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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02970331
• Other study ID #: CLS008-CO-PR-001
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2019
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Maruho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• pefcalcitol ointment, 0.005%
pefcalcitol ointment, 0.005%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maruho Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in incidence and severity of application site adverse events		screening, weeks 0,2,4 and 8
Primary	Change in incidence and severity of all AEs and their relationship to study drug		screening, weeks 0,2,4 and 8
Primary	Changes from baseline (pre-dose, Day 1) in safety laboratory parameters		week 8
Primary	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
Primary	Determination of plasma concentrations of Pefcalcitol and its metabolites		Day 1 and Day 15
Secondary	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
Secondary	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
Secondary	Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline		week 8
Secondary	Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline		week 8