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

NCT06468956 | Active Not Recruiting Phase 3

• 1 other identifier: SHR-1819-301
• Study Type: interventional
• Target: 652
• 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 (2)

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

  The extent of area is assessed using the EASI scale

  up to 16 weeks

• At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 and a decrease of ≥2 points from baseline

  The overall degree of improvement was assessed using the IGA scale

  up to 16 week

Secondary Outcomes (12)

• The proportion of subjects whose weekly mean of the daily (PP-NRS) score decreased by 4 points from baseline at Week 16

  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

• Proportion of subjects reaching EASI-75 at other visit viewpoints

  up to 52 weeks

• The proportion of subjects with IGA score of 0 or 1 and 2 points from baseline

  up to 52 weeks

• Proproportion of subjects with a 2 points from baseline at each iGA

  up to 52 weeks

Study Arms (3)

SHR-1819 injection dose 1

EXPERIMENTAL

Drug: SHR-1819

SHR-1819 injection dose 2

EXPERIMENTAL

Drug: SHR-1819

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-1819 DRUG

SHR-1819 injection

SHR-1819 injection dose 1; SHR-1819 injection dose 2

Placebo DRUG

placebo

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；
• The age was ≥18 at the time of signing the informed consent and gender is unlimited;
• Atopic dermatitis at screening (according to the 2014 American Society of Dermatology guideline criteria, see Annex 1) and disease duration for at least 1 year before screening as judged by the investigator;
• EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods;
• TCS was not optimal or not tolerated by the investigator.

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

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Shanghai Fudan University HuaShan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: May 24, 2024
• First Posted: June 21, 2024
• Study Start: June 14, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

CN (1)