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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

Primary Purpose

Psoriasis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

pefcalcitol ointment, 0.005%

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept 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/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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pefcalcitol

Arm Description

pefcalcitol 0.005% BID for 8 weeks

Outcomes

Primary Outcome Measures

Change in incidence and severity of application site adverse events

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

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

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)

Determination of plasma concentrations of Pefcalcitol and its metabolites

Secondary Outcome Measures

Proportion of subjects with an IGA score of absence (0) or very mild (1) with a minimum of a 2-grade improvement from baseline

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

Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline

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

Full Information

NCT ID

NCT02970331

First Posted

November 16, 2016

Last Updated

April 13, 2023

Sponsor

Maruho Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02970331

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Withdrawn

Why Stopped

FDA requested us to stop the study

Study Start Date

June 2019 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maruho Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pefcalcitol

Arm Type

Experimental

Arm Description

pefcalcitol 0.005% BID for 8 weeks

Intervention Type

Drug

Intervention Name(s)

pefcalcitol ointment, 0.005%

Intervention Description

pefcalcitol ointment, 0.005%

Primary Outcome Measure Information:

Title

Change in incidence and severity of application site adverse events

Time Frame

screening, weeks 0,2,4 and 8

Title

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

Time Frame

screening, weeks 0,2,4 and 8

Title

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

Time Frame

week 8

Title

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)

Time Frame

week 8

Title

Determination of plasma concentrations of Pefcalcitol and its metabolites

Time Frame

Day 1 and Day 15

Secondary Outcome Measure Information:

Title

Proportion of subjects with an IGA score of absence (0) or very mild (1) with a minimum of a 2-grade improvement from baseline

Time Frame

week 8

Title

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

Time Frame

week 8

Title

Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline

Time Frame

week 8

Title

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

Time Frame

week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

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