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The study is designed to investigate efficacy and safety of KBL697 in patients with Moderate Plaque Type Psoriasis. KBL697 has been developed as a potential new treatment for Psoriatic Plaque.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose group | Experimental | 39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo. |
|
| High dose group | Experimental | 39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KBL697 | Drug | 1 capsule BID of KBL697 or Placebo |
| |
| KBL697 |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) | Change from Baseline in PASI score | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) | Change from Baseline in PASI score | Baseline to Weeks 2, 4 and 8 |
| Psoriasis Area and Severity Index (PASI) -50 | Percent of patients who achieved PASI-50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ira Thorla | Louisiana Dermatology Associates | Principal Investigator |
| Jose Cardona | Indago Research and Health Center | Principal Investigator |
| Jennifer Soung | Southern California Dermatology, Inc | Principal Investigator |
| James Krell | Total Skin and Beauty Dermatology Center | Principal Investigator |
| Paul Yamauchi | Clinical Science Institute | Principal Investigator |
| Ivette Espinosa-Fernandez | Revival Research Institute | Principal Investigator |
| Annika Smith | Westmead Hospital | Principal Investigator |
| Deirdre Murrell | Premier Specialist | Principal Investigator |
| Lynda Spelman | Veracity Clinical Trials Ltd | Principal Investigator |
| Samantha Eisman |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center | Birmingham | Alabama | 35205 | United States | ||
| Southern California Dermatology, Inc |
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| Drug |
5 capsules BID of KBL697 or Placebo |
|
| Baseline to Week 12 |
| Psoriasis Area and Severity Index (PASI) -75 | Percent of patients who achieved PASI-75 | Baseline to Week 12 |
| Physician's Global Assessment (PGA) | Change from Baseline in PGA score | Baseline to Weeks 4, 8 and 12 |
| Physician's Global Assessment (PGA) | Percent of patients who achieve PGA score of 0 or 1 | Week 12 |
| Psoriasis-Affected Body Surface Area (BSA) | Change from Baseline in Psoriasis-Affected BSA | Baseline to Weeks 4, 8 and 12 |
| Safety measure through incidence of treatment-emergent adverse events (TEAEs) | The number of patients experiencing TEAEs and number of individual TEAEs will be summarized among treatment arms, by system organ class (SOC) and PT. TEAEs will also be summarized among treatment arms, by severity and by relationship to study drug. | Baseline to Week 16 |
| Sinclair Dermatology |
| Principal Investigator |
| Santa Ana |
| California |
| 92701 |
| United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Revival Research Institute | Doral | Florida | 33122 | United States |
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States |
| Louisiana Dermatology Associates - Dermatology | Baton Rouge | Louisiana | 70809 | United States |
| Premier Specialist | Kogarah | New South Wales | 2217 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Veracity Clinical Trials Ltd | Woolloongabba | Queensland | 4102 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |