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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03322137
Other study ID # SNA-120-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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