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

Sienna Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Psoriasis Vulgaris; Pruritus

Treatments: Drug: Vehicle; Drug: SNA-120

Study type: Interventional

Funder types: Industry

Identifiers

NCT03322137

SNA-120-201

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 3 patient groups, including a placebo group

SNA-120 (0.05% )

Active Comparator group

Description:

Pegcantratinib Ointment

Treatment:

Drug: SNA-120

SNA-120 (0.5%)

Active Comparator group

Description:

Pegcantratinib Ointment

Treatment:

Drug: SNA-120

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle