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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment.
Placebo, applied twice daily for 8 weeks after enrolment.
Peking University People's Hospital
Beijing, China
RECRUITINGProportion 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.
Time frame: Week 8
Percentage decline in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis. The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Time frame: Week 8
Proportion of participants with ≥75% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis. The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
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Time frame: Week 8
Proportion of participants with ≥90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis. The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Time frame: Week 8
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis. The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Time frame: Week 8
Proportion of participants with ≥3 score improvement in Pruritus Visual Analogue Scale (VAS) from Baseline to Week 8
Pruritus Visual Analogue Scale (VAS) will be used to assess severity of pruritus.
Time frame: Week 8
Overall EASI improvement rate and its changes with time from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis. The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Time frame: Week 8
The average IGA decrease and its changes with time 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.
Time frame: Week 8
The average DLQI decrease and its changes with time from Baseline to Week 8
The DLQI is a simple dermatology-specific 10-question validated questionnaire to assess the impact of the disease on a participant's quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
Time frame: Week 8
The average BSA decrease and its changes with time from Baseline to Week 8
The assessment of %BSA affected is an estimate of the percentage of total involved skin with atopic dermatitis. For the purpose of clinical estimation, the total palmar surface of the participant's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by atopic dermatitis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Time frame: Week 8
The average Pruritus Visual Analogue Scale (VAS) decrease and its changes with time from Baseline to Week 8
Pruritus Visual Analogue Scale (VAS) will be used to assess severity of pruritus.
Time frame: Week 8
Proportion of participants with recurrence and the time of first recurrence of 1.0% Benvitimod cream
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Time frame: Week 52
Proportion of participants of IGA = 0 or 1 was achieved after retreatment 8 weeks in recurrence subjects
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Time frame: Week 52
Incidence of TEAE and SAE
TEAE definition: treatment emergent adverse event.
Time frame: Week 52
Number of recurrences in recurrence participants
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Time frame: Week 52
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score after retreatment 8 weeks in recurrence subjects
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Time frame: Week 52
EASI score and IGA score decreased after retreatment 8 weeks in recurrence participants
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis. The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores. The IGA is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 6-point morphological assessment of overall disease severity, as determined by the investigator, using
Time frame: Week 52
Incidence of AE/ADR at each visit during medication
AE definition: adverse event. ADR definition: adverse reaction.
Time frame: Week 52
Incidence of SAE and TEAE leading to discontinuation
SAE definition: serious adverse events. TEAE definition: treatment emergent adverse event.
Time frame: Week 52
Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
Time frame: Week 52