NCT02995473CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 61
- Locations
- 8
- Primary Endpoint
- Percent change from baseline in total mtNAPSI scores
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
NP000888
Experimental
Pharmaceutical form: Ointment
Intervention: NP000888 (Drug)
Vehicle
Placebo Comparator
Pharmaceutical form: Ointment
Intervention: Vehicle (Drug)
Outcomes
Primary Outcomes
Percent change from baseline in total mtNAPSI scores
Time Frame: Baseline - Week 24
Mean percent change from baseline in total mtNAPSI scores
Success rate in IGA score (clear or almost clear)
Time Frame: Baseline - Week 12
Success rate in IGA score (clear or almost clear)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (8)
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