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

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis

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.

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. Participants who had completed the 8-week clinical trial and were well tolerant to the drug were followed up in one-arm, long-term intermittent administration (up to 52 weeks period). In the long-term medication phase, at each visit point: ① When IGA ≥ 2, Benvitimod cream was continued to be used, twice daily. ② When IGA < 2, the drug was stopped. In the long-term follow-up, the interval of visits was 4 weeks during the medication phase and 8 weeks during the discontinuation phase.

The primary objective is to evaluate the efficacy and safety of Benvitimod cream in the treatment of mild to moderate atopic dermatitis. The primary endpoint is the proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from baseline to week 8. The study is anticipated to last from April 2022 to August 2023 with 240 participants recruited form about 20 centers in China.

All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. The study has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Peking University People's Hospital.

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.