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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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 12 Years - 16 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02970331
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Maruho Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Arms & Interventions

Arms

Experimental: pefcalcitol

pefcalcitol 0.005% BID for 8 weeks

Interventions

Drug: - pefcalcitol ointment, 0.005%

pefcalcitol ointment, 0.005%

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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