Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.
This open-label extension study evaluates the long-term safety and efficacy of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label treatment period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last study visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORKA-001 Once Yearly (High Dose) | Experimental | Participants will receive ORKA-001 once a year per OLE protocol. |
|
| ORKA-001 Once Yearly (Low Dose) | Experimental | Participants will receive ORKA-001 once a year per OLE protocol. |
|
| ORKA-001 Twice Yearly | Experimental | Participants will receive ORKA-001 every 6 months per OLE protocol. |
|
| No Drug | No Intervention | Participants will receive no drug until protocol defined PASI response criterion is met. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORKA-001 | Drug | ORKA-001 administered by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs) | Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms. | Day 1 through Week 144 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE | 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). | Day 1 through Week 96 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oruka Clinical Trials Information | Contact | 781-560-0299 | clinicaltrials@orukatx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oruka Therapeutics Investigative Site | Recruiting | Fountain Valley | California | 92708 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE | 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). | Day 1 through Week 96 |
| Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0 in the Subset of Participants Meeting the Criterion at Baseline of OLE | 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). | Day 1 through Week 96 |
| Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0/1 in the Subset of Participants Meeting the Criterion at Baseline of OLE | 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). | Time Frame: Day 1 through Week 96 |
| Proportion of Participants with an Improvement of their OLE Baseline PASI Score in the Subset of Participants who did not Achieve PASI75 at OLE Baseline | 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). | Day 1 through Week 96 |
| Time-to-loss of PASI100 in the Subset of Participants who achieved PASI100 at Baseline of OLE | 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). | Day 1 through Week 96 |
| Time-to-loss of PASI90 in the Subset of Participants who achieved PASI90 at Baseline of the OLE | 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). | Day 1 through Week 96 |
| PASI Score Over Time | 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). | Day 1 through Week 96 |
| IGA Score Over Time | 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). | Day 1 through Week 96 |
| Oruka Therapeutics Investigative Site | Recruiting | Los Angeles | California | 90045 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | San Diego | California | 92123 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Santa Ana | California | 92701 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Santa Monica | California | 90403 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Cromwell | Connecticut | 06416 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Miami | Florida | 33126 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Rolling Meadows | Illinois | 60008 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Bowling Green | Kentucky | 42104 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Rockville | Maryland | 20850 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Boston | Massachusetts | 02111 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | New York | New York | 10023 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | New York | New York | 10029 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Portland | Oregon | 97201 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Norfolk | Virginia | 23502 | United States |
|
| Oruka Therapeutics Investigative Site | Recruiting | Edmonton | Alberta | T5J 3S9 | Canada |
|
| Oruka Therapeutics Investigative Site | Recruiting | Edmonton | Alberta | T6G 1C3 | Canada |
|
| Oruka Therapeutics Investigative Site | Recruiting | Surrey | British Columbia | V3R 6A7 | Canada |
|
| Oruka Therapeutics Investigative Site | Recruiting | London | Ontario | N6H 5L5 | Canada |
|
| Oruka Therapeutics Investigative Site | Recruiting | Markham | Ontario | L3P 1X3 | Canada |
|
| Oruka Therapeutics Investigative Site | Recruiting | Peterborough | Ontario | K9J 5K2 | Canada |
|
| Oruka Therapeutics Investigative Site | Recruiting | Toronto | Ontario | M4W 2N4 | Canada |
|
| Oruka Therapeutics Investigative Site | Recruiting | Waterloo | Ontario | N2J 1C4 | Canada |
|