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This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.
This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 in approximately 160 adult participants with moderate-to-severe plaque psoriasis.
The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo.
The study will consist of 3 periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Induction Period - Arm 1) ORKA-002 | Experimental | Participants will receive ORKA-002 per protocol Induction regimen. |
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| (Induction Period - Arm 2) ORKA-002 | Experimental | Participants will receive ORKA-002 per protocol Induction regimen. |
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| (Induction Period - Arm 3) ORKA-002 | Experimental | Participants will receive ORKA-002 per protocol Induction regimen. |
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| (Induction Period - Arm 4) Placebo | Placebo Comparator | Participants will receive Placebo per protocol Induction regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORKA-002 | Drug | ORKA-002 administered by subcutaneous (SC) injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 | The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease). | Week 16 |
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs) | Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms | Day 1 through Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16 | The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). | Week 16 |
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Inclusion Criteria:
Participants ≥ 18 and < 80 years of age at the time of consent
Have a diagnosis of plaque psoriasis for > 6 months
Have moderate-to-severe chronic plaque psoriasis defined as:
Candidate for systemic therapy or phototherapy
Women of childbearing potential must have a negative pregnancy test
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oruka Clinical Trials Information | Contact | 781-560-0299 | clinicaltrials@orukatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oruka Therapeutics Investigative Site | Recruiting | Birmingham | Alabama | 35203 | United States |
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| Placebo | Other | Placebo administered by subcutaneous (SC) injection |
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| Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16 | Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease). | Week 16 |
| Proportion of Participants Who Achieve an IGA=0 (Clear) or 1 (Almost Clear) at Week 16 | Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease). | Week 16 |
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of Special Interest (TEAESIs) | Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms | Day 1 through Week 48 |
| Oruka Therapeutics Investigative Site | Recruiting | Fountain Valley | California | 92708 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Los Angeles | California | 90045 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | San Diego | California | 92123 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Santa Ana | California | 92701 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Santa Monica | California | 90403 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Cromwell | Connecticut | 06416 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Miami | Florida | 33124 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Rolling Meadows | Illinois | 60008 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Milford | Massachusetts | 01757 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Detroit | Michigan | 48202 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Warren | Michigan | 48088 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | New Brighton | Minnesota | 55112 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Omaha | Nebraska | 68144 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Elmhurst | New York | 11373 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | New York | New York | 10029 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Wilmington | North Carolina | 28405 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Bexley | Ohio | 43209 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Portland | Oregon | 97201 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Warrenton | Oregon | 97146 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Dallas | Texas | 75231 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Dallas | Texas | 75390 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Mill Creek | Washington | 98012 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Edmonton | Alberta | T5J 3S9 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Edmonton | Alberta | T6G 1C3 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Surrey | British Columbia | V3R 6A7 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Barrie | Ontario | L4M 7G1 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | London | Ontario | N6H 5L5 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | North Bay | Ontario | P1B 3Z7 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Peterborough | Ontario | K9J 5K2 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Toronto | Ontario | SK S7K 2C1 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Waterloo | Ontario | N2J 1C4 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Saskatoon | Saskatchewan | S7K 2C1 | Canada |
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