Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of SNA-120 (Pegcantratinib) Ointment in Subjects With Pruritus Associated With Psoriasis Vulgaris

To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (PV) and PV itself.

Study Overview

• Status: Completed
• Conditions: Pruritus; Psoriasis Vulgaris
• Intervention / Treatment: Drug: SNA-120; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Site 025
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Sienna 022
  • California
    • Fountain Valley, California, United States, 92708
      • Site 028
    • Fremont, California, United States, 94538
      • Sienna 009
    • San Diego, California, United States, 92123
      • Sienna 008
    • Santa Monica, California, United States, 90404
      • Sienna 020
  • Colorado
    • Denver, Colorado, United States, 80220
      • Sienna 015
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • Sienna 005
    • Shelton, Connecticut, United States, 06484
      • Site 030
  • Florida
    • Doral, Florida, United States, 33122
      • Site 026
    • Largo, Florida, United States, 33770
      • Sienna 019
    • North Miami Beach, Florida, United States, 33162
      • Sienna 017
    • Ocala, Florida, United States, 34471
      • Sienna 024
    • West Palm Beach, Florida, United States, 33406
      • Site 027
  • Georgia
    • Macon, Georgia, United States, 31217
      • Site 029
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Sienna 010
    • Plainfield, Indiana, United States, 46168
      • Sienna 011
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Sienna 023
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Site 038
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Site 032
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Site 039
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Sienna 002
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Sienna 001
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Sienna 004
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Sienna 013
  • New York
    • Rochester, New York, United States, 14623
      • Site 037
  • North Carolina
    • High Point, North Carolina, United States, 27626
      • Sienna 016
    • Winston-Salem, North Carolina, United States, 27104
      • Sienna 006
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Site 041
  • Oregon
    • Portland, Oregon, United States, 97223
      • Sienna 003
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Site 031
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Site 035
  • Texas
    • Austin, Texas, United States, 78759
      • Sienna 012
    • Dallas, Texas, United States, 75246
      • Sienna 021
    • Houston, Texas, United States, 77030
      • Sienna 018
    • Pflugerville, Texas, United States, 78660
      • Site 034
  • Utah
    • Murray, Utah, United States, 84107
      • Sienna 007
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Sienna 014

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) authorization
• Stable PV for at least 6 months prior to screening
• Chronic pruritus of the PV plaques to be present for at least 6 weeks prior to screening
• Mild to moderate PV at screening and baseline
• Has a target plaque at baseline on the trunk and/or limbs
• Subject's plaques are amenable to treatment with a topical ointment medication
• Willing and able to comply with the study instructions and attend all scheduled study visits.
• Willing to avoid prolonged exposure of the designated treatment plaques to ultraviolet radiation
• Females of childbearing potential must have a negative pregnancy test at baseline before randomization and must agree to use highly effective contraception during the study
• Men who are sexually active and can father 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
• Positive hepatitis serology
• Thyroid abnormalities that may impact itching
• Subjects with spontaneously improving or rapidly deteriorating PV and/or pruritus
• Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
• Active psoriasis or itch affecting the palmar/plantar regions
• Subjects with a clinical diagnosis of bacterial infection of the skin
• Any major medical illness or symptoms of a clinically significant illness that may influence the study outcome
• Any acute chronic medical or psychiatric condition or laboratory abnormality that would make them unsuitable for participation in this study
• Known hypersensitivity to the study treatment excipients and /or polyethylene glycol, that 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 of randomization/baseline (Note: Subjects who are enrolled in a long-term follow-up study and are not actively receiving an investigational drug or investigational device treatment may be eligible for participation in this study)
• Female who is pregnant or lactating, or is planning to become pregnant during the study
• Subjects participating in any previous SNA-120 (and/or CT327) clinical studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle	Drug: Vehicle; Placebo ointment to mimic Pegcantratinib ointment
ACTIVE_COMPARATOR: SNA-120 (0.05% ); Pegcantratinib Ointment	Drug: SNA-120; Pegcantratinib ointment
ACTIVE_COMPARATOR: SNA-120 (0.5%); Pegcantratinib Ointment	Drug: SNA-120; Pegcantratinib ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Itch Numeric Rating Scale scores (I-NRS)	The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching	week 1
Change in Itch Numeric Rating Scale scores (I-NRS)	The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching	week 2
Change in Itch Numeric Rating Scale scores (I-NRS)	The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching	week 4
Change in Itch Numeric Rating Scale scores (I-NRS)	The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching	week 6
Change in Itch Numeric Rating Scale scores (I-NRS)	The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching	week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects (≥ 1 grade change) on IGA scale	Investigator Global Assessment	week 12
Proportion of subjects (≥ 2 grade change) on IGA scale	Investigator Global Assessment	week 12
Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories	Investigator Global Assessment	baseline and week 12
Change in PASI-50	Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index	baseline and week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety measured by incidence and severity of adverse events		up to 12 weeks
Safety measured by change in clinical laboratory results from baseline	urinalysis lab assessments	up to 12 weeks
Safety measured by change in clinical laboratory results from baseline	biochemistry lab assessments	up to 12 weeks
Safety measured by change in clinical laboratory results from baseline	hematology lab assessments	up to 12 weeks
Safety measured by change in blood pressure from baseline	systolic/diastolic blood pressure (BP in mmHg)	up to 12 weeks
Safety measured by change in pulse from baseline	Pulse (beats per minute [bpm])	up to 12 weeks
Safety measured by number of abnormal physical examination changes	Any abnormal physical examination changes from baseline and week 12	baseline and week 12
Safety measured by PR/PQ intervals measured by 12-lead ECG		week 2
Safety measured by PR/PQ intervals measured by 12-lead ECG		week 8
Safety measured by PR/PQ intervals measured by 12-lead ECG		week 12
Safety measured by QRS duration measured by 12-lead ECG		week 2
Safety measured by QRS duration measured by 12-lead ECG		week 8
Safety measured by QRS duration measured by 12-lead ECG		week 12
Safety measured by QT interval measure by 12-lead ECG		week 2
Safety measured by QT interval measure by 12-lead ECG		week 8
Safety measured by QT interval measure by 12-lead ECG		week 12

Collaborators and Investigators

• Sponsor: Sienna Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2017
• Primary Completion (ACTUAL): September 10, 2018
• Study Completion (ACTUAL): October 22, 2018

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (ACTUAL): October 26, 2017

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
• Other Study ID Numbers: SNA-120-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No