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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 3

Conditions: Moderate to Severe Atopic Dermatitis

Treatments: Drug: SHR-1819; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06468956

SHR-1819-301

Details and patient eligibility

About

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

Enrollment: 652 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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. The age was ≥18 at the time of signing the informed consent and gender is unlimited;
3. 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;
4. EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods;
5. TCS was not optimal or not tolerated by the investigator.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

652 participants in 3 patient groups, including a placebo group

SHR-1819 injection dose 1

Experimental group

Treatment:

Drug: SHR-1819

SHR-1819 injection dose 2

Experimental group

Treatment:

Drug: SHR-1819

placebo

Placebo Comparator group

Treatment:

Drug: Placebo