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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Phase 2b, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of SNA-120 (Pegcantratinib) Ointment in Subjects With Pruritus Associated With Psoriasis Vulgaris

Conditions
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Pruritus, Psoriasis Vulgaris

Intervention / Treatment
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* Drug: SNA-120
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SNA-120 (0.05% )<br>Pegcantratinib Ointment | Drug: SNA-120<br>* Pegcantratinib ointment<br>|
| Active Comparator: SNA-120 (0.5%)<br>Pegcantratinib Ointment | Drug: SNA-120<br>* Pegcantratinib ointment<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* Placebo ointment to mimic Pegcantratinib ointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where 0 represents no itch and 10 represents worst possible itching | week 1 | 
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where 0 represents no itch and 10 represents worst possible itching | week 2 | 
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where 0 represents no itch and 10 represents worst possible itching | week 4 | 
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where 0 represents no itch and 10 represents worst possible itching | week 6 | 
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where 0 represents no itch and 10 represents worst possible itching | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects (≥ 1 grade change) on IGA scale | Investigator Global Assessment | week 12 | 
| Proportion of subjects (≥ 2 grade change) on IGA scale | Investigator Global Assessment | week 12 | 
| Proportion of subjects categorized as a 0 or 1 on IGA scale and minimum improvement of 2 categories | Investigator Global Assessment | baseline and week 12 | 
| Change in PASI-50 | Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index | baseline and week 12 |