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This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
This is a proof-of-concept study evaluating ORKA-001 in patients with moderate-to-severe psoriasis with study drug administration divided into an Induction period followed by a Maintenance period. Following completion of the Maintenance period at Week 52, participants will have the option to enter into the open-label extension (OLE) study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Induction Period) ORKA-001 | Experimental | Participants will receive ORKA-001 per protocol Induction regimen. |
|
| (Induction Period) Placebo | Placebo Comparator | Participants will receive Placebo per protocol Induction regimen. |
|
| (Maintenance Period - Arm 1) ORKA-001 | Experimental | Participants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response. |
|
| (Maintenance Period - Arm 2) ORKA-001 | Experimental | Participants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response. |
|
| (Maintenance Period - Arm 3) Placebo | Placebo Comparator | Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORKA-001 Induction Dose | Drug | ORKA-001 Induction Dose, administered by subcutaneous (SC) injection |
|
| 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oruka Therapeutics Investigative Site | Fountain Valley | California | 92708 | United States | ||
| Oruka Therapeutics Investigative Site |
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| Placebo | Other | Placebo administered by subcutaneous (SC) injection |
|
| ORKA-001 Maintenance Dose | Drug | ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection |
|
| 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 52 | 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 52 |
| Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 52 | 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 52 |
| Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 52 | 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 52 |
| Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 52 | 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 52 |
| Incidence of Treatment-emergent Adverse Events | Incidence of treatment adverse events and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms | Day 1 through 52 Weeks |
| Los Angeles |
| California |
| 90045 |
| United States |
| Oruka Therapeutics Investigative Site | San Diego | California | 92123 | United States |
| Oruka Therapeutics Investigative Site | Santa Ana | California | 92701 | United States |
| Oruka Therapeutics Investigative Site | Santa Monica | California | 90403 | United States |
| Oruka Therapeutics Investigative Site | Cromwell | Connecticut | 06416 | United States |
| Oruka Therapeutics Investigative Site | Miami | Florida | 33126 | United States |
| Oruka Therapeutics Investigative Site | Rolling Meadows | Illinois | 60008 | United States |
| Oruka Therapeutics Investigative Site | Bowling Green | Kentucky | 42104 | United States |
| Oruka Therapeutics Investigative Site | Rockville | Maryland | 20850 | United States |
| Oruka Therapeutics Investigative Site | Boston | Massachusetts | 02111 | United States |
| Oruka Therapeutics Investigative Site | Detroit | Michigan | 48202 | United States |
| Oruka Therapeutics Investigative Site | New York | New York | 10023 | United States |
| Oruka Therapeutics Investigative Site | New York | New York | 10029 | United States |
| Oruka Therapeutics Investigative Site | Portland | Oregon | 97201 | United States |
| Oruka Therapeutics Investigative Site | Norfolk | Virginia | 23502 | United States |
| Oruka Therapeutics Investigative Site | Milwaukee | Wisconsin | 53226 | United States |
| Oruka Therapeutics Investigative Site | Edmonton | Alberta | T5J 3S9 | Canada |
| Oruka Therapeutics Investigative Site | Edmonton | Alberta | T6G 1C3 | Canada |
| Oruka Therapeutics Investigative Site | Surrey | British Columbia | V3R 6A7 | Canada |
| Oruka Therapeutics Investigative Site | Hamilton | Ontario | L8N 1Y2 | Canada |
| Oruka Therapeutics Investigative Site | London | Ontario | N6H 5LS | Canada |
| Oruka Therapeutics Investigative Site | Markham | Ontario | L3P 1X3 | Canada |
| Oruka Therapeutics Investigative Site | Peterborough | Ontario | K9J 5K2 | Canada |
| Oruka Therapeutics Investigative Site | Toronto | Ontario | M4W 2N4 | Canada |
| Oruka Therapeutics Investigative Site | Waterloo | Ontario | N2J 1C4 | Canada |