Psoriasis Clinical Trial

Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris

Summary

To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (PV) and PV itself.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Stable PV for at least 6 months prior to screening
Chronic pruritus of the PV plaques to be present for at least 6 weeks prior to screening
Mild to moderate PV at screening and baseline
Has a target plaque at baseline on the trunk and/or limbs
Subject's plaques are amenable to treatment with a topical ointment medication
Willing and able to comply with the study instructions and attend all scheduled study visits.
Willing to avoid prolonged exposure of the designated treatment plaques to ultraviolet radiation
Females of childbearing potential must have a negative pregnancy test at baseline before randomization and must agree to use highly effective contraception during the study
Men who are sexually active and can father children must agree to use highly effective forms of contraception during the study

Exclusion Criteria:

Underlying conditions other than psoriasis that, in the opinion of the investigator, currently cause or influence pruritus of the overall skin
Positive hepatitis serology
Thyroid abnormalities that may impact itching
Subjects with spontaneously improving or rapidly deteriorating PV and/or pruritus
Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
Active psoriasis or itch affecting the palmar/plantar regions
Subjects with a clinical diagnosis of bacterial infection of the skin
Any major medical illness or symptoms of a clinically significant illness that may influence the study outcome
Any acute chronic medical or psychiatric condition or laboratory abnormality that would make them unsuitable for participation in this study
Known hypersensitivity to the study treatment excipients and /or polyethylene glycol, that contraindicates participation
Currently enrolled in an investigational drug or device study or has used an investigational drug or an investigational device treatment within 30 days of randomization/baseline (Note: Subjects who are enrolled in a long-term follow-up study and are not actively receiving an investigational drug or investigational device treatment may be eligible for participation in this study)
Female who is pregnant or lactating, or is planning to become pregnant during the study
Subjects participating in any previous SNA-120 (and/or CT327) clinical studies

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

208

Study ID:

NCT03322137

Recruitment Status:

Completed

Sponsor:

Sienna Biopharmaceuticals

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There are 38 Locations for this study

See Locations Near You

Site 025
Scottsdale Arizona, 85255, United States
Sienna 022
Fort Smith Arkansas, 72916, United States
Site 028
Fountain Valley California, 92708, United States
Sienna 009
Fremont California, 94538, United States
Sienna 008
San Diego California, 92123, United States
Sienna 020
Santa Monica California, 90404, United States
Sienna 015
Denver Colorado, 80220, United States
Sienna 005
Farmington Connecticut, 06032, United States
Site 030
Shelton Connecticut, 06484, United States
Site 026
Doral Florida, 33122, United States
Sienna 019
Largo Florida, 33770, United States
Sienna 017
North Miami Beach Florida, 33162, United States
Sienna 024
Ocala Florida, 34471, United States
Site 027
West Palm Beach Florida, 33406, United States
Site 029
Macon Georgia, 31217, United States
Sienna 010
New Albany Indiana, 47150, United States
Sienna 011
Plainfield Indiana, 46168, United States
Sienna 023
Louisville Kentucky, 40202, United States
Site 038
Metairie Louisiana, 70006, United States
Site 032
Rockville Maryland, 20850, United States
Site 039
Clarkston Michigan, 48346, United States
Sienna 002
Fridley Minnesota, 55432, United States
Sienna 001
Saint Louis Missouri, 63117, United States
Sienna 004
East Windsor New Jersey, 08520, United States
Sienna 013
Albuquerque New Mexico, 87106, United States
Site 037
Rochester New York, 14623, United States
Sienna 016
High Point North Carolina, 27626, United States
Sienna 006
Winston-Salem North Carolina, 27104, United States
Site 041
Norman Oklahoma, 73071, United States
Sienna 003
Portland Oregon, 97223, United States
Site 031
Pittsburgh Pennsylvania, 15213, United States
Site 035
Murfreesboro Tennessee, 37130, United States
Sienna 012
Austin Texas, 78759, United States
Sienna 021
Dallas Texas, 75246, United States
Sienna 018
Houston Texas, 77030, United States
Site 034
Pflugerville Texas, 78660, United States
Sienna 007
Murray Utah, 84107, United States
Sienna 014
Norfolk Virginia, 23502, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

208

Study ID:

NCT03322137

Recruitment Status:

Completed

Sponsor:


Sienna Biopharmaceuticals

How clear is this clinincal trial information?

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