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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995473
• Other study ID #: RD.03.SPR.100535
• Status: Completed
• Phase: Phase 2
• Start date: February 8, 2017
• Est. completion date: May 28, 2018

Study information

• Verified date: June 2018
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 28, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• NP000888
270 µg/g topical (BID) for 24 weeks
• Vehicle
Topical (BID) for 24 weeks

Locations

Country	Name	City	State
Taiwan	Galderma Investigational Site	Lincuo	Taoyuan
Taiwan	Galderma investigational site	New Taipei
Taiwan	Galderma investigational site	Taichung
Taiwan	Galderma investigational site	Tainan
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	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate in IGA score (clear or almost clear)	Success rate in IGA score (clear or almost clear)	Baseline - Week 12
Primary	Percent change from baseline in total mtNAPSI scores	Mean percent change from baseline in total mtNAPSI scores	Baseline - Week 24