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

NCT03079973 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: PM1440
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 58

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.

Conditions

Nail Psoriasis

Keywords

Calcipotriene

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with clear target nail at Week 24

  Defined as Nail Psoriasis Severity Index (NAPSI) =0

  Week 24

Secondary Outcomes (3)

• Proportion of affected nails at baseline with NAPSI=0 at Week 24

  Baseline - Week 24

• Proportion of patients with clear target nail bed at Week 24

  Baseline - Week 24

• Proportion of patients with clear target nail matrix at Week 24

  Baseline - Week 24

Other Outcomes (11)

• Proportion of patients with target nail reaching NAPSI-75%

  Baseline - Week 24

• Proportion of affected nails at baseline reaching NAPSI-75%

  Baseline - Week 24

• Change from Baseline in Total NAPSI at Week 24

  Baseline - Week 24

Study Arms (2)

P-3073

EXPERIMENTAL

Drug: P-3073 (calcipotriene 0.005%)

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle of P-3073

Interventions

P-3073 (calcipotriene 0.005%) DRUG

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

P-3073

Vehicle of P-3073 DRUG

Once daily for 24 weeks.

Vehicle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polichem S.A.: lead
• Almirall, S.A.: collaborator

Study Sites (58)

Polichem Investigation Site no 47

Birmingham, Alabama, 35233, United States

Location

Polichem Investigation Site no 21

Phoenix, Arizona, 85032, United States

Location

Polichem Investigation Site no 11

Little Rock, Arkansas, 72204, United States

Location

Polichem Investigation Site no 45

North Hollywood, California, 91606, United States

Location

Polichem Investigation Site no 39

San Diego, California, 92123, United States

Location

Polichem Investigation Site no 56

Santa Monica, California, 90404, United States

Location

Polichem Investigation Site no 18

Washington D.C., District of Columbia, 20037, United States

Location

Polichem Investigation Site no 36

Clearwater, Florida, 33757, United States

Location

Polichem Investigation Site no 10

Miami, Florida, 33134, United States

Location

Polichem Investigation Site no 38

Miami, Florida, 33136, United States

Location

Polichem Investigation Site no 13

Miami, Florida, 33175, United States

Location

Polichem Investigation Site no 20

Miami Lakes, Florida, 33016, United States

Location

Polichem Investigation Site no 17

Ocala, Florida, 34471, United States

Location

Polichem Investigation Site no 35

Ormond Beach, Florida, 32174, United States

Location

Polichem Investigation site no 1

Tampa, Florida, 33607, United States

Location

Polichem Investigation Site no 24

Tampa, Florida, 33612, United States

Location

Polichem Investigation Site no 28

Tampa, Florida, 33624, United States

Location

Polichem Investigation Site no 25

Columbus, Georgia, 31904, United States

Location

Polichem Investigation Site no 23

Skokie, Illinois, 60077, United States

Location

Polichem Investigation Site no 29

West Dundee, Illinois, 60118, United States

Location

Polichem Investigation Site no 16

New Albany, Indiana, 47150, United States

Location

Polichem Investigation site no 3

West Des Moines, Iowa, 50265, United States

Location

Polichem Investigation Site no 22

Overland Park, Kansas, 66215, United States

Location

Polichem Investigation Site no 52

Louisville, Kentucky, 40202, United States

Location

Polichem Investigation Site no 19

Louisville, Kentucky, 40241, United States

Location

Polichem Investigation Site no 49

New Orleans, Louisiana, 70112, United States

Location

Polichem Investigation Site no 32

New Orleans, Louisiana, 70115, United States

Location

Polichem Investigation Site no 34

Rockville, Maryland, 20850, United States

Location

Polichem Investigation Site no 31

Ann Arbor, Michigan, 48109, United States

Location

Polichem Investigation Site no 2

Bay City, Michigan, 47706, United States

Location

Polichem Investigation Site no 9

Fridley, Minnesota, 55432, United States

Location

Polichem Investigation Site no 6

Omaha, Nebraska, 68134, United States

Location

Polichem Investigation Site no 5

Las Vegas, Nevada, 89148, United States

Location

Polichem Investigation Site no 41

Portsmouth, New Hampshire, 03801, United States

Location

Polichem Investigation Site no 58

East Windsor, New Jersey, 08520, United States

Location

Polichem Investigation Site no 54

Buffalo, New York, 14221, United States

Location

Polichem Investigation Site no 37

New York, New York, 10029, United States

Location

Polichem Investigation Site no 4

Rochester, New York, 14609, United States

Location

Polichem Investigation Site no 48

Rochester, New York, 14623, United States

Location

Polichem Investigation Site no 46

High Point, North Carolina, 27262, United States

Location

Polichem Investigation Site no 27

Winston-Salem, North Carolina, 27104, United States

Location

Polichem Investigation Site no 44

Cincinnati, Ohio, 45249, United States

Location

Polichem Investigation Site no 40

Norman, Oklahoma, 71071, United States

Location

Polichem Investigation Site no 14

Portland, Oregon, 97239, United States

Location

Polichem Investigation Site no 51

Johnston, Rhode Island, 02919, United States

Location

Polichem Investigation Site no 8

Charleston, South Carolina, 29401, United States

Location

Polichem Investigation Site no 26

Rapid City, South Dakota, 57702, United States

Location

Polichem Investigation Site no 12

Goodlettsville, Tennessee, 37072, United States

Location

Polichem Investigation Site no 7

Knoxville, Tennessee, 37922, United States

Location

Polichem Investigation Site no 56

Arlington, Texas, 76011, United States

Location

Polichem Investigation Site no 43

Dallas, Texas, 75246, United States

Location

Polichem Investigation Site no 42

Pflugerville, Texas, 78660, United States

Location

Polichem Investigation Site no 33

San Antonio, Texas, 78213, United States

Location

Polichem Investigation Site no 53

San Antonio, Texas, 78229, United States

Location

Polichem Investigation Site no 55

San Antonio, Texas, 78249, United States

Location

Polichem Investigation Site no 50

Murray, Utah, 84107, United States

Location

Polichem Investigation Site no 15

Norfolk, Virginia, 23502, United States

Location

Polichem Investigation Site no 30

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Maurizio Caserini, MD

  Polichem SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 15, 2017
• Study Start: May 15, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

US (58)