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

NCT03322137 | Completed Phase 2 FDA Drug

• 1 other identifier: SNA-120-201
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 38

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.

Conditions

Pruritus; Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (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

  week 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

  week 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

  week 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

  week 6

• 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

  week 8

Secondary Outcomes (4)

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

  week 12

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

  week 12

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

  baseline and week 12

• Change in PASI-50

  baseline and week 12

Other Outcomes (16)

• Safety measured by incidence and severity of adverse events

  up to 12 weeks

• Safety measured by change in clinical laboratory results from baseline

  up to 12 weeks

• Safety measured by change in clinical laboratory results from baseline

  up to 12 weeks

Study Arms (3)

SNA-120 (0.05% )

ACTIVE COMPARATOR

Pegcantratinib Ointment

Drug: SNA-120

SNA-120 (0.5%)

ACTIVE COMPARATOR

Pegcantratinib Ointment

Drug: SNA-120

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

SNA-120 DRUG

Pegcantratinib ointment

SNA-120 (0.05% ); SNA-120 (0.5%)

Vehicle DRUG

Placebo ointment to mimic Pegcantratinib ointment

Vehicle

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sienna Biopharmaceuticals: lead

Study Sites (38)

Site 025

Scottsdale, Arizona, 85255, United States

Location

Sienna 022

Fort Smith, Arkansas, 72916, United States

Location

Site 028

Fountain Valley, California, 92708, United States

Location

Sienna 009

Fremont, California, 94538, United States

Location

Sienna 008

San Diego, California, 92123, United States

Location

Sienna 020

Santa Monica, California, 90404, United States

Location

Sienna 015

Denver, Colorado, 80220, United States

Location

Sienna 005

Farmington, Connecticut, 06032, United States

Location

Site 030

Shelton, Connecticut, 06484, United States

Location

Site 026

Doral, Florida, 33122, United States

Location

Sienna 019

Largo, Florida, 33770, United States

Location

Sienna 017

North Miami Beach, Florida, 33162, United States

Location

Sienna 024

Ocala, Florida, 34471, United States

Location

Site 027

West Palm Beach, Florida, 33406, United States

Location

Site 029

Macon, Georgia, 31217, United States

Location

Sienna 010

New Albany, Indiana, 47150, United States

Location

Sienna 011

Plainfield, Indiana, 46168, United States

Location

Sienna 023

Louisville, Kentucky, 40202, United States

Location

Site 038

Metairie, Louisiana, 70006, United States

Location

Site 032

Rockville, Maryland, 20850, United States

Location

Site 039

Clarkston, Michigan, 48346, United States

Location

Sienna 002

Fridley, Minnesota, 55432, United States

Location

Sienna 001

St Louis, Missouri, 63117, United States

Location

Sienna 004

East Windsor, New Jersey, 08520, United States

Location

Sienna 013

Albuquerque, New Mexico, 87106, United States

Location

Site 037

Rochester, New York, 14623, United States

Location

Sienna 016

High Point, North Carolina, 27626, United States

Location

Sienna 006

Winston-Salem, North Carolina, 27104, United States

Location

Site 041

Norman, Oklahoma, 73071, United States

Location

Sienna 003

Portland, Oregon, 97223, United States

Location

Site 031

Pittsburgh, Pennsylvania, 15213, United States

Location

Site 035

Murfreesboro, Tennessee, 37130, United States

Location

Sienna 012

Austin, Texas, 78759, United States

Location

Sienna 021

Dallas, Texas, 75246, United States

Location

Sienna 018

Houston, Texas, 77030, United States

Location

Site 034

Pflugerville, Texas, 78660, United States

Location

Sienna 007

Murray, Utah, 84107, United States

Location

Sienna 014

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 26, 2017
• Study Start: October 10, 2017
• Primary Completion: September 10, 2018
• Study Completion: October 22, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

US (38)