Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene
NCT ID: NCT03448081
Last Updated: 2019-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2018-02-12
2018-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SNA-120 + Calcipotriene
SNA-120
SNA-120 (0.5%) active ointment
Calcipotriene
Calcipotriene ointment (0.005%)
Placebo + Calcipotriene
Placebo
Vehicle Ointment
Calcipotriene
Calcipotriene ointment (0.005%)
Interventions
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SNA-120
SNA-120 (0.5%) active ointment
Placebo
Vehicle Ointment
Calcipotriene
Calcipotriene ointment (0.005%)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sienna Biopharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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SNA-120-202
Identifier Type: -
Identifier Source: org_study_id
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