Recruiting NCT07449702
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ORKA-001.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- Drug ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Primary outcome measures
- Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs) [Time frame: Day 1 through Week 144]
Secondary outcome measures (9)
- Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE [Time frame: Day 1 through Week 96]
- Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Day 1 through Week 96]
- Time-to-loss of PASI100 in the Subset of Participants who achieved PASI100 at Baseline of OLE [Time frame: Day 1 through Week 96]
- Time-to-loss of PASI90 in the Subset of Participants who achieved PASI90 at Baseline of the OLE [Time frame: Day 1 through Week 96]
- PASI Score Over Time [Time frame: Day 1 through Week 96]
- IGA Score Over Time [Time frame: Day 1 through Week 96]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- Oruka Therapeutics Investigative Site — Fountain Valley
- Oruka Therapeutics Investigative Site — Los Angeles
- Oruka Therapeutics Investigative Site — San Diego
- Oruka Therapeutics Investigative Site — Santa Ana
- Oruka Therapeutics Investigative Site — Santa Monica
- Oruka Therapeutics Investigative Site — Cromwell
- Oruka Therapeutics Investigative Site — Miami
- Oruka Therapeutics Investigative Site — Rolling Meadows
- … and 10 more centers
Canada · 8 centers
- Oruka Therapeutics Investigative Site — Edmonton
- Oruka Therapeutics Investigative Site — Edmonton
- Oruka Therapeutics Investigative Site — Surrey
- Oruka Therapeutics Investigative Site — London
- Oruka Therapeutics Investigative Site — Markham
- Oruka Therapeutics Investigative Site — Peterborough
- Oruka Therapeutics Investigative Site — Toronto
- Oruka Therapeutics Investigative Site — Waterloo
Identifiers
NCT: NCT07449702 · ORKA-001-113