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

June 11, 2018 updated by: Galderma R&D

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei, Taiwan
        • Galderma Investigational Site
      • Taichung, Taiwan
        • Galderma Investigational Site
      • Tainan, Taiwan
        • Galderma Investigational Site
      • Taipei, Taiwan
        • Galderma investigational site 1
      • Taipei, Taiwan
        • Galderma investigational site 2
      • Taipei, Taiwan
        • Galderma investigational site 3
      • Taipei, Taiwan
        • Galderma investigational site 4
      • Taipei, Taiwan
        • Galderma investigational site 5
      • Taipei, Taiwan
        • Galderma investigational site 6
    • Taoyuan
      • Lincuo, Taoyuan, Taiwan
        • Galderma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NP000888
Pharmaceutical form: Ointment
Drug: NP000888
270 µg/g topical (BID) for 24 weeks
PLACEBO_COMPARATOR: Vehicle
Pharmaceutical form: Ointment
Drug: Vehicle
Topical (BID) for 24 weeks
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate in IGA score (clear or almost clear)
Time Frame: Baseline - Week 12
Success rate in IGA score (clear or almost clear)
Baseline - Week 12
Percent change from baseline in total mtNAPSI scores
Time Frame: Baseline - Week 24
Mean percent change from baseline in total mtNAPSI scores
Baseline - Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2017

Primary Completion (ACTUAL)

May 3, 2018

Study Completion (ACTUAL)

May 28, 2018

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.100535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriasis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe