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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study evaluating calcipotriene foam, 0.005% in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. Subjects or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day on the body and scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated.
This is a multicenter, open-label, Phase 1 study in a total of 75 pediatric subjects, ages 2 to 11 years, inclusive, with mild or moderate plaque psoriasis.
The study will enroll sufficient subjects with plaque psoriasis and an ISGA score of mild to moderate (score of 2 or 3) at Baseline to ensure 50 evaluable subjects in a general use cohort.
In addition, a sufficient number of subjects with moderate plaque psoriasis will be enrolled to ensure 25 evaluable subjects in a 'maximum-use' cohort that have:
A. At least 10% total BSA with some scalp involvement (15 evaluable subjects ages 7 to 11 years) or B. At least 3% total BSA with some scalp involvement (10 evaluable subjects ages 2 to 6 years). "Napkin" psoriasis (psoriasis in the diaper area) can be included in the BSA calculation for this age group.
Subjects or their caregivers will apply a thin layer of study product twice a day to the treatment areas for 8 weeks. Any new psoriatic lesions appearing in treatment areas during the treatment period should also be treated with study product. Safety assessments (adverse event and serious adverse event query) will occur at all study visits. Treatment effect assessments, urine calcium metabolism assessments, and application site tolerability assessments will be performed for all subjects at all in-clinic visits. A blood sample will be taken from all subjects at Screening for evaluation of pharmacodynamic (PD) and 2,5-OH vitamin D levels, an additional blood draw for PD parameters will be taken at Week 2 for the maximum-use cohort only. Blood sampling for pharmacokinetic (PK) measurements will be performed in the maximum-use cohort at Screening and Week 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcipotriene 0.005% Foam | Experimental | Foam is a vitamin D3 analog (calcipotriene) foam 0.005%. It is applied twice a day for 8 weeks to psoriasis lesions (except the face). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriene 0.005% Foam | Drug | All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of treatment effect and change in ISGA scores of body and scalp psoriasis (Safety and Tolerability) | To evaluate the safety and tolerability of calcipotriene foam, 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. An evaluation of treatment effect will include changes in ISGA scores of body and scalp psoriasis from baseline. Safety will be assessed based on vital signs, reported adverse events (AEs), use of concomitant medications, and application site tolerability assessments. | 56 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations (trough) of calcipotriene | Describe the plasma concentrations (trough) of calcipotriene following administration of foam, 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with moderate plaque psoriasis. | 8 weeks |
| Pharmacodynamic effect |
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A. At least 10% total BSA with some scalp involvement (15 evaluable subjects ages 7 to 11 years) or B. At least 3% total BSA with some scalp involvement (10 evaluable subjects ages 2 to 6 years). "Napkin" psoriasis (ie, psoriasis in the diaper area) can be included in the BSA calculation for this age group.
Key Inclusion Criteria:
A. ISGA of 3 or higher at Screening (see Appendix 2). Ages 7 to 11 - at least 10% total BSA with some scalp involvement (See Appendix 1).
Ages 2 to 6 - at least 3% total BSA (napkin psoriasis included) with some scalp involvement (See Appendix 1).
-For the general use cohort, an ISGA score of 2 or 3 at Screening with no BSA minimum.
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Mudge | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| Investigational Site |
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|
To evaluate the pharmacodynamic effect (ie, calcium metabolism) of calcipotriene foam 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. |
| 2 weeks |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Investigational Site | Encino | California | 91436 | United States |
| Fountain Valley | California | 92708 | United States |
| Santa Ana | California | 92705 | United States |
| Sherman Oaks | California | 91403 | United States |
| Investigational Site | Hollywood | Florida | 33021 | United States |
| Investigational Site | Jacksonville | Florida | 32204 | United States |
| Miami | Florida | 33014 | United States |
| Investigational Site | Miami | Florida | 33136 | United States |
| Investigational Site | Tampa | Florida | 33690 | United States |
| Investigational Site | Alpharetta | Georgia | 30022 | United States |
| Atlanta | Georgia | 30342 | United States |
| Investigational Site | Marietta | Georgia | 30060 | United States |
| Investigational Site | Sandy Springs | Georgia | 30328 | United States |
| Investigational Site | Chicago | Illinois | 60614 | United States |
| Investigational Site | Plainfield | Indiana | 46188 | United States |
| Brighton | Massachusetts | 02135 | United States |
| Investigational Site | Farmington Hills | Michigan | 48334 | United States |
| Saint Joseph | Missouri | 64506 | United States |
| Investigational Site | St Louis | Missouri | 63104 | United States |
| Investigational Site | St Louis | Missouri | 63117 | United States |
| Investigational Site | New York | New York | 10467 | United States |
| Investigational Site | Chapel Hill | North Carolina | 27516 | United States |
| Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| Investigational Site | Portland | Oregon | 97239 | United States |
| Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | 19109 | United States |
| Investigational Site | Austin | Texas | 78723 | United States |
| Investigational Site | Houston | Texas | 77030 | United States |
| Investigational Site | Houston | Texas | 77056 | United States |
| San Antonio | Texas | 78218 | United States |
| Investigational Site | Salt Lake City | Utah | 84132-2409 | United States |
| Investigational Site | Norfolk | Virginia | 23502 | United States |
| Investigational Site | Spokane | Washington | 99202 | United States |
| Investigational Site | Tacoma | Washington | 98418 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
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