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 P

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cutanea Life Sciences, Inc.; Maruho Co., Ltd.

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/immunomodulative 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.