Pruritus, Psoriasis Vulgaris
Conditions
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.
Interventions
DRUGSNA-120
Pegcantratinib ointment
DRUGVehicle
Placebo ointment to mimic Pegcantratinib ointment
Sponsors
Sienna Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Itch Numeric Rating Scale scores (I-NRS) | week 1 | The I-NRS is a 11 point scale, where 0 represents no itch and 10 represents worst possible itching |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects (≥ 1 grade change) on IGA scale | week 12 | Investigator Global Assessment |
| Proportion of subjects (≥ 2 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety measured by change in pulse from baseline | up to 12 weeks | Pulse (beats per minute \[bpm\]) |
| Safety measured by QRS duration measured by 12-lead ECG | week 2 | — |
| Safety measured by PR/PQ intervals measured by 12-lead ECG | week 2 | — |
| Safety measured by number of abnormal physical examination changes | baseline and week 12 | Any abnormal physical examination changes from baseline and week 12 |
| Safety measured by QT interval measure by 12-lead ECG | week 2 | — |
| Safety measured by incidence and severity of adverse events | up to 12 weeks | — |
| Safety measured by change in clinical laboratory results from baseline | up to 12 weeks | urinalysis lab assessments |
| Safety measured by change in blood pressure from baseline | up to 12 weeks | systolic/diastolic blood pressure (BP in mmHg) |
Countries
United States
Outcome results
None listed