Status:
COMPLETED
Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
Lead Sponsor:
Sienna Biopharmaceuticals
Conditions:
Pruritus
Psoriasis Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 itse...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2018
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT03322137
Start Date
October 10 2017
End Date
October 22 2018
Last Update
February 8 2019
Active Locations (38)
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1
Site 025
Scottsdale, Arizona, United States, 85255
2
Sienna 022
Fort Smith, Arkansas, United States, 72916
3
Site 028
Fountain Valley, California, United States, 92708
4
Sienna 009
Fremont, California, United States, 94538