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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-001 in adult participants with moderate-to-severe plaque psoriasis.
This is a multicenter, randomized, double-blinded, placebo-controlled, dose ranging study designed to identify the optimal induction dosing regimen of ORKA-001 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-001 compared to placebo and will include 3 maintenance regimens.
The study will consist of 4 periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Induction Period - Arm 1) ORKA-001 | Experimental | Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen. |
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| (Induction Period - Arm 2) ORKA-001 | Experimental | Participants will receive 300 mg ORKA-001 per protocol Induction regimen. |
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| (Induction Period - Arm 3) ORKA-001 | Experimental | Participants will receive 600 mg ORKA-001 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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| (Maintenance Period - Arm 1) ORKA-001 | Experimental | Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response. |
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| (Maintenance Period - Arm 2) ORKA-001 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORKA-001 | Drug | ORKA-001 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 |
| 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 years of age
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 | Phoenix | Arizona | 85032 | United States |
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Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response. |
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| (Maintenance Period - Arm 3) Placebo | Placebo Comparator | Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response. |
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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 | 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 |
| Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100 | 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 100 |
| Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100 | 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 100 |
| Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100 | 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 100 |
| Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100 | 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 100 |
| Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100 | 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 100 |
| Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs) | Incidence of treatment adverse events, treatment adverse events of special interest, and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms | Day 1 through Week 100 |
| Oruka Therapeutics Investigative Site | Recruiting | North Little Rock | Arkansas | 72117 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Los Angeles | California | 90024 | 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 | Miami | Florida | 33126 | 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 | Plainfield | Indiana | 46168 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Rockville | Maryland | 20850 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Kew Gardens | New York | 11415 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Chapel Hill | North Carolina | 27516 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Mason | Ohio | 45040 | 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 | Portland | Oregon | 97210 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Frisco | Texas | 75033 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Houston | Texas | 77004 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Webster | Texas | 77598 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Norfolk | Virginia | 23502 | United States |
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| Oruka Therapeutics Investigative Site | Recruiting | Surrey | British Columbia | V3R 6A7 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Surrey | British Columbia | V3V 0C6 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Fredericton | New Brunswick | E3B 1G9 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Ajax | Ontario | L1S 7K8 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Markham | Ontario | L3P 1X3 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Peterborough | Ontario | K9J 5K2 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Montreal | Quebec | HZX 2V1 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Québec | Quebec | G1V 4X7 | Canada |
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| Oruka Therapeutics Investigative Site | Recruiting | Heidelberg | Baden-Wuerrtemberg | 69120 | Germany |
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| Oruka Therapeutics Investigative Site | Recruiting | Frankfurt am Main | Hesse | 60590 | Germany |
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| Oruka Therapeutics Investigative Site | Recruiting | Bad Bentheim | Lower Saxony | 48455 | Germany |
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| Oruka Therapeutics Investigative Site | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
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| Oruka Therapeutics Investigative Site | Recruiting | Badalona | Barcelona | 08916 | Spain |
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| Oruka Therapeutics Investigative Site | Recruiting | Barcelona | Barcelona | 08041 | Spain |
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| Oruka Therapeutics Investigative Site | Recruiting | Madrid | Madrid | 28002 | Spain |
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| Oruka Therapeutics Investigative Site | Recruiting | Madrid | Madrid | 28046 | Spain |
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