Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
- Registration Number
- NCT03322137
- Lead Sponsor
- Sienna Biopharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle - SNA-120 (0.5%) SNA-120 Pegcantratinib Ointment SNA-120 (0.05% ) SNA-120 Pegcantratinib Ointment
- Primary Outcome Measures
Name Time Method Change in Itch Numeric Rating Scale scores (I-NRS) week 8 The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
- Secondary Outcome Measures
Name Time Method Proportion of subjects (≥ 1 grade change) on IGA scale week 12 Investigator Global Assessment
Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories baseline and week 12 Investigator Global Assessment
Change in PASI-50 baseline and week 12 Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index
Proportion of subjects (≥ 2 grade change) on IGA scale week 12 Investigator Global Assessment
Trial Locations
- Locations (38)
Sienna 009
🇺🇸Fremont, California, United States
Sienna 019
🇺🇸Largo, Florida, United States
Site 025
🇺🇸Scottsdale, Arizona, United States
Sienna 017
🇺🇸North Miami Beach, Florida, United States
Site 034
🇺🇸Pflugerville, Texas, United States
Sienna 014
🇺🇸Norfolk, Virginia, United States
Site 028
🇺🇸Fountain Valley, California, United States
Sienna 020
🇺🇸Santa Monica, California, United States
Site 031
🇺🇸Pittsburgh, Pennsylvania, United States
Site 027
🇺🇸West Palm Beach, Florida, United States
Site 041
🇺🇸Norman, Oklahoma, United States
Sienna 021
🇺🇸Dallas, Texas, United States
Sienna 008
🇺🇸San Diego, California, United States
Sienna 002
🇺🇸Fridley, Minnesota, United States
Sienna 015
🇺🇸Denver, Colorado, United States
Sienna 022
🇺🇸Fort Smith, Arkansas, United States
Site 030
🇺🇸Shelton, Connecticut, United States
Sienna 007
🇺🇸Murray, Utah, United States
Site 038
🇺🇸Metairie, Louisiana, United States
Site 039
🇺🇸Clarkston, Michigan, United States
Sienna 005
🇺🇸Farmington, Connecticut, United States
Sienna 004
🇺🇸East Windsor, New Jersey, United States
Site 026
🇺🇸Doral, Florida, United States
Sienna 024
🇺🇸Ocala, Florida, United States
Sienna 010
🇺🇸New Albany, Indiana, United States
Sienna 011
🇺🇸Plainfield, Indiana, United States
Site 029
🇺🇸Macon, Georgia, United States
Sienna 023
🇺🇸Louisville, Kentucky, United States
Site 032
🇺🇸Rockville, Maryland, United States
Sienna 001
🇺🇸Saint Louis, Missouri, United States
Sienna 013
🇺🇸Albuquerque, New Mexico, United States
Sienna 016
🇺🇸High Point, North Carolina, United States
Site 037
🇺🇸Rochester, New York, United States
Site 035
🇺🇸Murfreesboro, Tennessee, United States
Sienna 018
🇺🇸Houston, Texas, United States
Sienna 006
🇺🇸Winston-Salem, North Carolina, United States
Sienna 003
🇺🇸Portland, Oregon, United States
Sienna 012
🇺🇸Austin, Texas, United States