Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582932
• Other study ID #: STF115469
• Status: Completed
• Phase: Phase 1
• Start date: April 2013
• Est. completion date: August 2018

Study information

• Verified date: January 2019
• Source: Mayne Pharma International Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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, ß-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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Calcipotriene 0.005% Foam
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face).

Locations

Country	Name	City	State
United States	Investigational Site	Alpharetta	Georgia
United States	Investigational Site	Austin	Texas
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Chapel Hill	North Carolina
United States	Investigational Site	Chicago	Illinois
United States	Investigational Site	Encino	California
United States	Investigational Site	Farmington Hills	Michigan
United States	Investigational Site	Hershey	Pennsylvania
United States	Investigational Site	Hollywood	Florida
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Jacksonville	Florida
United States	Investigational Site	Marietta	Georgia
United States	Investigational Site	Miami	Florida
United States	Investigational Site	New York	New York
United States	Investigational Site	Norfolk	Virginia
United States	Investigational Site	Plainfield	Indiana
United States	Investigational Site	Portland	Oregon
United States	Investigational Site	Rogers	Arkansas
United States	Investigational Site	Saint Louis	Missouri
United States	Investigational Site	Saint Louis	Missouri
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	Sandy Springs	Georgia
United States	Investigational Site	Spokane	Washington
United States	Investigational Site	Tacoma	Washington
United States	Investigational Site	Tampa	Florida
United States	Investigational Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mayne Pharma International Pty Ltd	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Pharmacodynamic effect	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