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

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change in Itch Numeric Rating Scale scores (I-NRS) from baseline	week 8	11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching)

Secondary Outcome Measures

Name	Time	Method
Change in Investigator Global Assessment (IGA) from baseline	week 8	5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe)
Change in Psoriasis Area Severity Index (PASI) from baseline	week 8	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)

Locations (20): Site 015
🇺🇸
Sanford, Florida, United States
Site 013
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Coral Gables, Florida, United States
Sienna 003
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Montreal, Quebec, Canada
Sienna 011
🇺🇸
Warren, Michigan, United States
Sienna 009
🇺🇸
Mobile, Alabama, United States
Sienna 019
🇺🇸
Fountain Valley, California, United States
Sienna 005
🇺🇸
Berlin, New Jersey, United States
Sienna 007
🇺🇸
Los Angeles, California, United States
Site 012
🇺🇸
Indianapolis, Indiana, United States
Sienna 010
🇺🇸
Houston, Texas, United States
Sienna 002
🇺🇸
Oklahoma City, Oklahoma, United States
Sienna 001
🇺🇸
San Antonio, Texas, United States
Sienna 017
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Austin, Texas, United States
Sienna 018
🇺🇸
Anniston, Alabama, United States
Site 016
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Sherman Oaks, California, United States
Sienna 020
🇺🇸
Rochester, New York, United States
Sienna 021
🇺🇸
Pflugerville, Texas, United States
Sienna 006
🇨🇦
Surrey, British Columbia, Canada
Sienna 008
🇨🇦
Peterborough, Ontario, Canada
Site 014
🇺🇸
Raleigh, North Carolina, United States