning of administration to the 24th week
From the beginning of administration to the 24th week
Changes of IgE in the serum
Time Frame: From the beginning of administration to the 24th week
From the beginning of administration to the 24th week
Changes of eotaxin-3 in the serum
Time Frame: From the beginning of administration to the 24th week
From the beginning of administration to the 24th week
Immunogenicity of SHR-1819
Time Frame: From the beginning of administration to the 24th week
From the beginning of administration to the 24th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR-1819-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings