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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Pruritus
• Intervention / Treatment: Drug: SNA-120; Drug: Calcipotriene; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Sienna 006
  • Ontario
    • Peterborough, Ontario, Canada, K9J 5K2
      • Sienna 008
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Sienna 003
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Sienna 018
    • Mobile, Alabama, United States, 36608
      • Sienna 009
  • California
    • Fountain Valley, California, United States, 92708
      • Sienna 019
    • Los Angeles, California, United States, 90045
      • Sienna 007
    • Sherman Oaks, California, United States, 91403
      • Site 016
  • Florida
    • Coral Gables, Florida, United States, 33143
      • Site 013
    • Sanford, Florida, United States, 32771
      • Site 015
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Site 012
  • Michigan
    • Warren, Michigan, United States, 48088
      • Sienna 011
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Sienna 005
  • New York
    • Rochester, New York, United States, 14623
      • Sienna 020
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Site 014
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Sienna 002
  • Texas
    • Austin, Texas, United States, 78745
      • Sienna 017
    • Houston, Texas, United States, 77004
      • Sienna 010
    • Pflugerville, Texas, United States, 78660
      • Sienna 021
    • San Antonio, Texas, United States, 78213
      • Sienna 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SNA-120 + Calcipotriene	Drug: SNA-120; SNA-120 (0.5%) active ointment; Drug: Calcipotriene; Calcipotriene ointment (0.005%)
Placebo Comparator: Placebo + Calcipotriene	Drug: Calcipotriene; Calcipotriene ointment (0.005%); Drug: Placebo; Vehicle Ointment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Investigator Global Assessment (IGA) from baseline	5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe)	week 8
Change in Psoriasis Area Severity Index (PASI) from baseline	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)	week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety measured by frequency of Adverse Events	Frequency of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10	week 10
Safety measured by severity of Adverse Events	Severity of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10	week 10
Safety measured by change in clinical lab results from baseline	biochemistry lab assessments	week 10
Safety measured by change in clinical lab results from baseline	Clinical laboratory assessments include urinalysis (pH, glucose, protein)	week 10
Safety measured by change in clinical lab results from baseline	hematology lab assessments	week 10
Safety measured by change from baseline in blood pressure	Systolic/diastolic blood pressure (BP in mmHg) - measured every full clinic visit, from baseline through week 10	week 10
Safety measured by change from baseline in pulse	Measured in beats per minute (bpm) - measured every full clinic visit, from baseline through week 10	week 10
Safety measured by number of abnormal physical examinations from baseline		week 8
Safety measured by PR/PQ intervals measured by 12-lead ECG	Safety measured by PR/PQ intervals measured by 12-lead ECG at screening	week -4
Safety measured by PR/PQ intervals measured by 12-lead ECG	Safety measured by PR/PQ intervals measured by 12-lead ECG at baseline	week 0
Safety measured by PR/PQ intervals measured by 12-lead ECG	Safety measured by PR/PQ intervals measured by 12-lead ECG at week 4	week 4
Safety measured by PR/PQ intervals measured by 12-lead ECG	Safety measured by PR/PQ intervals measured by 12-lead ECG at week 8	week 8
Safety measured by QRS duration measured by 12-lead ECG	Safety measured by QRS duration measured by 12-lead ECG at screening	week -4
Safety measured by QRS duration measured by 12-lead ECG	Safety measured by QRS duration measured by 12-lead ECG at baseline	week 0
Safety measured by QRS duration measured by 12-lead ECG	Safety measured by QRS duration measured by 12-lead ECG at week 4	week 4
Safety measured by QRS duration measured by 12-lead ECG	Safety measured by QRS duration measured by 12-lead ECG at week 8	week 8
Safety measured by QT intervals measured by 12-lead ECG	Safety measured by QT intervals measured by 12-lead ECG at screening	week -4
Safety measured by QT intervals measured by 12-lead ECG	Safety measured by QT intervals measured by 12-lead ECG at baseline	week 0
Safety measured by QT intervals measured by 12-lead ECG	Safety measured by QT intervals measured by 12-lead ECG at week 4	week 4
Safety measured by QT intervals measured by 12-lead ECG	Safety measured by QT intervals measured by 12-lead ECG at week 8	week 8

Collaborators and Investigators

• Sponsor: Sienna Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): November 21, 2018
• Study Completion (Actual): December 10, 2018

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Manifestations; Psoriasis; Pruritus; Dermatologic Agents; Calcipotriene
• Other Study ID Numbers: SNA-120-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No