Plaque PsoriasisPhase 2NCT07449702
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
A Phase 2 study testing ORKA-001 in people with Plaque Psoriasis, run by Oruka Therapeutics, Inc. at 39 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- ORKA-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 23 Feb 2026to Jul 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent by participants from previous trial choosing to transition into the OLE.
- Participants who have successfully completed the preceding trial.
- For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
- For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception
Who cannot join
- Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001
- Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
- Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.
- Participant is pregnant or breastfeeding.
Trial locations and contacts
39 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 2 countries
United States26 sites, 26 recruiting
- Recruiting
Oruka Therapeutics Investigative Site
Boston, Massachusetts, 02111
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Bowling Green, Kentucky, 42104
Oruka Investigative Site, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Cleveland, Ohio, 44106
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Cromwell, Connecticut, 06416
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Detroit, Michigan, 48202
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Fountain Valley, California, 92708
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Frisco, Texas, 75033
Oruka Therapeutics Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Houston, Texas, 77004
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Los Angeles, California, 90045
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Los Angeles, California, 90095
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Mason, Ohio, 45040
Oruka Therapeutics Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Miami, Florida, 33126
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
New York, New York, 10023
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
New York, New York, 10029
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Norfolk, Virginia, 23502
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
North Little Rock, Arkansas, 72117
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Phoenix, Arizona, 85032
Oruka Therapeutics Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Plainfield, Indiana, 46168
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Portland, Oregon, 97201
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Portland, Oregon, 97210
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Rockville, Maryland, 20850
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Rolling Meadows, Illinois, 60008
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
San Diego, California, 92123
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Santa Ana, California, 92701
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Santa Monica, California, 90403
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Webster, Texas, 77598
Oruka Therapeutics Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
Canada13 sites, 13 recruiting
- Recruiting
Oruka Therapeutics Investigative Site
Ajax, Ontario, L1S7K8
Oruka Therapeutics Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Edmonton, Alberta, T5J 3S9
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Edmonton, Alberta, T6G 1C3
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Fredericton, New Brunswick, E3B IG9
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
London, Ontario, N6H 5L5
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Markham, Ontario, L3P 1X3
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Montreal, Quebec, H2X2V1
Oruka Therapeutics Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Peterborough, Ontario, K9J 5K2
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Québec, Quebec, G1V4X7
Oruka Therapeutics Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Surrey, British Columbia, V3R 6A7
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Surrey, British Columbia, V3V 0C6
Oruka Therapeutics Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Toronto, Ontario, M4W 2N4
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Waterloo, Ontario, N2J 1C4
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
About this study
Official title: An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
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.
Read the detailed description
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.
- Conditions
- Plaque Psoriasis
- Being tested
- ORKA-001
- Keywords
- Phase 2, ORKA-001, Open Label Extension, OLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORKA-001Drug
ORKA-001 administered by subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| ORKA-001 Once Yearly (High Dose) | Experimental | Participants will receive ORKA-001 once a year per OLE protocol. Receives: Drug: ORKA-001 |
| ORKA-001 Once Yearly (Low Dose) | Experimental | Participants will receive ORKA-001 once a year per OLE protocol. Receives: Drug: ORKA-001 |
| ORKA-001 Twice Yearly | Experimental | Participants will receive ORKA-001 every 6 months per OLE protocol. Receives: Drug: ORKA-001 |
| No Drug | No intervention | Participants will receive no drug until protocol defined PASI response criterion is met. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 through Week 144
Secondary outcomes (9)
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).
Measured: Day 1 through Week 96
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 1 through Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start23 Feb 2026
- Primary completionMay 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oruka Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449702
- Sponsor's protocol ID
- ORKA-001-113
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided