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

NCT02970331 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: CLS008-CO-PR-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• Change in incidence and severity of application site adverse events

  screening, weeks 0,2,4 and 8

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

  screening, weeks 0,2,4 and 8

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

  week 8

• 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

• Determination of plasma concentrations of Pefcalcitol and its metabolites

  Day 1 and Day 15

Secondary Outcomes (4)

• 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 success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline

  week 8

• Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline

  week 8

Study Arms (1)

pefcalcitol

EXPERIMENTAL

pefcalcitol 0.005% BID for 8 weeks

Drug: pefcalcitol ointment, 0.005%

Interventions

pefcalcitol ointment, 0.005% DRUG

pefcalcitol ointment, 0.005%

pefcalcitol

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 22, 2016
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 18, 2023

Record last verified: 2019-01