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

NCT ID: NCT05326672

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2023-12-31

Brief 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.

Detailed Description

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Benvitimod Cream

Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment.

Group Type: EXPERIMENTAL

Benvitimod Cream

Intervention Type: DRUG

Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment.

Placebo

Placebo, applied twice daily for 8 weeks after enrolment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, applied twice daily for 8 weeks after enrolment.

Interventions

Benvitimod Cream

Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment.

Intervention Type: DRUG

Placebo

Placebo, applied twice daily for 8 weeks after enrolment.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhonghao Pharmaceutical

UNKNOWN

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang jianzhong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianzhong Zhang

Role: CONTACT

rmzjz@126.com

010-88325472

Yan Zhao

Role: CONTACT

zhaoyan377@hotmail.com

18500291610

Facility Contacts

Yan Zhao

Role: primary

zhaoyan377@hotmail.com

18500291610

Other Identifiers

TJ-BWMD-2021

Identifier Type: -

Identifier Source: org_study_id