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
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosis of atopic dermatitis，course of disease ≥ 6 months，EASI ≤ 21 and 3% ≤ BSA ≤ 20%.
- •Capable of giving written informed consent.
排除标准
- •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.).
- •Received biologics for atopic dermatitis (e.g., IL-4 inhibitors, IL-13 inhibitors, etc.) within 4 weeks (or 5 half-life, whichever is longer).
- •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.
研究组 & 干预措施
Benvitimod Cream
Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment.
干预措施: Benvitimod Cream (Drug)
Placebo
Placebo, applied twice daily for 8 weeks after enrolment.
干预措施: Placebo (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Number of recurrences in recurrence participants(Week 52)
- Incidence of SAE and TEAE leading to discontinuation(Week 52)
- 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 recurrence and the time of first recurrence of 1.0% Benvitimod cream(Week 52)
- Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)(Week 52)
- Proportion of participants with ≥75% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8(Week 8)
- The average DLQI decrease and its changes with time from Baseline to Week 8(Week 8)
- The average BSA decrease and its changes with time from Baseline to Week 8(Week 8)
- The average Pruritus Visual Analogue Scale (VAS) decrease and its changes with time from Baseline to Week 8(Week 8)
- Proportion of participants of IGA = 0 or 1 was achieved after retreatment 8 weeks in recurrence subjects(Week 52)
- Percentage decline 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 ≥3 score improvement in Pruritus Visual Analogue Scale (VAS) from Baseline to Week 8(Week 8)
- Overall EASI improvement rate and its changes with time from Baseline to Week 8(Week 8)
- The average IGA decrease and its changes with time from Baseline to Week 8(Week 8)
- Incidence of TEAE and SAE(Week 52)
- Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score after retreatment 8 weeks in recurrence subjects(Week 52)
- Incidence of AE/ADR at each visit during medication(Week 52)
- EASI score and IGA score decreased after retreatment 8 weeks in recurrence participants(Week 52)
研究者
Zhang jianzhong
Professor
Peking University People's Hospital