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A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when administered topically with calcipotriene ointment for the treatment of pruritus and psoriasis.
All subjects are required to meet eligibility requirements and undergo a calcipotriene run-in period (Part A) prior to qualifying and randomizing into the study to receive either SNA-120 or Placebo ointment in combination with calcipotriene ointment (Part B). Combination therapy (SNA-120 ointment + calcipotriene ointment or Placebo ointment + calcipotriene ointment) is to continue over an 8 week period to evaluate safety, tolerability and the efficacy of treatment on both persistent pruritus and the visible signs and symptoms of psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNA-120 + Calcipotriene | Active Comparator |
| |
| Placebo + Calcipotriene | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNA-120 | Drug | SNA-120 (0.5%) active ointment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Itch Numeric Rating Scale scores (I-NRS) from baseline | 11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching) | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Investigator Global Assessment (IGA) from baseline | 5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe) | week 8 |
| Change in Psoriasis Area Severity Index (PASI) from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by frequency of Adverse Events | Frequency of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10 | week 10 |
| Safety measured by severity of Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sienna 018 | Anniston | Alabama | 36207 | United States | ||
| Sienna 009 |
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| Placebo |
| Drug |
Vehicle Ointment |
|
| Calcipotriene | Drug | Calcipotriene ointment (0.005%) |
|
A quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance (0 = no disease to 72 = maximum disease) |
| week 8 |
Severity of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10
| week 10 |
| Safety measured by change in clinical lab results from baseline | biochemistry lab assessments | week 10 |
| Safety measured by change in clinical lab results from baseline | Clinical laboratory assessments include urinalysis (pH, glucose, protein) | week 10 |
| Safety measured by change in clinical lab results from baseline | hematology lab assessments | week 10 |
| Safety measured by change from baseline in blood pressure | Systolic/diastolic blood pressure (BP in mmHg) - measured every full clinic visit, from baseline through week 10 | week 10 |
| Safety measured by change from baseline in pulse | Measured in beats per minute (bpm) - measured every full clinic visit, from baseline through week 10 | week 10 |
| Safety measured by number of abnormal physical examinations from baseline | week 8 |
| Safety measured by PR/PQ intervals measured by 12-lead ECG | Safety measured by PR/PQ intervals measured by 12-lead ECG at screening | week -4 |
| Safety measured by PR/PQ intervals measured by 12-lead ECG | Safety measured by PR/PQ intervals measured by 12-lead ECG at baseline | week 0 |
| Safety measured by PR/PQ intervals measured by 12-lead ECG | Safety measured by PR/PQ intervals measured by 12-lead ECG at week 4 | week 4 |
| Safety measured by PR/PQ intervals measured by 12-lead ECG | Safety measured by PR/PQ intervals measured by 12-lead ECG at week 8 | week 8 |
| Safety measured by QRS duration measured by 12-lead ECG | Safety measured by QRS duration measured by 12-lead ECG at screening | week -4 |
| Safety measured by QRS duration measured by 12-lead ECG | Safety measured by QRS duration measured by 12-lead ECG at baseline | week 0 |
| Safety measured by QRS duration measured by 12-lead ECG | Safety measured by QRS duration measured by 12-lead ECG at week 4 | week 4 |
| Safety measured by QRS duration measured by 12-lead ECG | Safety measured by QRS duration measured by 12-lead ECG at week 8 | week 8 |
| Safety measured by QT intervals measured by 12-lead ECG | Safety measured by QT intervals measured by 12-lead ECG at screening | week -4 |
| Safety measured by QT intervals measured by 12-lead ECG | Safety measured by QT intervals measured by 12-lead ECG at baseline | week 0 |
| Safety measured by QT intervals measured by 12-lead ECG | Safety measured by QT intervals measured by 12-lead ECG at week 4 | week 4 |
| Safety measured by QT intervals measured by 12-lead ECG | Safety measured by QT intervals measured by 12-lead ECG at week 8 | week 8 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Sienna 019 | Fountain Valley | California | 92708 | United States |
| Sienna 007 | Los Angeles | California | 90045 | United States |
| Site 016 | Sherman Oaks | California | 91403 | United States |
| Site 013 | Coral Gables | Florida | 33143 | United States |
| Site 015 | Sanford | Florida | 32771 | United States |
| Site 012 | Indianapolis | Indiana | 46256 | United States |
| Sienna 011 | Warren | Michigan | 48088 | United States |
| Sienna 005 | Berlin | New Jersey | 08009 | United States |
| Sienna 020 | Rochester | New York | 14623 | United States |
| Site 014 | Raleigh | North Carolina | 27612 | United States |
| Sienna 002 | Oklahoma City | Oklahoma | 73118 | United States |
| Sienna 017 | Austin | Texas | 78745 | United States |
| Sienna 010 | Houston | Texas | 77004 | United States |
| Sienna 021 | Pflugerville | Texas | 78660 | United States |
| Sienna 001 | San Antonio | Texas | 78213 | United States |
| Sienna 006 | Surrey | British Columbia | V3R 6A7 | Canada |
| Sienna 008 | Peterborough | Ontario | K9J 5K2 | Canada |
| Sienna 003 | Montreal | Quebec | H2K 4L5 | Canada |
| ID | Term |
|---|---|
| D011537 | Pruritus |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017444 | Skin Diseases, Papulosquamous |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
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