Phase III Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with atopic dermatitis for 8 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborator: Zhonghao Pharmaceutical

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Diagnosis of atopic dermatitis，course of disease ≥ 6 months，EASI ≤ 21 and 3% ≤ BSA ≤ 20%.

• IGA ≥ 3.

• Capable of giving written informed consent.

Exclusion Criteria:

• Skin lesions were limited to head, neck, hands and feet.

• ALT/AST ≥ 3 ULN、BUN/Cr ﹥ 1.5 ULN.

• Subjects with obvious cardiovascular, respiratory, gastrointestinal, liver, kidney, blood, neurological and psychological diseases that are unstable or not well controlled.

• Subjects have any systemic disease or other active skin disease that may affect the evaluation of the study results, or have scar, freckle, tattoo, etc. in the affected area that may affect the evaluation of skin lesions.

• Subjects with malignant neoplasms.

• Subjects with severe comorbid conditions may require systematic hormone therapy or other interventions, affect study participation or require frequent active monitoring (e.g., unstable chronic asthma).

• Subjects with definite skin infection with local bacteria, viruses and fungi.

• Subjects with mental illness or other reasons may interfere with participation in the study.

• Known to be allergic to any of the components of the drug.

• Severe hypersensitivity to food, drugs, insect venom, rubber, etc.

• Women who are pregnant, breast-feeding, or planning to become pregnant.

• Alcohol, drug abuse and known drug dependence.

• Prior to enrollment, the following treatments were used within the specified time period:

1. External medication used within 2 weeks (e.g. glucocorticoids, calcineurin inhibitors, tacrolimus, PDE-4 inhibitors, etc.)

2. Systemic immunotherapy used within 4 weeks (e.g., glucocorticoids, methotrexate, JAK inhibitors, cyclosporine, etc.).

3. Received biologics for atopic dermatitis (e.g., IL-4 inhibitors, IL-13 inhibitors, etc.) within 4 weeks (or 5 half-life, whichever is longer).

4. Received uv therapy and photochemotherapy within 4 weeks.

• Participated in clinical trials of other drugs or medical devices within 4 weeks.

• The patients who were considered unsuitable to participate in the study by the investigators.