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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 21, 2018

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 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.

Interventions

  • Drug: SNA-120
    • SNA-120 (0.5%) active ointment
  • Drug: Placebo
    • Vehicle Ointment
  • Drug: Calcipotriene
    • Calcipotriene ointment (0.005%)

Arms, Groups and Cohorts

  • Active Comparator: SNA-120 + Calcipotriene
  • Placebo Comparator: Placebo + Calcipotriene

Clinical Trial Outcome Measures

Primary Measures

  • Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
    • Time Frame: week 8
    • 11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching)

Secondary Measures

  • Change in Investigator Global Assessment (IGA) from baseline
    • Time Frame: week 8
    • 5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe)
  • Change in Psoriasis Area Severity Index (PASI) from baseline
    • Time Frame: week 8
    • A quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance (0 = no disease to 72 = maximum disease)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sienna Biopharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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