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

NCT05326672 | Unknown Phase 3

• 1 other identifier: TJ-BWMD-2021
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Benvitimod Cream; Atopic Dermatitis; Topical Treatment

Outcome Measures

Primary Outcomes (1)

• 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 IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis at a given timepoint. It is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema and induration as guidelines. Higher IGA scores represent more severe disease.

  Week 8

Secondary Outcomes (19)

• Percentage decline in Eczema Area and Severity Index (EASI) score from Baseline to Week 8

  Week 8

• Proportion of participants with ≥75% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8

  Week 8

• Proportion of participants with ≥90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8

  Week 8

• Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8

  Week 8

• Proportion of participants with ≥3 score improvement in Pruritus Visual Analogue Scale (VAS) from Baseline to Week 8

  Week 8

Study Arms (2)

Benvitimod Cream

EXPERIMENTAL

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

Drug: Benvitimod Cream

Placebo

PLACEBO COMPARATOR

Placebo, applied twice daily for 8 weeks after enrolment.

Drug: Placebo

Interventions

Benvitimod Cream DRUG

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

Benvitimod Cream

Placebo DRUG

Placebo, applied twice daily for 8 weeks after enrolment.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• External medication used within 2 weeks (e.g. glucocorticoids, calcineurin inhibitors, tacrolimus, PDE-4 inhibitors, etc.)
• Systemic immunotherapy used within 4 weeks (e.g., glucocorticoids, methotrexate, JAK inhibitors, cyclosporine, etc.).

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Zhonghao Pharmaceutical: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Jianzhong Zhang

CONTACT

010-88325472; rmzjz@126.com

Yan Zhao

CONTACT

18500291610; zhaoyan377@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)