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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. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01582932
First received: March 29, 2012
Last updated: October 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: STF 115469 Foam
Drug: Vehicle Foam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 180
Study Start Date: April 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
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).
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582932

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 25 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01582932     History of Changes
Other Study ID Numbers: 115469
Study First Received: March 29, 2012
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Calcipotriene
Calcitriol
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Dermatologic Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on November 27, 2014