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

Primary Purpose

Pruritus, Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SNA-120
Placebo
Calcipotriene
Sponsored by
Sienna Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sienna 018
  • Sienna 009
  • Sienna 019
  • Sienna 007
  • Site 016
  • Site 013
  • Site 015
  • Site 012
  • Sienna 011
  • Sienna 005
  • Sienna 020
  • Site 014
  • Sienna 002
  • Sienna 017
  • Sienna 010
  • Sienna 021
  • Sienna 001
  • Sienna 006
  • Sienna 008
  • Sienna 003

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SNA-120 + Calcipotriene

Placebo + Calcipotriene

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)

Full Information

First Posted
February 14, 2018
Last Updated
February 4, 2019
Sponsor
Sienna Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03448081
Brief Title
Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene
Official Title
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
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sienna Biopharmaceuticals

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SNA-120 + Calcipotriene
Arm Type
Active Comparator
Arm Title
Placebo + Calcipotriene
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SNA-120
Intervention Description
SNA-120 (0.5%) active ointment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle Ointment
Intervention Type
Drug
Intervention Name(s)
Calcipotriene
Intervention Description
Calcipotriene ointment (0.005%)
Primary Outcome Measure Information:
Title
Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
Description
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 Outcome Measure Information:
Title
Change in Investigator Global Assessment (IGA) from baseline
Description
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
Title
Change in Psoriasis Area Severity Index (PASI) from baseline
Description
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 Pre-specified Outcome Measures:
Title
Safety measured by frequency of Adverse Events
Description
Frequency of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10
Time Frame
week 10
Title
Safety measured by severity of Adverse Events
Description
Severity of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10
Time Frame
week 10
Title
Safety measured by change in clinical lab results from baseline
Description
biochemistry lab assessments
Time Frame
week 10
Title
Safety measured by change in clinical lab results from baseline
Description
Clinical laboratory assessments include urinalysis (pH, glucose, protein)
Time Frame
week 10
Title
Safety measured by change in clinical lab results from baseline
Description
hematology lab assessments
Time Frame
week 10
Title
Safety measured by change from baseline in blood pressure
Description
Systolic/diastolic blood pressure (BP in mmHg) - measured every full clinic visit, from baseline through week 10
Time Frame
week 10
Title
Safety measured by change from baseline in pulse
Description
Measured in beats per minute (bpm) - measured every full clinic visit, from baseline through week 10
Time Frame
week 10
Title
Safety measured by number of abnormal physical examinations from baseline
Time Frame
week 8
Title
Safety measured by PR/PQ intervals measured by 12-lead ECG
Description
Safety measured by PR/PQ intervals measured by 12-lead ECG at screening
Time Frame
week -4
Title
Safety measured by PR/PQ intervals measured by 12-lead ECG
Description
Safety measured by PR/PQ intervals measured by 12-lead ECG at baseline
Time Frame
week 0
Title
Safety measured by PR/PQ intervals measured by 12-lead ECG
Description
Safety measured by PR/PQ intervals measured by 12-lead ECG at week 4
Time Frame
week 4
Title
Safety measured by PR/PQ intervals measured by 12-lead ECG
Description
Safety measured by PR/PQ intervals measured by 12-lead ECG at week 8
Time Frame
week 8
Title
Safety measured by QRS duration measured by 12-lead ECG
Description
Safety measured by QRS duration measured by 12-lead ECG at screening
Time Frame
week -4
Title
Safety measured by QRS duration measured by 12-lead ECG
Description
Safety measured by QRS duration measured by 12-lead ECG at baseline
Time Frame
week 0
Title
Safety measured by QRS duration measured by 12-lead ECG
Description
Safety measured by QRS duration measured by 12-lead ECG at week 4
Time Frame
week 4
Title
Safety measured by QRS duration measured by 12-lead ECG
Description
Safety measured by QRS duration measured by 12-lead ECG at week 8
Time Frame
week 8
Title
Safety measured by QT intervals measured by 12-lead ECG
Description
Safety measured by QT intervals measured by 12-lead ECG at screening
Time Frame
week -4
Title
Safety measured by QT intervals measured by 12-lead ECG
Description
Safety measured by QT intervals measured by 12-lead ECG at baseline
Time Frame
week 0
Title
Safety measured by QT intervals measured by 12-lead ECG
Description
Safety measured by QT intervals measured by 12-lead ECG at week 4
Time Frame
week 4
Title
Safety measured by QT intervals measured by 12-lead ECG
Description
Safety measured by QT intervals measured by 12-lead ECG at week 8
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sienna 018
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Sienna 009
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Sienna 019
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Sienna 007
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Site 016
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Site 013
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Site 015
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Site 012
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Sienna 011
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Sienna 005
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Sienna 020
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Site 014
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Sienna 002
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Sienna 017
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Sienna 010
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Sienna 021
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Sienna 001
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Sienna 006
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Sienna 008
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Sienna 003
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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