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NCT Number: NCT07449702

An Open-Label Extension Study of ORKA-001 in Participants With 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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oruka Therapeutics Investigative Site, Edmonton, Alberta, Canada

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ORKA-001

Drug

ORKA-001 administered by subcutaneous (SC) injection

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE

    Time frame: Day 1 through Week 96

    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).

  2. Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE

    Time frame: Day 1 through Week 96

    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).

  3. 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

    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).

  4. 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

    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).

  5. 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

    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).

  6. Time-to-loss of PASI100 in the Subset of Participants who achieved PASI100 at Baseline of OLE

    Time frame: Day 1 through Week 96

    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).

  7. 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

    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).

  8. PASI Score Over Time

    Time frame: Day 1 through Week 96

    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).

  9. IGA Score Over Time

    Time frame: Day 1 through Week 96

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Oruka Clinical Trials Information

CONTACT

[email protected]

781-560-0299

Sponsors and collaborators

Lead sponsor

Oruka Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 4, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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