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

NCT ID: NCT02970331

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2019-12-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pefcalcitol

pefcalcitol 0.005% BID for 8 weeks

Group Type: EXPERIMENTAL

pefcalcitol ointment, 0.005%

Intervention Type: DRUG

pefcalcitol ointment, 0.005%

Interventions

pefcalcitol ointment, 0.005%

pefcalcitol ointment, 0.005%

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maruho Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CLS008-CO-PR-001

Identifier Type: -

Identifier Source: org_study_id