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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pruritus, Psoriasis Vulgaris

In brief

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.

Key facts

Study ID

NCT03322137

Run by

Sienna Biopharmaceuticals

People needed

208

Starts

2017-10-10

Expected to finish

2018-10-22

Last updated by the study team

2019-02-08

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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