Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene
Status: | Completed |
---|---|
Conditions: | Allergy, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Otolaryngology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/10/2019 |
Start Date: | February 12, 2018 |
End Date: | December 10, 2018 |
An Exploratory, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of SNA-120 (Pegcantratinib) Ointment for the Symptomatic Treatment of Persistent Pruritus and Psoriasis in Subjects Being Treated With Calcipotriene Ointment
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.
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.
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.
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
We found this trial at
18
sites
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