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
Verified date | February 2019 |
Source | Sienna Labs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Sienna Biopharmaceuticals |
United States,
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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