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

NCT ID: NCT03079973

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2018-07-31

Brief Summary

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.

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.

Conditions

Nail Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

P-3073

Group Type: EXPERIMENTAL

P-3073 (calcipotriene 0.005%)

Intervention Type: DRUG

Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.

Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle of P-3073

Intervention Type: DRUG

Once daily for 24 weeks.

Interventions

P-3073 (calcipotriene 0.005%)

Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.

Intervention Type: DRUG

Vehicle of P-3073

Once daily for 24 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall, S.A.

INDUSTRY

Sponsor Role: collaborator

Polichem S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurizio Caserini, MD

Role: STUDY_DIRECTOR

Polichem SA

Locations

Polichem Investigation Site no 47

Birmingham, Alabama, United States

Polichem Investigation Site no 21

Phoenix, Arizona, United States

Polichem Investigation Site no 11

Little Rock, Arkansas, United States

Polichem Investigation Site no 45

North Hollywood, California, United States

Polichem Investigation Site no 39

San Diego, California, United States

Polichem Investigation Site no 56

Santa Monica, California, United States

Polichem Investigation Site no 18

Washington D.C., District of Columbia, United States

Polichem Investigation Site no 36

Clearwater, Florida, United States

Polichem Investigation Site no 10

Miami, Florida, United States

Polichem Investigation Site no 38

Miami, Florida, United States

Polichem Investigation Site no 13

Miami, Florida, United States

Polichem Investigation Site no 20

Miami Lakes, Florida, United States

Polichem Investigation Site no 17

Ocala, Florida, United States

Polichem Investigation Site no 35

Ormond Beach, Florida, United States

Polichem Investigation site no 1

Tampa, Florida, United States

Polichem Investigation Site no 24

Tampa, Florida, United States

Polichem Investigation Site no 28

Tampa, Florida, United States

Polichem Investigation Site no 25

Columbus, Georgia, United States

Polichem Investigation Site no 23

Skokie, Illinois, United States

Polichem Investigation Site no 29

West Dundee, Illinois, United States

Polichem Investigation Site no 16

New Albany, Indiana, United States

Polichem Investigation site no 3

West Des Moines, Iowa, United States

Polichem Investigation Site no 22

Overland Park, Kansas, United States

Polichem Investigation Site no 52

Louisville, Kentucky, United States

Polichem Investigation Site no 19

Louisville, Kentucky, United States

Polichem Investigation Site no 49

New Orleans, Louisiana, United States

Polichem Investigation Site no 32

New Orleans, Louisiana, United States

Polichem Investigation Site no 34

Rockville, Maryland, United States

Polichem Investigation Site no 31

Ann Arbor, Michigan, United States

Polichem Investigation Site no 2

Bay City, Michigan, United States

Polichem Investigation Site no 9

Fridley, Minnesota, United States

Polichem Investigation Site no 6

Omaha, Nebraska, United States

Polichem Investigation Site no 5

Las Vegas, Nevada, United States

Polichem Investigation Site no 41

Portsmouth, New Hampshire, United States

Polichem Investigation Site no 58

East Windsor, New Jersey, United States

Polichem Investigation Site no 54

Buffalo, New York, United States

Polichem Investigation Site no 37

New York, New York, United States

Polichem Investigation Site no 4

Rochester, New York, United States

Polichem Investigation Site no 48

Rochester, New York, United States

Polichem Investigation Site no 46

High Point, North Carolina, United States

Polichem Investigation Site no 27

Winston-Salem, North Carolina, United States

Polichem Investigation Site no 44

Cincinnati, Ohio, United States

Polichem Investigation Site no 40

Norman, Oklahoma, United States

Polichem Investigation Site no 14

Portland, Oregon, United States

Polichem Investigation Site no 51

Johnston, Rhode Island, United States

Polichem Investigation Site no 8

Charleston, South Carolina, United States

Polichem Investigation Site no 26

Rapid City, South Dakota, United States

Polichem Investigation Site no 12

Goodlettsville, Tennessee, United States

Polichem Investigation Site no 7

Knoxville, Tennessee, United States

Polichem Investigation Site no 56

Arlington, Texas, United States

Polichem Investigation Site no 43

Dallas, Texas, United States

Polichem Investigation Site no 42

Pflugerville, Texas, United States

Polichem Investigation Site no 33

San Antonio, Texas, United States

Polichem Investigation Site no 53

San Antonio, Texas, United States

Polichem Investigation Site no 55

San Antonio, Texas, United States

Polichem Investigation Site no 50

Murray, Utah, United States

Polichem Investigation Site no 15

Norfolk, Virginia, United States

Polichem Investigation Site no 30

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PM1440

Identifier Type: -

Identifier Source: org_study_id

NCT03209388

Identifier Type: -

Identifier Source: nct_alias