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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Nail Psoriasis
• Intervention / Treatment: Drug: P-3073 (calcipotriene 0.005%); Drug: Vehicle of P-3073

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Polichem Investigation Site no 47
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Polichem Investigation Site no 21
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Polichem Investigation Site no 11
  • California
    • North Hollywood, California, United States, 91606
      • Polichem Investigation Site no 45
    • San Diego, California, United States, 92123
      • Polichem Investigation Site no 39
    • Santa Monica, California, United States, 90404
      • Polichem Investigation Site no 56
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Polichem Investigation Site no 18
  • Florida
    • Clearwater, Florida, United States, 33757
      • Polichem Investigation Site no 36
    • Miami, Florida, United States, 33134
      • Polichem Investigation Site no 10
    • Miami, Florida, United States, 33136
      • Polichem Investigation Site no 38
    • Miami, Florida, United States, 33175
      • Polichem Investigation Site no 13
    • Miami Lakes, Florida, United States, 33016
      • Polichem Investigation Site no 20
    • Ocala, Florida, United States, 34471
      • Polichem Investigation Site no 17
    • Ormond Beach, Florida, United States, 32174
      • Polichem Investigation Site no 35
    • Tampa, Florida, United States, 33607
      • Polichem Investigation site no 1
    • Tampa, Florida, United States, 33612
      • Polichem Investigation Site no 24
    • Tampa, Florida, United States, 33624
      • Polichem Investigation Site no 28
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Polichem Investigation Site no 25
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Polichem Investigation Site no 23
    • West Dundee, Illinois, United States, 60118
      • Polichem Investigation Site no 29
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Polichem Investigation Site no 16
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Polichem Investigation site no 3
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Polichem Investigation Site no 22
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Polichem Investigation Site no 52
    • Louisville, Kentucky, United States, 40241
      • Polichem Investigation Site no 19
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Polichem Investigation Site no 49
    • New Orleans, Louisiana, United States, 70115
      • Polichem Investigation Site no 32
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Polichem Investigation Site no 34
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Polichem Investigation Site no 31
    • Bay City, Michigan, United States, 47706
      • Polichem Investigation Site no 2
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Polichem Investigation Site no 9
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Polichem Investigation Site no 6
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Polichem Investigation Site no 5
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Polichem Investigation Site no 41
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Polichem Investigation Site no 58
  • New York
    • Buffalo, New York, United States, 14221
      • Polichem Investigation Site no 54
    • New York, New York, United States, 10029
      • Polichem Investigation Site no 37
    • Rochester, New York, United States, 14609
      • Polichem Investigation Site no 4
    • Rochester, New York, United States, 14623
      • Polichem Investigation Site no 48
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Polichem Investigation Site no 46
    • Winston-Salem, North Carolina, United States, 27104
      • Polichem Investigation Site no 27
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Polichem Investigation Site no 44
  • Oklahoma
    • Norman, Oklahoma, United States, 71071
      • Polichem Investigation Site no 40
  • Oregon
    • Portland, Oregon, United States, 97239
      • Polichem Investigation Site no 14
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Polichem Investigation Site no 51
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Polichem Investigation Site no 8
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Polichem Investigation Site no 26
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Polichem Investigation Site no 12
    • Knoxville, Tennessee, United States, 37922
      • Polichem Investigation Site no 7
  • Texas
    • Arlington, Texas, United States, 76011
      • Polichem Investigation Site no 56
    • Dallas, Texas, United States, 75246
      • Polichem Investigation Site no 43
    • Pflugerville, Texas, United States, 78660
      • Polichem Investigation Site no 42
    • San Antonio, Texas, United States, 78229
      • Polichem Investigation Site no 53
    • San Antonio, Texas, United States, 78213
      • Polichem Investigation Site no 33
    • San Antonio, Texas, United States, 78249
      • Polichem Investigation Site no 55
  • Utah
    • Murray, Utah, United States, 84107
      • Polichem Investigation Site no 50
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Polichem Investigation Site no 15
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Polichem Investigation Site no 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: P-3073	Drug: P-3073 (calcipotriene 0.005%); Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.
PLACEBO_COMPARATOR: Vehicle	Drug: Vehicle of P-3073; Once daily for 24 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of affected nails at baseline with NAPSI=0 at Week 24	Defined as affected nails with NAPSI=0	Baseline - Week 24
Proportion of patients with clear target nail bed at Week 24	Defined as nail bed in NAPSI=0	Baseline - Week 24
Proportion of patients with clear target nail matrix at Week 24	Defined as nail matrix in NAPSI=0	Baseline - Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with target nail reaching NAPSI-75%	Defined as a reduction of ≥75% from baseline NAPSI score	Baseline - Week 24
Proportion of affected nails at baseline reaching NAPSI-75%	Defined as a reduction of ≥75% from baseline NAPSI score	Baseline - Week 24
Change from Baseline in Total NAPSI at Week 24	Defined as change in Nail Psoriasis Severity Index	Baseline - Week 24
Time to reach NAPSI=0 in the target nail	Defined as time until NAPSI=0	Up to Week 24
Proportion of affected nails at baseline becoming nail Physician Global Assessment (PGA) responder at Week 24	Defined as Nail PGA response rate	Baseline - Week 24
Change from Baseline in Nail Psoriasis Visual Analogue Scale (VAS) Discomfort at Week 24	Defined as change in VAS	Baseline - Week 24
Patient Acceptance of Study Therapy at Week 24	Note: Missing values will be replaced with the worst score	Baseline - Week 24
Change from Baseline in EuroQoL-5Dimensions-5Levels (EQ-5D-5L) at Week 24	Defined as change in EQ-5D-5L	Baseline - Week 24
Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 24	Defined as change in DLQI	Baseline - Week 24
Change from Baseline in Short Form 36 Health Survey (SF-36) at Week 24	Defined as change in SF-36	Baseline - Week 24
Change from Baseline in Nail Psoriasis Quality of Life Index (NPQ10) at Week 24	Defined as change in NPQ10	Baseline - Week 24

Collaborators and Investigators

• Sponsor: Polichem S.A.
• Collaborators: Almirall, S.A.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 15, 2017
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (ACTUAL): March 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Calcipotriene
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Calcipotriene
• Other Study ID Numbers: PM1440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No