Back to resultsSafety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
Primary Purpose
Pruritus, Psoriasis Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SNA-120
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus
Eligibility Criteria
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
Sites / Locations
- Site 025
- Sienna 022
- Site 028
- Sienna 009
- Sienna 008
- Sienna 020
- Sienna 015
- Sienna 005
- Site 030
- Site 026
- Sienna 019
- Sienna 017
- Sienna 024
- Site 027
- Site 029
- Sienna 010
- Sienna 011
- Sienna 023
- Site 038
- Site 032
- Site 039
- Sienna 002
- Sienna 001
- Sienna 004
- Sienna 013
- Site 037
- Sienna 016
- Sienna 006
- Site 041
- Sienna 003
- Site 031
- Site 035
- Sienna 012
- Sienna 021
- Sienna 018
- Site 034
- Sienna 007
- Sienna 014
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
SNA-120 (0.05% )
SNA-120 (0.5%)
Vehicle
Arm Description
Pegcantratinib Ointment
Pegcantratinib Ointment
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
Proportion of subjects (≥ 1 grade change) on IGA scale
Investigator Global Assessment
Proportion of subjects (≥ 2 grade change) on IGA scale
Investigator Global Assessment
Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories
Investigator Global Assessment
Change in PASI-50
Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index
Full Information
NCT ID
NCT03322137
First Posted
October 4, 2017
Last Updated
February 4, 2019
Sponsor
Sienna Biopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03322137
Brief Title
Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
September 10, 2018 (Actual)
Study Completion Date
October 22, 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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SNA-120 (0.05% )
Arm Type
Active Comparator
Arm Description
Pegcantratinib Ointment
Arm Title
SNA-120 (0.5%)
Arm Type
Active Comparator
Arm Description
Pegcantratinib Ointment
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SNA-120
Intervention Description
Pegcantratinib ointment
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Placebo ointment to mimic Pegcantratinib ointment
Primary Outcome Measure Information:
Title
Change in Itch Numeric Rating Scale scores (I-NRS)
Description
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time Frame
week 1
Title
Change in Itch Numeric Rating Scale scores (I-NRS)
Description
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time Frame
week 2
Title
Change in Itch Numeric Rating Scale scores (I-NRS)
Description
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time Frame
week 4
Title
Change in Itch Numeric Rating Scale scores (I-NRS)
Description
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time Frame
week 6
Title
Change in Itch Numeric Rating Scale scores (I-NRS)
Description
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Proportion of subjects (≥ 1 grade change) on IGA scale
Description
Investigator Global Assessment
Time Frame
week 12
Title
Proportion of subjects (≥ 2 grade change) on IGA scale
Description
Investigator Global Assessment
Time Frame
week 12
Title
Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories
Description
Investigator Global Assessment
Time Frame
baseline and week 12
Title
Change in PASI-50
Description
Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index
Time Frame
baseline and week 12
Other Pre-specified Outcome Measures:
Title
Safety measured by incidence and severity of adverse events
Time Frame
up to 12 weeks
Title
Safety measured by change in clinical laboratory results from baseline
Description
urinalysis lab assessments
Time Frame
up to 12 weeks
Title
Safety measured by change in clinical laboratory results from baseline
Description
biochemistry lab assessments
Time Frame
up to 12 weeks
Title
Safety measured by change in clinical laboratory results from baseline
Description
hematology lab assessments
Time Frame
up to 12 weeks
Title
Safety measured by change in blood pressure from baseline
Description
systolic/diastolic blood pressure (BP in mmHg)
Time Frame
up to 12 weeks
Title
Safety measured by change in pulse from baseline
Description
Pulse (beats per minute [bpm])
Time Frame
up to 12 weeks
Title
Safety measured by number of abnormal physical examination changes
Description
Any abnormal physical examination changes from baseline and week 12
Time Frame
baseline and week 12
Title
Safety measured by PR/PQ intervals measured by 12-lead ECG
Time Frame
week 2
Title
Safety measured by PR/PQ intervals measured by 12-lead ECG
Time Frame
week 8
Title
Safety measured by PR/PQ intervals measured by 12-lead ECG
Time Frame
week 12
Title
Safety measured by QRS duration measured by 12-lead ECG
Time Frame
week 2
Title
Safety measured by QRS duration measured by 12-lead ECG
Time Frame
week 8
Title
Safety measured by QRS duration measured by 12-lead ECG
Time Frame
week 12
Title
Safety measured by QT interval measure by 12-lead ECG
Time Frame
week 2
Title
Safety measured by QT interval measure by 12-lead ECG
Time Frame
week 8
Title
Safety measured by QT interval measure by 12-lead ECG
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Site 025
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Sienna 022
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Site 028
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Sienna 009
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Sienna 008
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sienna 020
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Sienna 015
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Sienna 005
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Site 030
City
Shelton
State/Province
Connecticut
ZIP/Postal Code
06484
Country
United States
Facility Name
Site 026
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Sienna 019
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Sienna 017
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Sienna 024
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Site 027
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Site 029
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Sienna 010
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Sienna 011
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Sienna 023
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Site 038
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Site 032
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Site 039
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Sienna 002
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Sienna 001
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Sienna 004
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Sienna 013
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Site 037
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Sienna 016
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27626
Country
United States
Facility Name
Sienna 006
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Site 041
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Sienna 003
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Site 031
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Site 035
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Sienna 012
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Sienna 021
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Sienna 018
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site 034
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Sienna 007
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Sienna 014
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris
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