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

NCT05549947 | Completed Phase 2

• 1 other identifier: SHR-1819-201
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moderate to Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥ 75% from baseline)

  EASI sore use EASI scale

  Up to 16 weeks

Secondary Outcomes (15)

• 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

  Up to 16 weeks

• At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥ 2 points

  Up to 16 weeks

• At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥ 90% lower than baseline)

  Up to 16 weeks

• At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥ 50% lower than baseline)

  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

  Up to 16 weeks

Study Arms (4)

Treatment group A: SHR-1819

EXPERIMENTAL

Drug: SHR-1819

Treatment group B: SHR-1819

EXPERIMENTAL

Drug: SHR-1819

Treatment group C: SHR-1819

EXPERIMENTAL

Drug: SHR-1819

Treatment group D: placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-1819 DRUG

Treatment group A: SHR-1819 injection dose 1; Treatment group B: SHR-1819 injection dose 2; Treatment group C：SHR-1819 injection dose 3.

Treatment group A: SHR-1819; Treatment group B: SHR-1819; Treatment group C: SHR-1819

Placebo DRUG

Treatment group D: placebo

Treatment group D: placebo

Eligibility Criteria

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

You may qualify if:

• 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;
• Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
• 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;
• At the screening and baseline periods, EASI ≥ 16, IGA ≥ 3, BSA ≥ 10%;
• 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);
• According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening.

You may not qualify if:

• Pregnant or lactating women;
• Major surgeries are planned for the duration of the study;
• History of previous atopic corneal conjunctivitis involving the cornea;
• 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;
• Subjects have had or are currently clinically significant diseases or abnormalities;
• Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;
• The drug has been used in the previous 6 months;
• 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);
• Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;
• Any cause that the researchers believe would prevent the participants from participating in the study.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Sub-Hospital of Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: October 8, 2022
• Primary Completion: September 15, 2023
• Study Completion: November 23, 2023
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CN (1)