A Phase 2, Multicenter, Open-label Study to Assess the Sa... | NCT02970331

Status Module

Label	Type	Description	Intervention Names
pefcalcitol	Experimental	pefcalcitol 0.005% BID for 8 weeks	Drug: pefcalcitol ointment, 0.005%

Name	Type	Description	Arm Group Labels	Other Names
pefcalcitol ointment, 0.005%	Drug	pefcalcitol ointment, 0.005%	pefcalcitol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Determination of plasma concentrations of Pefcalcitol and its metabolites		Day 1 and Day 15

Secondary Outcomes

Measure	Description	Time Frame
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
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

Eligibility Module

Eligibility Criteria

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.

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases