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CompletedNCT03448081Updated Feb 8, 2019

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

A Phase 2 interventional study of SNA-120 and Placebo in Pruritus and Psoriasis, sponsored by Sienna Biopharmaceuticals. Completed at 20 sites in 2 countries. Open to participants aged 18 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
73
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pruritus
  • Psoriasis
03

Who can participate

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

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

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
04

Study design

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

Study arms

  • Active comparator
    SNA-120 + Calcipotriene

    Drug: SNA-120 · Drug: Calcipotriene

  • Placebo comparator
    Placebo + Calcipotriene

    Drug: Placebo · Drug: Calcipotriene

Interventions

  • DrugSNA-120

    SNA-120 (0.5%) active ointment

  • DrugPlacebo

    Vehicle Ointment

  • DrugCalcipotriene

    Calcipotriene ointment (0.005%)

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: week 8

Secondary outcomes

  1. 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)

    Time frame: week 8

  2. 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)

    Time frame: week 8

Other outcomes

  1. 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

    Time frame: week 10

  2. 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

    Time frame: week 10

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

    biochemistry lab assessments

    Time frame: week 10

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

    Clinical laboratory assessments include urinalysis (pH, glucose, protein)

    Time frame: week 10

  5. Safety measured by change in clinical lab results from baseline

    hematology lab assessments

    Time frame: week 10

  6. 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

    Time frame: week 10

  7. Safety measured by change from baseline in pulse

    Measured in beats per minute (bpm) - measured every full clinic visit, from baseline through week 10

    Time frame: week 10

  8. Safety measured by number of abnormal physical examinations from baseline

    Time frame: week 8

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

    Safety measured by PR/PQ intervals measured by 12-lead ECG at screening

    Time frame: week -4

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

    Safety measured by PR/PQ intervals measured by 12-lead ECG at baseline

    Time frame: week 0

  11. 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

    Time frame: week 4

  12. 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

    Time frame: week 8

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

    Safety measured by QRS duration measured by 12-lead ECG at screening

    Time frame: week -4

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

    Safety measured by QRS duration measured by 12-lead ECG at baseline

    Time frame: week 0

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

    Safety measured by QRS duration measured by 12-lead ECG at week 4

    Time frame: week 4

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

    Safety measured by QRS duration measured by 12-lead ECG at week 8

    Time frame: week 8

  17. Safety measured by QT intervals measured by 12-lead ECG

    Safety measured by QT intervals measured by 12-lead ECG at screening

    Time frame: week -4

  18. Safety measured by QT intervals measured by 12-lead ECG

    Safety measured by QT intervals measured by 12-lead ECG at baseline

    Time frame: week 0

  19. Safety measured by QT intervals measured by 12-lead ECG

    Safety measured by QT intervals measured by 12-lead ECG at week 4

    Time frame: week 4

  20. Safety measured by QT intervals measured by 12-lead ECG

    Safety measured by QT intervals measured by 12-lead ECG at week 8

    Time frame: week 8

06

Study locations

20 sites
  • Sienna 018
    Anniston, Alabama 36207, United States
  • Sienna 009
    Mobile, Alabama 36608, United States
  • Sienna 019
    Fountain Valley, California 92708, United States
  • Sienna 007
    Los Angeles, California 90045, United States
  • Site 016
    Sherman Oaks, California 91403, United States
  • Site 013
    Coral Gables, Florida 33143, United States
  • Site 015
    Sanford, Florida 32771, United States
  • Site 012
    Indianapolis, Indiana 46256, United States
  • Sienna 011
    Warren, Michigan 48088, United States
  • Sienna 005
    Berlin, New Jersey 08009, United States
  • Sienna 020
    Rochester, New York 14623, United States
  • Site 014
    Raleigh, North Carolina 27612, United States
  • Sienna 002
    Oklahoma City, Oklahoma 73118, United States
  • Sienna 017
    Austin, Texas 78745, United States
  • Sienna 010
    Houston, Texas 77004, United States
  • Sienna 021
    Pflugerville, Texas 78660, United States
  • Sienna 001
    San Antonio, Texas 78213, United States
  • Sienna 006
    Surrey, British Columbia V3R 6A7, Canada
  • Sienna 008
    Peterborough, Ontario K9J 5K2, Canada
  • Sienna 003
    Montreal, Quebec H2K 4L5, Canada
07

Registry details

Key details

Study ID
NCT03448081
Lead sponsor
Sienna Biopharmaceuticals
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Feb 12, 2018
Primary completion
Nov 21, 2018
Completion
Dec 10, 2018
Last update
Feb 8, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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