Back to resultsPhase IV Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults
Primary Purpose
Psoriasis
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Benvitimod
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Benvitimod Cream, Psoriasis, Topical Treatment
Eligibility Criteria
Inclusion Criteria:
- Male and female participants ages at least 18 years.
- The participant with diagnosis of mild to moderate stable psoriasis vulgaris.
- BSA involvement <10%.
- Capable of giving written informed consent.
Exclusion Criteria:
- Planned Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation during the study period.
- Known allergies to the active ingredient or excipients of the drug.
- Pregnant females, lactating females.
- The patients who were considered unsuitable to participate in the study by the investigators.
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Cohort
Arm Description
Outcomes
Primary Outcome Measures
Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Percentage decline in Physician Global Assessment (PGA) score at Week 12
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.
Secondary Outcome Measures
Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 8
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Proportion of participants with ≥50% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Change in percent of total body surface area (%BSA) affected from Baseline to Week 8
The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. 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 psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Proportion of participants with ≥50% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Change in percent of total body surface area (%BSA) affected from Baseline to Week 12
The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. 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 psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Change of Psoriasis Area and Severity Index (PASI) score over time from Baseline to Week 12.
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
The Dermatology Life Quality Index (DLQI) total and individual dimension scores.
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.
European Questionnaires Five Dimensions Five Levels (EQ-5D-5L) scores.
EQ-5D-5L is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Full Information
NCT ID
NCT05064748
First Posted
September 22, 2021
Last Updated
September 22, 2021
Sponsor
Peking University People's Hospital
Collaborators
Zhonghao Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT05064748
Brief Title
Phase IV Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults
Official Title
A Multi-center, Open-Label, Extension Study to Evaluate the Safety and Efficacy of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Zhonghao Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multi-center, prospective post-approval clinical Phase IV study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will use the Benvitimod cream at the skin with psoriasis for 12 weeks.
Detailed Description
This is a multi-center, prospective post-approval clinical Phase IV study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will apply the Benvitimod cream on the skin with plaque psoriasis for maximum 12 weeks. All participants will complete follow-up visits at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks and continuing up to one year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Benvitimod Cream, Psoriasis, Topical Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Cohort
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Benvitimod
Intervention Description
Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.
Primary Outcome Measure Information:
Title
Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 12
Title
Percentage decline in Physician Global Assessment (PGA) score at Week 12
Description
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 8
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
Proportion of participants with ≥50% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
Change in percent of total body surface area (%BSA) affected from Baseline to Week 8
Description
The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. 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 psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 12
Title
Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 12
Title
Proportion of participants with ≥50% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 12
Title
Change in percent of total body surface area (%BSA) affected from Baseline to Week 12
Description
The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. 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 psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Time Frame
Week 12
Title
Change of Psoriasis Area and Severity Index (PASI) score over time from Baseline to Week 12.
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) 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 PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 12
Title
The Dermatology Life Quality Index (DLQI) total and individual dimension scores.
Description
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 16
Title
European Questionnaires Five Dimensions Five Levels (EQ-5D-5L) scores.
Description
EQ-5D-5L is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female participants ages at least 18 years.
The participant with diagnosis of mild to moderate stable psoriasis vulgaris.
BSA involvement <10%.
Capable of giving written informed consent.
Exclusion Criteria:
Planned Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation during the study period.
Known allergies to the active ingredient or excipients of the drug.
Pregnant females, lactating females.
The patients who were considered unsuitable to participate in the study by the investigators.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Liu
Phone
010 88325472
Email
llppliuping@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase IV Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults
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