Clinical trial NCT03322137: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus
Psoriasis Vulgaris
Lead sponsor: Sienna Labs
Sponsor class: INDUSTRY
First posted: 2017-10-26
Enrollment: 208
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Itch Numeric Rating Scale scores (I-NRS)
timeFrame: week 1
measure: Change in Itch Numeric Rating Scale scores (I-NRS)
timeFrame: week 2
measure: Change in Itch Numeric Rating Scale scores (I-NRS)
timeFrame: week 4
measure: Change in Itch Numeric Rating Scale scores (I-NRS)
timeFrame: week 6
measure: Change in Itch Numeric Rating Scale scores (I-NRS)
timeFrame: week 8
Secondary outcomes:
measure: Proportion of subjects (≥ 1 grade change) on IGA scale
timeFrame: week 12
measure: Proportion of subjects (≥ 2 grade change) on IGA scale
timeFrame: week 12
measure: Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories
timeFrame: baseline and week 12
measure: Change in PASI-50
timeFrame: baseline and week 12
Other outcomes:
measure: Safety measured by incidence and severity of adverse events
timeFrame: up to 12 weeks
measure: Safety measured by change in clinical laboratory results from baseline
timeFrame: up to 12 weeks
measure: Safety measured by change in clinical laboratory results from baseline
timeFrame: up to 12 weeks
measure: Safety measured by change in clinical laboratory results from baseline
timeFrame: up to 12 weeks
measure: Safety measured by change in blood pressure from baseline
timeFrame: up to 12 weeks
measure: Safety measured by change in pulse from baseline
timeFrame: up to 12 weeks
measure: Safety measured by number of abnormal physical examination changes
timeFrame: baseline and week 12
measure: Safety measured by PR/PQ intervals measured by 12-lead ECG
timeFrame: week 2
measure: Safety measured by PR/PQ intervals measured by 12-lead ECG
timeFrame: week 8
measure: Safety measured by PR/PQ intervals measured by 12-lead ECG
timeFrame: week 12
measure: Safety measured by QRS duration measured by 12-lead ECG
timeFrame: week 2
measure: Safety measured by QRS duration measured by 12-lead ECG
timeFrame: week 8
measure: Safety measured by QRS duration measured by 12-lead ECG
timeFrame: week 12
measure: Safety measured by QT interval measure by 12-lead ECG
timeFrame: week 2
measure: Safety measured by QT interval measure by 12-lead ECG
timeFrame: week 8
measure: Safety measured by QT interval measure by 12-lead ECG
timeFrame: week 12
Locations:
city: Scottsdale
country: United States
facility: Site 025
state: Arizona
city: Fort Smith
country: United States
facility: Sienna 022
state: Arkansas
city: Fountain Valley
country: United States
facility: Site 028
state: California
city: Fremont
country: United States
facility: Sienna 009
state: California
city: San Diego
country: United States
facility: Sienna 008
state: California
city: Santa Monica
country: United States
facility: Sienna 020
state: California
city: Denver
country: United States
facility: Sienna 015
state: Colorado
city: Farmington
country: United States
facility: Sienna 005
state: Connecticut
city: Shelton
country: United States
facility: Site 030
state: Connecticut
city: Doral
country: United States
facility: Site 026
state: Florida
city: Largo
country: United States
facility: Sienna 019
state: Florida
city: North Miami Beach
country: United States
facility: Sienna 017
state: Florida
city: Ocala
country: United States
facility: Sienna 024
state: Florida
city: West Palm Beach
country: United States
facility: Site 027
state: Florida
city: Macon
country: United States
facility: Site 029
state: Georgia
city: New Albany
country: United States
facility: Sienna 010
state: Indiana
city: Plainfield
country: United States
facility: Sienna 011
state: Indiana
city: Louisville
country: United States
facility: Sienna 023
state: Kentucky
city: Metairie
country: United States
facility: Site 038
state: Louisiana
city: Rockville
country: United States
facility: Site 032
state: Maryland
city: Clarkston
country: United States
facility: Site 039
state: Michigan
city: Fridley
country: United States
facility: Sienna 002
state: Minnesota
city: Saint Louis
country: United States
facility: Sienna 001
state: Missouri
city: East Windsor
country: United States
facility: Sienna 004
state: New Jersey
city: Albuquerque
country: United States
facility: Sienna 013
state: New Mexico
city: Rochester
country: United States
facility: Site 037
state: New York
city: High Point
country: United States
facility: Sienna 016
state: North Carolina
city: Winston-Salem
country: United States
facility: Sienna 006
state: North Carolina
city: Norman
country: United States
facility: Site 041
state: Oklahoma
city: Portland
country: United States
facility: Sienna 003
state: Oregon
city: Pittsburgh
country: United States
facility: Site 031
state: Pennsylvania
city: Murfreesboro
country: United States
facility: Site 035
state: Tennessee
city: Austin
country: United States
facility: Sienna 012
state: Texas
city: Dallas
country: United States
facility: Sienna 021
state: Texas
city: Houston
country: United States
facility: Sienna 018
state: Texas
city: Pflugerville
country: United States
facility: Site 034
state: Texas
city: Murray
country: United States
facility: Sienna 007
state: Utah
city: Norfolk
country: United States
facility: Sienna 014
state: Virginia
Study officials:
References: