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NCT Number: NCT07090330

ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

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.

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This study is active but is not currently recruiting participants.

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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 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.

Who can participate

Healthy volunteers accepted: No

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

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:
  • BSA ≥ 10%, and
  • PASI ≥ 12, and
  • IGA score of ≥ 3 on a 5-point scale
  • Candidate for systemic therapy or phototherapy
  • Women of childbearing potential must have a negative pregnancy test

Exclusion criteria

  • Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
  • Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease
  • History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
  • A known hypersensitivity to any components of the ORKA-001 drug product
  • Women who are breastfeeding or plan to breastfeed during the study

Treatment and study plan

ORKA-001 Induction Dose

Drug

ORKA-001 Induction Dose, administered by subcutaneous (SC) injection

Placebo

Other

Placebo administered by subcutaneous (SC) injection

ORKA-001 Maintenance Dose

Drug

ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection

Primary outcomes

  1. Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16

    Time frame: 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).

Secondary outcomes

  1. Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16

    Time frame: 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).

  2. Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16

    Time frame: 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).

  3. Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16

    Time frame: 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).

  4. Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 52

    Time frame: 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).

  5. Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 52

    Time frame: 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).

  6. Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 52

    Time frame: 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).

  7. Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 52

    Time frame: 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).

  8. Incidence of Treatment-emergent Adverse Events

    Time frame: Day 1 through 52 Weeks

    Incidence of treatment adverse events and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms

Sponsors and collaborators

Lead sponsor

Oruka Therapeutics, Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

Acronym: EVERLAST-A

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 29, 2025
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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