Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
Primary Purpose
Plaque Psoriasis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tapinarof cream, 1%
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring plaque psoriasis, pediatric, phase 3, topical, tapinarof
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit
- Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline
- A PGA score of ≥ 2 at screening and baseline
- Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
- Must not be pregnant
- Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent
Exclusion Criteria:
- Psoriasis other than plaque variant
- Any sign of infection of any of the psoriatic lesions
- Immunocompromised at screening
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN)
- Screening total bilirubin > 1.5x ULN
- Current or chronic history of liver disease
- Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- Major surgery within 8 weeks prior to baseline or has a major surgery planned during the study
- Known history of clinically significant drug or alcohol abuse in the last year prior to baseline
- Use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation
- History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion may interfere with the subject's participation in the study, interpretation of results, safety of the subject or ability to understand and give informed consent
- Pregnant or lactating females.
- History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
- Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Sites / Locations
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical TrialsRecruiting
- Dermavant Clinical SiteRecruiting
- Dermavant Clinical SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence, frequency, and duration of treatment emergent AEs and SAEs
Number of subjects with clinically significant laboratory test abnormalities
Number of subjects with clinically significant vital signs abnormalities
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Secondary Outcome Measures
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.
Maximum observed plasma concentration (Cmax).
Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.
Time to maximum observed plasma concentration obtained directly from the observed concentration.
Full Information
NCT ID
NCT05172726
First Posted
October 28, 2021
Last Updated
September 7, 2023
Sponsor
Dermavant Sciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05172726
Brief Title
Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
Official Title
A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermavant Sciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
Detailed Description
This study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. At the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. Subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
plaque psoriasis, pediatric, phase 3, topical, tapinarof
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open Label
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tapinarof cream, 1%
Intervention Description
applied topically once daily
Primary Outcome Measure Information:
Title
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Incidence, frequency, and duration of treatment emergent AEs and SAEs
Time Frame
Screening up to Week 53
Title
Number of subjects with clinically significant laboratory test abnormalities
Time Frame
Screening up to Week 53
Title
Number of subjects with clinically significant vital signs abnormalities
Time Frame
Screening up to Week 53
Title
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Description
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Time Frame
Baseline up to Week 52
Title
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
Description
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Time Frame
Baseline up to Week 52
Secondary Outcome Measure Information:
Title
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.
Description
Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
Time Frame
Week 4 and Week 12
Title
Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.
Description
Maximum observed plasma concentration (Cmax).
Time Frame
Week 4 and Week 12
Title
Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.
Description
Time to maximum observed plasma concentration obtained directly from the observed concentration.
Time Frame
Week 4 and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit
Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline
A PGA score of ≥ 2 at screening and baseline
Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
Must not be pregnant
Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent
Exclusion Criteria:
Psoriasis other than plaque variant
Any sign of infection of any of the psoriatic lesions
Immunocompromised at screening
Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN)
Screening total bilirubin > 1.5x ULN
Current or chronic history of liver disease
Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
Major surgery within 8 weeks prior to baseline or has a major surgery planned during the study
Known history of clinically significant drug or alcohol abuse in the last year prior to baseline
Use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation
History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion may interfere with the subject's participation in the study, interpretation of results, safety of the subject or ability to understand and give informed consent
Pregnant or lactating females.
History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Brown, MD, JD
Phone
480-666-0844
Email
dermavantclinicaltrials@dermavant.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Villalobos
Organizational Affiliation
Dermavant Sciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dermavant Clinical Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Rancho Santa Margarita
State/Province
California
ZIP/Postal Code
92688
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
45324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Site
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
92688
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J7E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J3S9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E1V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P1X3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Trials
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H1B9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J1C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X2V1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
12. IPD Sharing Statement
Learn more about this trial
Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
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