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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pruritus, Psoriasis

In brief

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.

Key facts

Study ID

NCT03448081

Run by

Sienna Biopharmaceuticals

People needed

73

Starts

2018-02-12

Expected to finish

2018-12-10

Last updated by the study team

2019-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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