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

• Status: Completed
• Trial end date: 2018-12-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sienna Biopharmaceuticals
• Treatments: Calcipotriene; Calcitriol

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