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

May 29, 2026 updated by: Oruka Therapeutics, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Ontario
      • London, Ontario, Canada, N6H 5L5
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Markham, Ontario, Canada, L3P 1X3
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Peterborough, Ontario, Canada, K9J 5K2
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Toronto, Ontario, Canada, M4W 2N4
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Waterloo, Ontario, Canada, N2J 1C4
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Santa Ana, California, United States, 92701
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Illinois
      • Rolling Meadows, Illinois, United States, 60008
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • New York
      • New York, New York, United States, 10023
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97201
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent by participants from previous trial choosing to transition into the OLE.
  2. Participants who have successfully completed the preceding trial.
  3. For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
  4. 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:

  1. 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
  2. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
  3. 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.
  4. 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.
  5. Participant is pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ORKA-001 Twice Yearly
Participants will receive ORKA-001 every 6 months per OLE protocol.
Drug: ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
No Intervention: No Drug
Participants will receive no drug until protocol defined PASI response criterion is met.
Experimental: ORKA-001 Once Yearly (High Dose)
Participants will receive ORKA-001 once a year per OLE protocol.
Drug: ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Experimental: ORKA-001 Once Yearly (Low Dose)
Participants will receive ORKA-001 once a year per OLE protocol.
Drug: ORKA-001
ORKA-001 administered by subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 through Week 144

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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
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).
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
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
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).
Day 1 through Week 96
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).
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
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
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).
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oruka Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORKA-001-113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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