Study of the Efficacy and Safety of Topical P-3073 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: Not yet recruiting

Administrative data

• NCT number: NCT03209388
• Other study ID #: PM1440
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 7, 2017
• Last updated: July 4, 2017
• Start date: September 24, 2017
• Est. completion date: October 28, 2018

Study information

• Verified date: July 2017
• Source: Almirall, 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.

To evaluate the safety and the efficacy of P-3073 nail solution in the treatment of nail psoriasis, a phase II study to compare P-3073 versus placebo and versus another active compound, P-3072 containing cyclosporine 5%, was performed.

The primary objective of the present phase III study will be the assess the efficacy of topical P-3073 in the treatment of mild to moderate psoriatic fingernail/s. The evaluation of the primary endpoint will be made using the Nail Psoriasis Severity Index (NAPSI). The mild to moderate status will be defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline).

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 (NAPSI =1 or ≥2) according to a computer-generated randomization list.

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, preferably at bedtime, on clean and dry nail(s).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 470
• Est. completion date: October 28, 2018
• Est. primary completion date: October 28, 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

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