Psoriasis
Conditions
Brief summary
A multi-center, open-label study that will evaluate the safety/tolerability and pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50 evaluable adolescents 12 to \< 17 years of age.
Interventions
DRUGpefcalcitol ointment, 0.005%
pefcalcitol ointment, 0.005%
Sponsors
Maruho Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* male or females 12 to \< 17 years of age * Have a confirmed diagnosis of plaque psoriasis * Negative pregnancy test * Group 1: Have plaque psoriasis with an IGA score of ≥ 2 (mild), with at least one lesion ) and up to 20% Body Surface Area (BSA) involvement not including psoriasis on the face and scalp * Group 2: Have plaque psoriasis with a IGA score of ≥ 2 (mild), with plaque psoriasis involving at least 10% and up to 20% Body Surface Area (BSA) not including psoriasis on the face and scalp
Exclusion criteria
* known allergy or intolerance to the study drug or other vitamin D3 analogs or any of its components * history of or active generalized guttate, pustular or erythrodermic exfoliative psoriasis * history or presence of contact dermatitis induced by a topical medicine or other serious skin condition that is not well controlled * Use topical treatments known to have beneficial effects on psoriasis * Use phototherapy, oral corticosteroids, oral retinoid, oral immunosuppressive/immunomodulate drugs, cytostatics, cyclosporine or methotrexate within 30 days prior to the first dose of study drug * Use any approved biologics for psoriasis within 30 days or 5 half-lives of the biologic before the first dose of study drug * Are treated with medications known to worsen psoriasis * Are taking an oral vitamin D * Are taking medications that affect calcium metabolism; * Subjects who have an average of three (3) QTcF measurements of \> 450 milliseconds as shown on the ECG (Group 2 only); * Have clinically significant abnormal calcium homeostasis parameters at Visit 1; * Have clinically significant liver or renal dysfunction * Have any other clinically significant laboratory abnormalities, co-morbidities or psychiatric conditions which that would place the subject at increased risk or would confound the primary or secondary objectives of the study; * Use of any investigational drugs or biologics and/or participated in any clinical trial within the last 60 days before the day of the first dose of study drug or are taking part in a non-medication study which, that would interfere with study compliance or outcome assessments; * Are pregnant or lactating females; * Have a known history of congenital or acquired immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of plasma concentrations of Pefcalcitol and its metabolites | Day 1 and Day 15 |
| Change in incidence and severity of application site adverse events | screening, weeks 0,2,4 and 8 |
| Change in incidence and severity of all AEs and their relationship to study drug | screening, weeks 0,2,4 and 8 |
| Changes from baseline (pre-dose, Day 1) in safety laboratory parameters | week 8 |
| Changes from baseline (pre-dose, Day 1) in calcium homeostasis parameters (total serum calcium and albumin-corrected calcium levels, plasma parathyroid hormone (PTH), and serum alkaline phosphatase) | week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieved an mPASI 75 from baseline (Week 0) to Week 8, or who achieved an mPASI 50 and a 5-point improvement in the CDLQI from baseline | week 8 |
| Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline | week 8 |
| Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline | week 8 |
| Proportion of subjects with an IGA score of absence (0) or very mild (1) with a minimum of a 2-grade improvement from baseline | week 8 |
Outcome results
None listed