Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
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| ClinicalTrials.gov Identifier: NCT05172726 |
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Recruitment Status :
Recruiting
First Posted : December 29, 2021
Last Update Posted : March 27, 2023
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Sponsor:
Dermavant Sciences, Inc.
Information provided by (Responsible Party):
Dermavant Sciences, Inc.
- Study Details
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Brief Summary:
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: tapinarof cream, 1% | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects |
| Actual Study Start Date : | December 2, 2021 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Psoriasis
Drug Information available for:
Tapinarof
| Arm | Intervention/treatment |
|---|---|
| Experimental: Open Label |
Drug: tapinarof cream, 1%
applied topically once daily |
Primary Outcome Measures :
- Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to Week 53 ]Incidence, frequency, and duration of treatment emergent AEs and SAEs
- Number of subjects with clinically significant laboratory test abnormalities [ Time Frame: Screening up to Week 53 ]
- Number of subjects with clinically significant vital signs abnormalities [ Time Frame: Screening up to Week 53 ]
- Investigator-Assessed Local Tolerability Scale (LTS) Scores [ Time Frame: Baseline up to Week 52 ]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) [ Time Frame: Baseline up to Week 52 ]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%. [ Time Frame: Week 4 and Week 12 ]Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
- Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%. [ Time Frame: Week 4 and Week 12 ]Maximum observed plasma concentration (Cmax).
- Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%. [ Time Frame: Week 4 and Week 12 ]Time to maximum observed plasma concentration obtained directly from the observed concentration.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 2 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05172726
Contacts
| Contact: Philip Brown, MD, JD | 480-666-0844 | dermavantclinicaltrials@dermavant.com |
Locations
| United States, Arkansas | |
| Dermavant Clinical Site | Recruiting |
| Rogers, Arkansas, United States, 33756 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
| United States, Florida | |
| Dermavant Clinical Site | Recruiting |
| Miami Lakes, Florida, United States, 45324 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
| United States, Indiana | |
| Dermavant Clinical Site | Recruiting |
| Indianapolis, Indiana, United States, 60611 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
| Dermavant Clinical Site | Recruiting |
| West Lafayette, Indiana, United States, 72758 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
| United States, Ohio | |
| Dermavant Clinical Site | Recruiting |
| Fairborn, Ohio, United States, 99202 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
| United States, Oregon | |
| Dermavant Clinical Site | Recruiting |
| Portland, Oregon, United States, 47906 | |
| Contact: Dermavant Clinical Site dermavantclinicaltrials@dermavant.com | |
| United States, Washington | |
| Dermavant Clinical Site | Recruiting |
| Spokane, Washington, United States, 92688 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
| Canada, Ontario | |
| Dermavant Clinical Site | Recruiting |
| Markham, Ontario, Canada, H2X2V1 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
| Dermavant Clinical Trials | Recruiting |
| Oshawa, Ontario, Canada, L1H1B9 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
| Dermavant Clinical Site | Recruiting |
| Waterloo, Ontario, Canada, N2J1C4 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
| Canada, Quebec | |
| Dermavant Clinical Site | Recruiting |
| Montréal, Quebec, Canada, H2X 2v1 | |
| Contact: Dermavant Clinical Trials dermavantclinicaltrials@dermavant.com | |
Sponsors and Collaborators
Dermavant Sciences, Inc.
Investigators
| Study Director: | Diana Villalobos | Dermavant Sciences, Inc. |
Publications of Results:
Other Publications:
Other Publications:
Cappon GD and Hurtt ME. Developmental toxicity of the kidney. In: Kapp RW and Yyl L, editors. Reproductive Toxicology, Target Organ Series, 3rd edition. New York:Informa Healthcare, 2010:;93-204.
Frazier KS and Seely JC. Urinary system. In: Sahota PS, Popp JA, Hardisty JF and Gopinath C, editors. Toxicologic Pathology: Nonclinical Safety Assessment. CRC Press, 2013;421-84.
| Responsible Party: | Dermavant Sciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT05172726 |
| Other Study ID Numbers: |
DMVT-505-3004 |
| First Posted: | December 29, 2021 Key Record Dates |
| Last Update Posted: | March 27, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Dermavant Sciences, Inc.:
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plaque psoriasis pediatric phase 3 topical tapinarof |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases |