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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322137
• Other study ID #: SNA-120-201
• Status: Completed
• Phase: Phase 2
• Start date: October 10, 2017
• Est. completion date: October 22, 2018

Study information

• Verified date: February 2019
• Source: Sienna Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 22, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pruritus
• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• SNA-120
Pegcantratinib ointment
• Vehicle
Placebo ointment to mimic Pegcantratinib ointment

Locations

Country	Name	City	State
United States	Sienna 013	Albuquerque	New Mexico
United States	Sienna 012	Austin	Texas
United States	Site 039	Clarkston	Michigan
United States	Sienna 021	Dallas	Texas
United States	Sienna 015	Denver	Colorado
United States	Site 026	Doral	Florida
United States	Sienna 004	East Windsor	New Jersey
United States	Sienna 005	Farmington	Connecticut
United States	Sienna 022	Fort Smith	Arkansas
United States	Site 028	Fountain Valley	California
United States	Sienna 009	Fremont	California
United States	Sienna 002	Fridley	Minnesota
United States	Sienna 016	High Point	North Carolina
United States	Sienna 018	Houston	Texas
United States	Sienna 019	Largo	Florida
United States	Sienna 023	Louisville	Kentucky
United States	Site 029	Macon	Georgia
United States	Site 038	Metairie	Louisiana
United States	Site 035	Murfreesboro	Tennessee
United States	Sienna 007	Murray	Utah
United States	Sienna 010	New Albany	Indiana
United States	Sienna 014	Norfolk	Virginia
United States	Site 041	Norman	Oklahoma
United States	Sienna 017	North Miami Beach	Florida
United States	Sienna 024	Ocala	Florida
United States	Site 034	Pflugerville	Texas
United States	Site 031	Pittsburgh	Pennsylvania
United States	Sienna 011	Plainfield	Indiana
United States	Sienna 003	Portland	Oregon
United States	Site 037	Rochester	New York
United States	Site 032	Rockville	Maryland
United States	Sienna 001	Saint Louis	Missouri
United States	Sienna 008	San Diego	California
United States	Sienna 020	Santa Monica	California
United States	Site 025	Scottsdale	Arizona
United States	Site 030	Shelton	Connecticut
United States	Site 027	West Palm Beach	Florida
United States	Sienna 006	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sienna Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety measured by incidence and severity of adverse events		up to 12 weeks
Other	Safety measured by change in clinical laboratory results from baseline	urinalysis lab assessments	up to 12 weeks
Other	Safety measured by change in clinical laboratory results from baseline	biochemistry lab assessments	up to 12 weeks
Other	Safety measured by change in clinical laboratory results from baseline	hematology lab assessments	up to 12 weeks
Other	Safety measured by change in blood pressure from baseline	systolic/diastolic blood pressure (BP in mmHg)	up to 12 weeks
Other	Safety measured by change in pulse from baseline	Pulse (beats per minute [bpm])	up to 12 weeks
Other	Safety measured by number of abnormal physical examination changes	Any abnormal physical examination changes from baseline and week 12	baseline and week 12
Other	Safety measured by PR/PQ intervals measured by 12-lead ECG		week 2
Other	Safety measured by PR/PQ intervals measured by 12-lead ECG		week 8
Other	Safety measured by PR/PQ intervals measured by 12-lead ECG		week 12
Other	Safety measured by QRS duration measured by 12-lead ECG		week 2
Other	Safety measured by QRS duration measured by 12-lead ECG		week 8
Other	Safety measured by QRS duration measured by 12-lead ECG		week 12
Other	Safety measured by QT interval measure by 12-lead ECG		week 2
Other	Safety measured by QT interval measure by 12-lead ECG		week 8
Other	Safety measured by QT interval measure by 12-lead ECG		week 12
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Proportion of subjects (= 1 grade change) on IGA scale	Investigator Global Assessment	week 12
Secondary	Proportion of subjects (= 2 grade change) on IGA scale	Investigator Global Assessment	week 12
Secondary	Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories	Investigator Global Assessment	baseline and week 12
Secondary	Change in PASI-50	Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index	baseline and week 12