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

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

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

Locations (38): Site 025
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Scottsdale, Arizona, United States
Sienna 022
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Fort Smith, Arkansas, United States
Site 028
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Fountain Valley, California, United States
Sienna 009
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Fremont, California, United States
Sienna 008
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San Diego, California, United States
Sienna 020
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Santa Monica, California, United States
Sienna 015
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Denver, Colorado, United States
Sienna 005
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Farmington, Connecticut, United States
Site 030
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Shelton, Connecticut, United States
Site 026
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Doral, Florida, United States
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Site 025
🇺🇸Scottsdale, Arizona, United States