Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene

Study Overview
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Brief Summary
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A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when administered topically with calcipotriene ointment for the treatment of pruritus and psoriasis.

Detailed Description
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All subjects are required to meet eligibility requirements and undergo a calcipotriene run-in period (Part A) prior to qualifying and randomizing into the study to receive either SNA-120 or Placebo ointment in combination with calcipotriene ointment (Part B). Combination therapy (SNA-120 ointment + calcipotriene ointment or Placebo ointment + calcipotriene ointment) is to continue over an 8 week period to evaluate safety, tolerability and the efficacy of treatment on both persistent pruritus and the visible signs and symptoms of psoriasis.

Official Title
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An Exploratory, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of SNA-120 (Pegcantratinib) Ointment for the Symptomatic Treatment of Persistent Pruritus and Psoriasis in Subjects Being Treated With Calcipotriene Ointment

Conditions
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Pruritus, Psoriasis

Intervention / Treatment
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* Drug: SNA-120
* Drug: Placebo
* Drug: Calcipotriene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Stable psoriasis for at least 6 months prior to screening Chronic pruritus of the psoriasis plaques at least 6 weeks prior to screening At least moderate baseline overall itch associated with psoriatic plaques Willing and able to undergo a 4-week run-in with calcipotriene ointment dosing and remain on this stable regimen throughout the study Mild or moderate psoriasis at screening and baseline Subject's plaques are amenable to treatment with a topical medication Willing and able to discontinue all other topical products to treat psoriasis and/or itch, including topical steroids Willing and able to avoid prolonged exposure of the designated treatment plaques to ultraviolet (UV) radiation (natural and artificial) for the duration of the study Women of childbearing potential must have a negative pregnancy test and must agree to use highly effective methods of contraception during the study Men who engage in sexual activity that can result in fathering 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 Current or past history of hypercalcemia, Vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders Thyroid abnormalities that, in the opinion of the investigator, are clinically relevant and may affect assessments Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis Subjects with a clinical diagnosis of bacterial infection of the skin Subjects who have previously failed treatment with or failed to tolerate treatment with calcipotriene Known hypersensitivity to SNA-120 (pegcantratinib), calcipotriene, the study treatment excipients, and /or polyethylene glycol (PEG), or a history of drug or other allergy that, in the opinion of the investigator, 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 or 5 half-lives of investigational drug (whichever is longer) of baseline Women who are pregnant or lactating, or are planning to become pregnant during the study Subjects previously participating in any SNA-120 (and/or CT327 or pegcantratinib) clinical studies

Ages Eligible for Study
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Minimum Age: 18 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 + Calcipotriene<br> | Drug: SNA-120<br>* SNA-120 (0.5%) active ointment<br>Drug: Calcipotriene<br>* Calcipotriene ointment (0.005%)<br>|
| Placebo Comparator: Placebo + Calcipotriene<br> | Drug: Placebo<br>* Vehicle Ointment<br>Drug: Calcipotriene<br>* Calcipotriene ointment (0.005%)<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) from baseline | 11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching) | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Investigator Global Assessment (IGA) from baseline | 5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe) | week 8 | 
| Change in Psoriasis Area Severity Index (PASI) from baseline | A quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance (0 = no disease to 72 = maximum disease) | week 8 |