Status:
COMPLETED
Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene
Lead Sponsor:
Sienna Biopharmaceuticals
Conditions:
Pruritus
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 oi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2018
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03448081
Start Date
February 12 2018
End Date
December 10 2018
Last Update
February 8 2019
Active Locations (20)
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1
Sienna 018
Anniston, Alabama, United States, 36207
2
Sienna 009
Mobile, Alabama, United States, 36608
3
Sienna 019
Fountain Valley, California, United States, 92708
4
Sienna 007
Los Angeles, California, United States, 90045