A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis

Maruho Co., Ltd.0 sitesJune 2019

ConditionsPsoriasis

Interventionspefcalcitol ointment, 0.005%

Drugspefcalcitol ointment, 0.005%

Overview

Phase: Phase 2
Intervention: pefcalcitol ointment, 0.005%
Conditions: Psoriasis
Sponsor: Maruho Co., Ltd.
Primary Endpoint: 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)
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2019

End Date

December 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Maruho Co., Ltd.

Responsible Party

Sponsor

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);

Arms & Interventions

pefcalcitol

pefcalcitol 0.005% BID for 8 weeks

Intervention: pefcalcitol ointment, 0.005%

Outcomes

Primary Outcomes

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)

Time Frame: week 8

Determination of plasma concentrations of Pefcalcitol and its metabolites

Time Frame: Day 1 and Day 15

Change in incidence and severity of application site adverse events

Time Frame: screening, weeks 0,2,4 and 8

Changes from baseline (pre-dose, Day 1) in safety laboratory parameters

Time Frame: week 8

Change in incidence and severity of all AEs and their relationship to study drug

Time Frame: screening, weeks 0,2,4 and 8

Secondary Outcomes

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(week 8)
Proportion of subjects who achieved 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)