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

Nail Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03079973
• Other study ID #: PM1440
• Status: Withdrawn
• Phase: Phase 3
• First received: March 9, 2017
• Last updated: January 9, 2018
• Start date: May 15, 2017
• Est. completion date: July 2018

Study information

• Verified date: January 2018
• Source: Polichem S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT03209388

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nail Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
United States	Polichem Investigation Site no 31	Ann Arbor	Michigan
United States	Polichem Investigation Site no 56	Arlington	Texas
United States	Polichem Investigation Site no 2	Bay City	Michigan
United States	Polichem Investigation Site no 47	Birmingham	Alabama
United States	Polichem Investigation Site no 54	Buffalo	New York
United States	Polichem Investigation Site no 8	Charleston	South Carolina
United States	Polichem Investigation Site no 44	Cincinnati	Ohio
United States	Polichem Investigation Site no 36	Clearwater	Florida
United States	Polichem Investigation Site no 25	Columbus	Georgia
United States	Polichem Investigation Site no 43	Dallas	Texas
United States	Polichem Investigation Site no 58	East Windsor	New Jersey
United States	Polichem Investigation Site no 9	Fridley	Minnesota
United States	Polichem Investigation Site no 12	Goodlettsville	Tennessee
United States	Polichem Investigation Site no 46	High Point	North Carolina
United States	Polichem Investigation Site no 51	Johnston	Rhode Island
United States	Polichem Investigation Site no 7	Knoxville	Tennessee
United States	Polichem Investigation Site no 5	Las Vegas	Nevada
United States	Polichem Investigation Site no 11	Little Rock	Arkansas
United States	Polichem Investigation Site no 19	Louisville	Kentucky
United States	Polichem Investigation Site no 52	Louisville	Kentucky
United States	Polichem Investigation Site no 10	Miami	Florida
United States	Polichem Investigation Site no 13	Miami	Florida
United States	Polichem Investigation Site no 38	Miami	Florida
United States	Polichem Investigation Site no 20	Miami Lakes	Florida
United States	Polichem Investigation Site no 30	Milwaukee	Wisconsin
United States	Polichem Investigation Site no 50	Murray	Utah
United States	Polichem Investigation Site no 16	New Albany	Indiana
United States	Polichem Investigation Site no 32	New Orleans	Louisiana
United States	Polichem Investigation Site no 49	New Orleans	Louisiana
United States	Polichem Investigation Site no 37	New York	New York
United States	Polichem Investigation Site no 15	Norfolk	Virginia
United States	Polichem Investigation Site no 40	Norman	Oklahoma
United States	Polichem Investigation Site no 45	North Hollywood	California
United States	Polichem Investigation Site no 17	Ocala	Florida
United States	Polichem Investigation Site no 6	Omaha	Nebraska
United States	Polichem Investigation Site no 35	Ormond Beach	Florida
United States	Polichem Investigation Site no 22	Overland Park	Kansas
United States	Polichem Investigation Site no 42	Pflugerville	Texas
United States	Polichem Investigation Site no 21	Phoenix	Arizona
United States	Polichem Investigation Site no 14	Portland	Oregon
United States	Polichem Investigation Site no 41	Portsmouth	New Hampshire
United States	Polichem Investigation Site no 26	Rapid City	South Dakota
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 34	Rockville	Maryland
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 39	San Diego	California
United States	Polichem Investigation Site no 56	Santa Monica	California
United States	Polichem Investigation Site no 23	Skokie	Illinois
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 18	Washington	District of Columbia
United States	Polichem Investigation site no 3	West Des Moines	Iowa
United States	Polichem Investigation Site no 29	West Dundee	Illinois
United States	Polichem Investigation Site no 27	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Polichem S.A.	Almirall, S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients with target nail reaching NAPSI-75%	Defined as a reduction of =75% from baseline NAPSI score	Baseline - Week 24
Other	Proportion of affected nails at baseline reaching NAPSI-75%	Defined as a reduction of =75% from baseline NAPSI score	Baseline - Week 24
Other	Change from Baseline in Total NAPSI at Week 24	Defined as change in Nail Psoriasis Severity Index	Baseline - Week 24
Other	Time to reach NAPSI=0 in the target nail	Defined as time until NAPSI=0	Up to Week 24
Other	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
Other	Change from Baseline in Nail Psoriasis Visual Analogue Scale (VAS) Discomfort at Week 24	Defined as change in VAS	Baseline - Week 24
Other	Patient Acceptance of Study Therapy at Week 24	Note: Missing values will be replaced with the worst score	Baseline - Week 24
Other	Change from Baseline in EuroQoL-5Dimensions-5Levels (EQ-5D-5L) at Week 24	Defined as change in EQ-5D-5L	Baseline - Week 24
Other	Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 24	Defined as change in DLQI	Baseline - Week 24
Other	Change from Baseline in Short Form 36 Health Survey (SF-36) at Week 24	Defined as change in SF-36	Baseline - Week 24
Other	Change from Baseline in Nail Psoriasis Quality of Life Index (NPQ10) at Week 24	Defined as change in NPQ10	Baseline - Week 24
Primary	Proportion of patients with clear target nail at Week 24	Defined as Nail Psoriasis Severity Index (NAPSI) =0	Week 24
Secondary	Proportion of affected nails at baseline with NAPSI=0 at Week 24	Defined as affected nails with NAPSI=0	Baseline - Week 24
Secondary	Proportion of patients with clear target nail bed at Week 24	Defined as nail bed in NAPSI=0	Baseline - Week 24
Secondary	Proportion of patients with clear target nail matrix at Week 24	Defined as nail matrix in NAPSI=0	Baseline - Week 24