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CompletedNCT03322137Updated Feb 8, 2019

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

A Phase 2 interventional study of SNA-120 and Vehicle in Pruritus and Psoriasis Vulgaris, sponsored by Sienna Biopharmaceuticals. Completed at 38 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by Sienna Biopharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
208
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pruritus
  • Psoriasis Vulgaris
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
208 participants (actual)

Study arms

  • Active comparator
    SNA-120 (0.05% )

    Pegcantratinib Ointment

    Drug: SNA-120

  • Active comparator
    SNA-120 (0.5%)

    Pegcantratinib Ointment

    Drug: SNA-120

  • Placebo comparator
    Vehicle

    Drug: Vehicle

Interventions

  • DrugSNA-120

    Pegcantratinib ointment

  • DrugVehicle

    Placebo ointment to mimic Pegcantratinib ointment

05

What researchers measure

Primary outcomes

  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

    Time frame: week 1

  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

    Time frame: week 2

  3. 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

    Time frame: week 4

  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

    Time frame: week 6

  5. 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

    Time frame: week 8

Secondary outcomes

  1. Proportion of subjects (≥ 1 grade change) on IGA scale

    Investigator Global Assessment

    Time frame: week 12

  2. Proportion of subjects (≥ 2 grade change) on IGA scale

    Investigator Global Assessment

    Time frame: week 12

  3. Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories

    Investigator Global Assessment

    Time frame: baseline and week 12

  4. Change in PASI-50

    Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index

    Time frame: baseline and week 12

Other outcomes

  1. Safety measured by incidence and severity of adverse events

    Time frame: up to 12 weeks

  2. Safety measured by change in clinical laboratory results from baseline

    urinalysis lab assessments

    Time frame: up to 12 weeks

  3. Safety measured by change in clinical laboratory results from baseline

    biochemistry lab assessments

    Time frame: up to 12 weeks

  4. Safety measured by change in clinical laboratory results from baseline

    hematology lab assessments

    Time frame: up to 12 weeks

  5. Safety measured by change in blood pressure from baseline

    systolic/diastolic blood pressure (BP in mmHg)

    Time frame: up to 12 weeks

  6. Safety measured by change in pulse from baseline

    Pulse (beats per minute \[bpm\])

    Time frame: up to 12 weeks

  7. Safety measured by number of abnormal physical examination changes

    Any abnormal physical examination changes from baseline and week 12

    Time frame: baseline and week 12

  8. Safety measured by PR/PQ intervals measured by 12-lead ECG

    Time frame: week 2

  9. Safety measured by PR/PQ intervals measured by 12-lead ECG

    Time frame: week 8

  10. Safety measured by PR/PQ intervals measured by 12-lead ECG

    Time frame: week 12

  11. Safety measured by QRS duration measured by 12-lead ECG

    Time frame: week 2

  12. Safety measured by QRS duration measured by 12-lead ECG

    Time frame: week 8

  13. Safety measured by QRS duration measured by 12-lead ECG

    Time frame: week 12

  14. Safety measured by QT interval measure by 12-lead ECG

    Time frame: week 2

  15. Safety measured by QT interval measure by 12-lead ECG

    Time frame: week 8

  16. Safety measured by QT interval measure by 12-lead ECG

    Time frame: week 12

06

Study locations

38 sites
  • Site 025
    Scottsdale, Arizona 85255, United States
  • Sienna 022
    Fort Smith, Arkansas 72916, United States
  • Site 028
    Fountain Valley, California 92708, United States
  • Sienna 009
    Fremont, California 94538, United States
  • Sienna 008
    San Diego, California 92123, United States
  • Sienna 020
    Santa Monica, California 90404, United States
  • Sienna 015
    Denver, Colorado 80220, United States
  • Sienna 005
    Farmington, Connecticut 06032, United States
  • Site 030
    Shelton, Connecticut 06484, United States
  • Site 026
    Doral, Florida 33122, United States
  • Sienna 019
    Largo, Florida 33770, United States
  • Sienna 017
    North Miami Beach, Florida 33162, United States
  • Sienna 024
    Ocala, Florida 34471, United States
  • Site 027
    West Palm Beach, Florida 33406, United States
  • Site 029
    Macon, Georgia 31217, United States
  • Sienna 010
    New Albany, Indiana 47150, United States
  • Sienna 011
    Plainfield, Indiana 46168, United States
  • Sienna 023
    Louisville, Kentucky 40202, United States
  • Site 038
    Metairie, Louisiana 70006, United States
  • Site 032
    Rockville, Maryland 20850, United States
  • Site 039
    Clarkston, Michigan 48346, United States
  • Sienna 002
    Fridley, Minnesota 55432, United States
  • Sienna 001
    Saint Louis, Missouri 63117, United States
  • Sienna 004
    East Windsor, New Jersey 08520, United States
  • Sienna 013
    Albuquerque, New Mexico 87106, United States
  • Site 037
    Rochester, New York 14623, United States
  • Sienna 016
    High Point, North Carolina 27626, United States
  • Sienna 006
    Winston-Salem, North Carolina 27104, United States
  • Site 041
    Norman, Oklahoma 73071, United States
  • Sienna 003
    Portland, Oregon 97223, United States
  • Site 031
    Pittsburgh, Pennsylvania 15213, United States
  • Site 035
    Murfreesboro, Tennessee 37130, United States
  • Sienna 012
    Austin, Texas 78759, United States
  • Sienna 021
    Dallas, Texas 75246, United States
  • Sienna 018
    Houston, Texas 77030, United States
  • Site 034
    Pflugerville, Texas 78660, United States
  • Sienna 007
    Murray, Utah 84107, United States
  • Sienna 014
    Norfolk, Virginia 23502, United States
07

Registry details

Key details

Study ID
NCT03322137
Lead sponsor
Sienna Biopharmaceuticals
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Oct 10, 2017
Primary completion
Sep 10, 2018
Completion
Oct 22, 2018
Last update
Feb 8, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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