To Evaluate the Safety, Tolerability and Efficacy of Calcipotriene Foam, 0.005%, Versus Vehicle Foam in Pediatric Subjects (Ages 2-11) With Plaque Psoriasis

This study is currently recruiting participants.
Verified January 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01582932
First received: March 29, 2012
Last updated: March 27, 2014
Last verified: January 2014

March 29, 2012
March 27, 2014
April 2013
April 2019   (final data collection date for primary outcome measure)
treatment success [ Time Frame: week 8 ] [ Designated as safety issue: No ]
Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from baseline to week 8.
treatment success [ Time Frame: week 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01582932 on ClinicalTrials.gov Archive Site
  • erythema [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Target lesion score of 0 or 1 and at least a 2-grade improvement from baseline
  • scaling [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Target lesion score of 0 or 1 and at least a 2-grade improvement from baseline
  • plaque thickness [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Target lesion score of 0 or 1
  • erythema [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • scaling [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • plaque thickness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
To Evaluate the Safety, Tolerability and Efficacy of Calcipotriene Foam, 0.005%, Versus Vehicle Foam in Pediatric Subjects (Ages 2-11) With Plaque Psoriasis
A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety, Efficacy, Systemic Exposure, and Pharmacodynamics of Calcipotriene Foam, 0.005%, Versus Vehicle Foam in Pediatric Subjects (Ages 2 to 11 Years) With Plaque Psoriasis

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 comparing calcipotriene foam, 0.005% with vehicle foam 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, randomized, double-blind, Phase 3 study comparing calcipotriene foam, 0.005%, with vehicle foam in pediatric subjects, ages 2 to 11 years, inclusive, with mild to moderate plaque psoriasis. Subjects will be required to have plaque psoriasis affecting at least 5% body surface area (BSA) involvement on the body and at least 5% scalp involvement (excluding the face) with an Investigator Static Global Assessment ( ISGA) score of mild to moderate (score of 2 or 3) at baseline. In addition, a minimum of 75 subjects will have at least 10% BSA on the body (excluding the face and scalp) and a minimum of 10% scalp involvement (excluding the face) with an ISGA score of moderate. Subjects must have a target lesion >2 cm2 on the trunk or extremities (excluding palms/soles, knees, elbows, scalp, and intertriginous areas) with a score of 2 or 3 for erythema, scaling, and plaque thickness. Approximately 180 subjects will be enrolled and dosed twice daily for 8 weeks. Subjects will be randomly assigned to 1 of 2 treatment groups in a 2:1 ratio (calcipotriene foam, 0.005%: vehicle foam).

Study Duration, up to 2 weeks in screening, 8 weeks of treatment and a phone call at Week 9 or 1 week after an early termination visit (approximately 77 days total in study).

Blood samples for the evaluation of albumin-adjusted serum calcium, intact PTH (iPTH), alkaline phosphatase, magnesium, and phosphorus will be collected at screening, baseline (predose), and 1 to 9 hours after application of the morning dose for the Weeks 2 and 8 visits. Blood samples will be collected before dosing at baseline and 1 to 9 hours after dosing at Weeks 2 and 8 for evaluation of calcipotriene plasma concentrations. Urine for the evaluation of calcium/creatinine ratio will be collected at baseline (predose), and 1 to 9 hours after application of the morning dose for the Weeks 2 and 8 visits.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Psoriasis
  • Drug: STF 115469 Foam
    All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face).
    Other Name: calcipotriene
  • Drug: Vehicle Foam
    All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face).
    Other Name: vehicle
  • Experimental: STF 115469 Foam
    Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions (except the face).
    Intervention: Drug: STF 115469 Foam
  • Placebo Comparator: Vehicle Foam
    Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriatic lesions (except the face).
    Intervention: Drug: Vehicle Foam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
April 2019
April 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects, ages 2 to 11 years, inclusive, at the time of consent
  • Clinical diagnosis of mild to moderate plaque psoriasis, as defined by body ISGA score of 2 or 3 on a scale of 0 to 4.
  • Mild to moderate plaque psoriasis involving at least 5% BSA and at least 5% scalp involvement (excluding the face).
  • Identification of a target lesion (>2 cm2) on the trunk or extremities with a score of 2 or 3 on a 0 to 5 scale for erythema, scaling, and plaque thickness

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 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
Both
2 Years to 11 Years
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
United States
 
NCT01582932
115469
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP