Clinical trial NCT01582932: Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis
Official title: A Multicenter, Open-label, Phase 1 Study of the Safety, Tolerability, Systemic Exposure, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam, 0.005%, in Pediatric Subjects (Ages 2 to 11 Years) With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: plaque psoriasis
pediatric
mild
moderate
Lead sponsor: Mayne Pharma International Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2012-04-23
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

* Male or female subjects, ages 2 to 11 years, inclusive, at the time of consent
* For the maximum-use cohort:

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:

* Any inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis
* Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative, or pustular psoriasis
* Use of any topical treatments that have a known beneficial effect on psoriasis, including but not limited to corticosteroids, retinoids, vitamin D derivatives, coal tar, tazarotene, medicated shampoos, or anthralin, within 2 weeks prior to enrollment
* Use of nonbiologic systemic antipsoriatic therapy (eg, corticosteroids, psoralen, retinoids, methotrexate, cyclosporine, other immunosuppressive agents), biologic therapy (eg, adalimumab, etanercept, golimumab, infliximab, ustekinumab), or phototherapy (eg, psoralen and ultraviolet A \[PUVA\], ultraviolet B \[UVB\]) within 4 weeks prior to enrollment
* Use of or need for initiation of any nonpsoriatic therapy that might affect psoriasis (including antimalarials, β-blockers, interferon, or lithium) within 4 weeks prior to enrollment
* Use of medications that affect or change calcium and parathyroid hormone (PTH) concentrations or interfere with the measurement of calcium or PTH concentrations within 4 weeks prior to enrollment
* Known difficult venous access beyond that expected for subject age
* Average daily ingestion of more than 2000 mg of elemental calcium or more than 1000 IU of vitamin D within 2 weeks prior to enrollment
* History of hypersensitivity, known allergy, or other adverse reaction to calcipotriene or other vitamin D analogs or to any component of the study product
* Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
* Use of any investigational therapy within 4 weeks prior to enrollment
* Pregnant or breast feeding female or females who do not use contraception
* Current immunosuppression
* Albumin-adjusted serum calcium at screening that is above the upper limit of normal

Primary outcomes:
measure: Evaluation of treatment effect and change in ISGA scores of body and scalp psoriasis (Safety and Tolerability)
timeFrame: 56 weeks
Secondary outcomes:
measure: Plasma concentrations (trough) of calcipotriene
timeFrame: 8 weeks
measure: Pharmacodynamic effect
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Rogers
country: United States
facility: Investigational Site
state: Arkansas
city: Encino
country: United States
facility: Investigational Site
state: California
city: Fountain Valley
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Sherman Oaks
country: United States
state: California
city: Hollywood
country: United States
facility: Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
facility: Investigational Site
state: Florida
city: Tampa
country: United States
facility: Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Investigational Site
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
facility: Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Plainfield
country: United States
facility: Investigational Site
state: Indiana
city: Brighton
country: United States
state: Massachusetts
city: Farmington Hills
country: United States
facility: Investigational Site
state: Michigan
city: Saint Joseph
country: United States
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site
state: Missouri
city: New York
country: United States
facility: Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Investigational Site
state: Oregon
city: Hershey
country: United States
facility: Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Investigational Site
state: Washington
Study officials:
affiliation: Sponsor GmbH
name: Stuart Mudge
role: STUDY_DIRECTOR
References: