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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

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ClinicalTrials.gov Identifier: NCT02970331
Recruitment Status : Not yet recruiting
First Posted : November 22, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: pefcalcitol ointment, 0.005% Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: pefcalcitol
pefcalcitol 0.005% BID for 8 weeks
Drug: pefcalcitol ointment, 0.005%
pefcalcitol ointment, 0.005%




Primary Outcome Measures :
  1. Change in incidence and severity of application site adverse events [ Time Frame: screening, weeks 0,2,4 and 8 ]
  2. Change in incidence and severity of all AEs and their relationship to study drug [ Time Frame: screening, weeks 0,2,4 and 8 ]
  3. Changes from baseline (pre-dose, Day 1) in safety laboratory parameters [ Time Frame: week 8 ]
  4. 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 ]
  5. Determination of plasma concentrations of Pefcalcitol and its metabolites [ Time Frame: Day 1 and Day 15 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline [ Time Frame: week 8 ]


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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT02970331     History of Changes
Other Study ID Numbers: CLS008-CO-PR-001
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases