Back to resultsEfficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
NP000888
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis
Eligibility Criteria
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.
Sites / Locations
- Galderma Investigational Site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site 1
- Galderma investigational site 2
- Galderma investigational site 3
- Galderma investigational site 4
- Galderma investigational site 5
- Galderma investigational site 6
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NP000888
Vehicle
Arm Description
Pharmaceutical form: Ointment
Pharmaceutical form: Ointment
Outcomes
Primary Outcome Measures
Success rate in IGA score (clear or almost clear)
Success rate in IGA score (clear or almost clear)
Percent change from baseline in total mtNAPSI scores
Mean percent change from baseline in total mtNAPSI scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02995473
Brief Title
Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NP000888
Arm Type
Experimental
Arm Description
Pharmaceutical form: Ointment
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Pharmaceutical form: Ointment
Intervention Type
Drug
Intervention Name(s)
NP000888
Intervention Description
270 µg/g topical (BID) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo
Intervention Description
Topical (BID) for 24 weeks
Primary Outcome Measure Information:
Title
Success rate in IGA score (clear or almost clear)
Description
Success rate in IGA score (clear or almost clear)
Time Frame
Baseline - Week 12
Title
Percent change from baseline in total mtNAPSI scores
Description
Mean percent change from baseline in total mtNAPSI scores
Time Frame
Baseline - Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Galderma Investigational Site
City
Lincuo
State/Province
Taoyuan
Country
Taiwan
Facility Name
Galderma investigational site
City
New Taipei
Country
Taiwan
Facility Name
Galderma investigational site
City
Taichung
Country
Taiwan
Facility Name
Galderma investigational site
City
Tainan
Country
Taiwan
Facility Name
Galderma investigational site 1
City
Taipei
Country
Taiwan
Facility Name
Galderma investigational site 2
City
Taipei
Country
Taiwan
Facility Name
Galderma investigational site 3
City
Taipei
Country
Taiwan
Facility Name
Galderma investigational site 4
City
Taipei
Country
Taiwan
Facility Name
Galderma investigational site 5
City
Taipei
Country
Taiwan
Facility Name
Galderma investigational site 6
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis
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