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This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tapinarof cream, 1% | Drug | applied topically once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence, frequency, and duration of treatment emergent AEs and SAEs | Screening up to Week 53 |
| Number of subjects with clinically significant laboratory test abnormalities | Screening up to Week 53 | |
| Number of subjects with clinically significant vital signs abnormalities | Screening up to Week 53 | |
| 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. | Baseline up to Week 52 |
| 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. | Baseline up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 and Week 12 |
| Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Lead Late-Stage Clinical Development | Organon and Co | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Arkansas Clinical Trials Center, PLLC | Rogers | Arkansas | 72758 | United States | ||
| First OC Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38777187 | Derived | Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, Kircik L. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20. |
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Maximum observed plasma concentration (Cmax). |
| Week 4 and Week 12 |
| Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%. | Time to maximum observed plasma concentration obtained directly from the observed concentration. | Week 4 and Week 12 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Mission Dermatology Center | Rancho Santa Margarita | California | 92688 | United States |
| RM Medical Research | Miami Lakes | Florida | 33014 | United States |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | United States |
| Olympian Clinical Research | Tampa | Florida | 33615 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Dawes Fretzin Clinical Research Group | Indianapolis | Indiana | 46250 | United States |
| Options Research Group | West Lafayette | Indiana | 47906 | United States |
| Wright State Physicians Pharmacology Translational Unit | Fairborn | Ohio | 45324 | United States |
| Oregon Dermatology & Research Center | Portland | Oregon | 97210 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Dermatology Research Institute Inc. | Calgary | Alberta | T2J7E1 | Canada |
| Rejuvenation Laser Dermatology Clinics | Edmonton | Alberta | T5J3S9 | Canada |
| Skincare Studio INC | St. John's | Newfoundland and Labrador | A1E1V4 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P1X3 | Canada |
| Alliance Clinical Trials | Waterloo | Ontario | N2J 1C4 | Canada |
| Whitby Health Centre Dermatology Trials | Whitby | Ontario | L1P0P9 | Canada |
| Innovaderm Research, Inc. | Montreal | Quebec | H2X 2V1 | Canada |