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

• Status: Completed
• Trial end date: 2018-10-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sienna Biopharmaceuticals

Criteria

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