safety, tolerability and efficacy of sna-120 for treatment of pruritus and psoriasis in subjects treated with calcipotriene

Conditions: Pruritus; Psoriasis

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.

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.

Eligibility criteria:
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