Clinical trial NCT03079973: Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s
Official title: 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: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Nail Psoriasis
Keywords: Calcipotriene
Lead sponsor: Polichem S.A.
Sponsor class: INDUSTRY
Collaborators: name: Almirall, S.A.
First posted: 2017-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Proportion of patients with clear target nail at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of affected nails at baseline with NAPSI=0 at Week 24
timeFrame: Baseline - Week 24
measure: Proportion of patients with clear target nail bed at Week 24
timeFrame: Baseline - Week 24
measure: Proportion of patients with clear target nail matrix at Week 24
timeFrame: Baseline - Week 24
Other outcomes:
measure: Proportion of patients with target nail reaching NAPSI-75%
timeFrame: Baseline - Week 24
measure: Proportion of affected nails at baseline reaching NAPSI-75%
timeFrame: Baseline - Week 24
measure: Change from Baseline in Total NAPSI at Week 24
timeFrame: Baseline - Week 24
measure: Time to reach NAPSI=0 in the target nail
timeFrame: Up to Week 24
measure: Proportion of affected nails at baseline becoming nail Physician Global Assessment (PGA) responder at Week 24
timeFrame: Baseline - Week 24
measure: Change from Baseline in Nail Psoriasis Visual Analogue Scale (VAS) Discomfort at Week 24
timeFrame: Baseline - Week 24
measure: Patient Acceptance of Study Therapy at Week 24
timeFrame: Baseline - Week 24
measure: Change from Baseline in EuroQoL-5Dimensions-5Levels (EQ-5D-5L) at Week 24
timeFrame: Baseline - Week 24
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 24
timeFrame: Baseline - Week 24
measure: Change from Baseline in Short Form 36 Health Survey (SF-36) at Week 24
timeFrame: Baseline - Week 24
measure: Change from Baseline in Nail Psoriasis Quality of Life Index (NPQ10) at Week 24
timeFrame: Baseline - Week 24
Locations:
city: Birmingham
country: United States
facility: Polichem Investigation Site no 47
state: Alabama
city: Phoenix
country: United States
facility: Polichem Investigation Site no 21
state: Arizona
city: Little Rock
country: United States
facility: Polichem Investigation Site no 11
state: Arkansas
city: North Hollywood
country: United States
facility: Polichem Investigation Site no 45
state: California
city: San Diego
country: United States
facility: Polichem Investigation Site no 39
state: California
city: Santa Monica
country: United States
facility: Polichem Investigation Site no 56
state: California
city: Washington
country: United States
facility: Polichem Investigation Site no 18
state: District of Columbia
city: Clearwater
country: United States
facility: Polichem Investigation Site no 36
state: Florida
city: Miami Lakes
country: United States
facility: Polichem Investigation Site no 20
state: Florida
city: Miami
country: United States
facility: Polichem Investigation Site no 10
state: Florida
city: Miami
country: United States
facility: Polichem Investigation Site no 38
state: Florida
city: Miami
country: United States
facility: Polichem Investigation Site no 13
state: Florida
city: Ocala
country: United States
facility: Polichem Investigation Site no 17
state: Florida
city: Ormond Beach
country: United States
facility: Polichem Investigation Site no 35
state: Florida
city: Tampa
country: United States
facility: Polichem Investigation site no 1
state: Florida
city: Tampa
country: United States
facility: Polichem Investigation Site no 24
state: Florida
city: Tampa
country: United States
facility: Polichem Investigation Site no 28
state: Florida
city: Columbus
country: United States
facility: Polichem Investigation Site no 25
state: Georgia
city: Skokie
country: United States
facility: Polichem Investigation Site no 23
state: Illinois
city: West Dundee
country: United States
facility: Polichem Investigation Site no 29
state: Illinois
city: New Albany
country: United States
facility: Polichem Investigation Site no 16
state: Indiana
city: West Des Moines
country: United States
facility: Polichem Investigation site no 3
state: Iowa
city: Overland Park
country: United States
facility: Polichem Investigation Site no 22
state: Kansas
city: Louisville
country: United States
facility: Polichem Investigation Site no 52
state: Kentucky
city: Louisville
country: United States
facility: Polichem Investigation Site no 19
state: Kentucky
city: New Orleans
country: United States
facility: Polichem Investigation Site no 49
state: Louisiana
city: New Orleans
country: United States
facility: Polichem Investigation Site no 32
state: Louisiana
city: Rockville
country: United States
facility: Polichem Investigation Site no 34
state: Maryland
city: Ann Arbor
country: United States
facility: Polichem Investigation Site no 31
state: Michigan
city: Bay City
country: United States
facility: Polichem Investigation Site no 2
state: Michigan
city: Fridley
country: United States
facility: Polichem Investigation Site no 9
state: Minnesota
city: Omaha
country: United States
facility: Polichem Investigation Site no 6
state: Nebraska
city: Las Vegas
country: United States
facility: Polichem Investigation Site no 5
state: Nevada
city: Portsmouth
country: United States
facility: Polichem Investigation Site no 41
state: New Hampshire
city: East Windsor
country: United States
facility: Polichem Investigation Site no 58
state: New Jersey
city: Buffalo
country: United States
facility: Polichem Investigation Site no 54
state: New York
city: New York
country: United States
facility: Polichem Investigation Site no 37
state: New York
city: Rochester
country: United States
facility: Polichem Investigation Site no 4
state: New York
city: Rochester
country: United States
facility: Polichem Investigation Site no 48
state: New York
city: High Point
country: United States
facility: Polichem Investigation Site no 46
state: North Carolina
city: Winston-Salem
country: United States
facility: Polichem Investigation Site no 27
state: North Carolina
city: Cincinnati
country: United States
facility: Polichem Investigation Site no 44
state: Ohio
city: Norman
country: United States
facility: Polichem Investigation Site no 40
state: Oklahoma
city: Portland
country: United States
facility: Polichem Investigation Site no 14
state: Oregon
city: Johnston
country: United States
facility: Polichem Investigation Site no 51
state: Rhode Island
city: Charleston
country: United States
facility: Polichem Investigation Site no 8
state: South Carolina
city: Rapid City
country: United States
facility: Polichem Investigation Site no 26
state: South Dakota
city: Goodlettsville
country: United States
facility: Polichem Investigation Site no 12
state: Tennessee
city: Knoxville
country: United States
facility: Polichem Investigation Site no 7
state: Tennessee
city: Arlington
country: United States
facility: Polichem Investigation Site no 56
state: Texas
city: Dallas
country: United States
facility: Polichem Investigation Site no 43
state: Texas
city: Pflugerville
country: United States
facility: Polichem Investigation Site no 42
state: Texas
city: San Antonio
country: United States
facility: Polichem Investigation Site no 33
state: Texas
city: San Antonio
country: United States
facility: Polichem Investigation Site no 53
state: Texas
city: San Antonio
country: United States
facility: Polichem Investigation Site no 55
state: Texas
city: Murray
country: United States
facility: Polichem Investigation Site no 50
state: Utah
city: Norfolk
country: United States
facility: Polichem Investigation Site no 15
state: Virginia
city: Milwaukee
country: United States
facility: Polichem Investigation Site no 30
state: Wisconsin
Study officials:
affiliation: Polichem SA
name: Maurizio Caserini, MD
role: STUDY_DIRECTOR
References: