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Completed

NCT Number: NCT02995473

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

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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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Galderma Investigational Site, Lincuo, Taoyuan, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NP000888

Drug

270 µg/g topical (BID) for 24 weeks

Vehicle

Drug

Topical (BID) for 24 weeks

Other names: Placebo

Primary outcomes

  1. Success rate in IGA score (clear or almost clear)

    Time frame: Baseline - Week 12

    Success rate in IGA score (clear or almost clear)

  2. Percent change from baseline in total mtNAPSI scores

    Time frame: Baseline - Week 24

    Mean percent change from baseline in total mtNAPSI scores

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Multi-center, Randomized, Vehicle-controlled, Investigator-blinded, Parallel Groups Study to Evaluate the Efficacy and Safety of NP000888 in Subjects With Plaque and Nail Psoriasis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 16, 2016
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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