Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s

Overview

The objective of this phase III study is to evaluate the efficacy, systemic safety and local tolerability of P-3073 (calcipotriene 0.005%) nail solution in patients with mild to moderate psoriatic fingernail/s.

Full Title of Study: “A Randomized, Doubleblind, Vehicle-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2018

Detailed Description

This phase III study versus vehicle will be conducted to confirm the clinical efficacy and safety of P-3073 in patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and concomitant mild-to-moderate plaque psoriasis.

The evaluation of the primary endpoint will be made using the Nail Psoriasis Severity Index (NAPSI).

The secondary objectives will be:

- To assess if the topical treatment with P-3073 is able to improve the quality of life and discomfort in patients with psoriatic fingernail.

- To assess the safety and tolerability of topical P-3073 in the treatment of psoriatic fingernail.

The study consists of two arms comparing P-3073 (calcipotriene 0.005%) and vehicle. Eligible patients will be randomized to either P-3073 or placebo in a 1:1 ratio, stratified by their target nail NAPSI severity at screening.

The study population will include at least 470 patients (235 for each group) with nail psoriasis (fingernails) of the matrix and/or of the nail bed in at least one fingernail.

The total duration of the trial for each patient will be approximately 29 weeks (from Screening to Follow-up). During the 24 weeks of the treatment period, patients will apply the assigned treatment to all affected psoriatic fingernails once daily.

Interventions

  • Drug: P-3073 (calcipotriene 0.005%)
    • Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.
  • Drug: Vehicle of P-3073
    • Once daily for 24 weeks.

Arms, Groups and Cohorts

  • Experimental: P-3073
  • Placebo Comparator: Vehicle

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with clear target nail at Week 24
    • Time Frame: Week 24
    • Defined as Nail Psoriasis Severity Index (NAPSI) =0

Secondary Measures

  • Proportion of affected nails at baseline with NAPSI=0 at Week 24
    • Time Frame: Baseline – Week 24
    • Defined as affected nails with NAPSI=0
  • Proportion of patients with clear target nail bed at Week 24
    • Time Frame: Baseline – Week 24
    • Defined as nail bed in NAPSI=0
  • Proportion of patients with clear target nail matrix at Week 24
    • Time Frame: Baseline – Week 24
    • Defined as nail matrix in NAPSI=0

Participating in This Clinical Trial

Inclusion Criteria

  • Written informed consent before starting any study related procedure.
  • Patients ages ≥ 18 and ≤ 80 years old.
  • Men or women.
  • Outpatients.
  • Patients with mild to moderate psoriatic fingernail/s, defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline. The sum of the scores for each nail should range between 1 and 6.
  • In case of skin involvement, patients with established clinical diagnosis of mild to moderate psoriasis (BSA involvement ≤ 8% or Psoriasis Area Severity Index (PASI) ≤ 10).

Exclusion Criteria

  • Use of any systemic treatment for psoriasis and/or nail psoriasis during the last six months before the screening visit.
  • Use of any topical treatment for nail psoriasis on fingernails during the last six months before the screening visit.
  • Use of photochemotherapy (phototherapy is allowed) or other forms of radiotherapy during the last four weeks before the screening visit.
  • Positive mycology findings (KOH evaluation or culture) obtained in the three months before the screening visit or positive KOH evaluated at the screening visit.
  • Patients using nail polish or other nail cosmetic products during last 72 hours prior to study drug application.
  • Systemic use of the following therapies for any reason during last three months before the screening visit: immunosuppressives, chemotherapy and corticosteroids (topical use for plaque psoriasis is allowed).
  • Consumption of oral Vitamin D or its analogues for any reason during the last three months before the screening visit (Calcipotriene topical use for plaque psoriasis is allowed).
  • Patients with a clinically significant history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction. A clinically significant disease is defined as one that in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease that may influence the results of the study or the patient's ability to participate in the study.
  • Patients with a recent history (< 1 year) of myocardial infarction and/or (< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
  • History of hypercalcaemia or hypercalciuria.
  • History of previous or current malignancy in particular lymphoma, melanoma and/or basal cell carcinoma.
  • History of allergic reactions to Calcipotriene or P-3073 excipients.
  • Patients unable to understand the procedures and purposes of the study.
  • Patients unable or unwilling to accept and meet study requirements.
  • Use of an investigational drug or participation in an investigational study within 30 days, or 6 half lives whichever is longer, prior to application of study medication.
  • Alcohol or substance abuse.
  • AIDS symptoms or any other immunodeficiency.

Additional exclusion criteria for females only:

  • Breast-feeding patients.
  • Positive urine pregnancy test at screening (performed for all females of child bearing potential or for those in non-surgical post-menopause for less than 1 year).
  • Female of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e., a male who has not been sterilized by vasectomy at least 6 months prior to drug application) within 14 days prior to study drug application. Acceptable methods of contraception are the following: condom, diaphragm, intrauterine contraceptive device (placed at least 4 weeks prior to study drug application), pill + condom.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Polichem S.A.
  • Collaborator
    • Almirall, S.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maurizio Caserini, MD, Study Director, Polichem SA

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