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

NCT06012812 | Completed Phase 2

• 1 other identifier: SHR-1819-203
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main study, referred to as the main study hereinafter).

Conditions

Moderate to Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events (TEAEs) (per person-year)

  Up to 60 weeks

Secondary Outcomes (8)

• Serious Adverse Event (SAE) during treatment (per person-year)

  Up to 60 weeks

• Adverse Events of Special Interest (AESI) during treatment (per person-year)

  Up to 60 weeks

• Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit

  Up to 60 weeks

• Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)

  Up to 60 weeks

• Proportion of participants with at least 1 remission in this study

  Up to 60 weeks

Study Arms (1)

SHR-1819 injection

EXPERIMENTAL

Drug: SHR-1819 injection

Interventions

SHR-1819 injection DRUG

SHR-1819 injection 300 mg Q2W

SHR-1819 injection

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 age of 18\~75 years old at the time of signing the informed consent form (including the values at both ends), gender is not limited；
• Be able to apply a topical emollient (moisturizer) continuously for at least 7 consecutive days before the first dose and continue to use it for the duration of the study;
• Be able to sign informed consent forms, understand and agree to follow the requirements of the study and the trial process.

You may not qualify if:

• Pregnant or lactating women；
• Female subjects of childbearing potential and male subjects whose partners are women of childbearing age have a plan to donate sperm/eggs from the signing of the informed consent form until 3 months after the last dose of the trial drug, or refuse to comply with the relevant contraceptive requirements;
• A history of alcohol abuse or illicit drug abuse within 6 months prior to screening;
• Hypersensitivity to the study drug or any ingredient in the study drug；
• Diagnosed within 6 months prior to screening or judged by the investigator to have a suspected immunosuppressive disease;
• Oral or parenteral systemic antimicrobials are used within 2 weeks before the first dose；
• Suspected or confirmed active tuberculosis (TB);
• Have malignancy or history of malignancy prior to screening；
• Major surgery was performed within 3 months prior to screening, or major surgery was planned during the study；
• There are currently significant abnormal laboratory test results, severe concomitant diseases, and other circumstances that the investigator considers inappropriate to participate in this trial;
• There were treatment-related adverse events leading to discontinuation of treatment and study drug-related SAEs in the main study, and the investigator or sponsor medical department considered that continuing to participate in extended therapy would pose an unacceptable safety risk to participants.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: September 6, 2023
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (1)