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

Status and phase

Withdrawn

Phase 2

Conditions

Psoriasis

Treatments

Drug: pefcalcitol ointment, 0.005%

Study type

Interventional

Funder types

Industry

Identifiers

NCT02970331

CLS008-CO-PR-001

Details and patient eligibility

About

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.

Sex

All

Ages

12 to 16 years old

Volunteers

No Healthy Volunteers

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.