Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
NCT ID: NCT03322137
Last Updated: 2019-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2017-10-10
2018-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SNA-120 (0.05% )
Pegcantratinib Ointment
SNA-120
Pegcantratinib ointment
SNA-120 (0.5%)
Pegcantratinib Ointment
SNA-120
Pegcantratinib ointment
Vehicle
Vehicle
Placebo ointment to mimic Pegcantratinib ointment
Interventions
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SNA-120
Pegcantratinib ointment
Vehicle
Placebo ointment to mimic Pegcantratinib ointment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Sienna Biopharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Site 025
Scottsdale, Arizona, United States
Sienna 022
Fort Smith, Arkansas, United States
Site 028
Fountain Valley, California, United States
Sienna 009
Fremont, California, United States
Sienna 008
San Diego, California, United States
Sienna 020
Santa Monica, California, United States
Sienna 015
Denver, Colorado, United States
Sienna 005
Farmington, Connecticut, United States
Site 030
Shelton, Connecticut, United States
Site 026
Doral, Florida, United States
Sienna 019
Largo, Florida, United States
Sienna 017
North Miami Beach, Florida, United States
Sienna 024
Ocala, Florida, United States
Site 027
West Palm Beach, Florida, United States
Site 029
Macon, Georgia, United States
Sienna 010
New Albany, Indiana, United States
Sienna 011
Plainfield, Indiana, United States
Sienna 023
Louisville, Kentucky, United States
Site 038
Metairie, Louisiana, United States
Site 032
Rockville, Maryland, United States
Site 039
Clarkston, Michigan, United States
Sienna 002
Fridley, Minnesota, United States
Sienna 001
St Louis, Missouri, United States
Sienna 004
East Windsor, New Jersey, United States
Sienna 013
Albuquerque, New Mexico, United States
Site 037
Rochester, New York, United States
Sienna 016
High Point, North Carolina, United States
Sienna 006
Winston-Salem, North Carolina, United States
Site 041
Norman, Oklahoma, United States
Sienna 003
Portland, Oregon, United States
Site 031
Pittsburgh, Pennsylvania, United States
Site 035
Murfreesboro, Tennessee, United States
Sienna 012
Austin, Texas, United States
Sienna 021
Dallas, Texas, United States
Sienna 018
Houston, Texas, United States
Site 034
Pflugerville, Texas, United States
Sienna 007
Murray, Utah, United States
Sienna 014
Norfolk, Virginia, United States
Countries
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Other Identifiers
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SNA-120-201
Identifier Type: -
Identifier Source: org_study_id
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