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

NCT02995473 | Completed Phase 2

• 1 other identifier: RD.03.SPR.100535
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 10

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

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Success rate in IGA score (clear or almost clear)

  Success rate in IGA score (clear or almost clear)

  Baseline - Week 12

• Percent change from baseline in total mtNAPSI scores

  Mean percent change from baseline in total mtNAPSI scores

  Baseline - Week 24

Study Arms (2)

NP000888

EXPERIMENTAL

Pharmaceutical form: Ointment

Drug: NP000888

Vehicle

PLACEBO COMPARATOR

Pharmaceutical form: Ointment

Drug: Vehicle

Interventions

NP000888 DRUG

270 µg/g topical (BID) for 24 weeks

NP000888

Vehicle DRUG

Topical (BID) for 24 weeks

Also known as: Placebo

Vehicle

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (10)

Galderma Investigational Site

Lincuo, Taoyuan, Taiwan

Location

Galderma investigational site

New Taipei City, Taiwan

Location

Galderma investigational site

Taichung, Taiwan

Location

Galderma investigational site

Tainan, Taiwan

Location

Galderma investigational site 1

Taipei, Taiwan

Location

Galderma investigational site 2

Taipei, Taiwan

Location

Galderma investigational site 3

Taipei, Taiwan

Location

Galderma investigational site 4

Taipei, Taiwan

Location

Galderma investigational site 5

Taipei, Taiwan

Location

Galderma investigational site 6

Taipei, Taiwan

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: February 8, 2017
• Primary Completion: May 3, 2018
• Study Completion: May 28, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (10)