Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-08

Study Completion Date

2018-05-28

Brief Summary

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This study is to evaluate the efficacy and safety of topical application of NP000888 ointment compared to vehicle in plaque and fingernail psoriasis subjects.

Duration of administration: 24 weeks

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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NP000888

Pharmaceutical form: Ointment

Group Type EXPERIMENTAL

NP000888

Intervention Type DRUG

270 µg/g topical (BID) for 24 weeks

Vehicle

Pharmaceutical form: Ointment

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical (BID) for 24 weeks

Interventions

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NP000888

270 µg/g topical (BID) for 24 weeks

Intervention Type DRUG

Vehicle

Topical (BID) for 24 weeks

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* Subject with a clinical diagnosis of plaque psoriasis defined as an IGA score at least 2 (mild) at Screening and Baseline visits
* Subject with a plaque psoriasis total Body Surface Area (BSA) involvement of at least equal to 3% but less than 20% at Screening and Baseline visits
* Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a fingernail PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits

Exclusion Criteria

* Subject with guttata, erythrodermic, exfoliative, inverse, pustular or palmo plantar, infected or ulcerated psoriasis or psoriasis involvement \>=20% BSA or an unstable form of psoriasis, defined as at least one flare in the previous month before Screening visit
* Subject with chronic plaque psoriasis who are candidates for systemic therapy at Screening and Baseline visits
* Subject with clinical signs of psoriatic arthritis at Screening and Baseline visits
* Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a nail-PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No