Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis (EVERLAST-B)

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

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, double-blinded, placebo-controlled, dose ranging study designed to identify the optimal induction dosing regimen of ORKA-001 in approximately 160 adult participants with moderate-to-severe plaque psoriasis.

The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-001 compared to placebo and will include 3 maintenance regimens.

The study will consist of 4 periods:

  • Screening Period of up to 6 weeks
  • Induction Period of up to 28 weeks (Day 1 [Baseline] to Week 28)
  • Maintenance Period of up to approximately 72 weeks (Week 28 to Week 100)
  • Post-treatment Follow-up Period: Participants will have the option to enter the open-label extension (OLE) study. Participants who opt out of the OLE study and/or withdraw from the study must be followed for 48 weeks after the End of Treatment (EOT)/Early Termination (ET) visit.

Study Type

Interventional

Enrollment (Estimated)

160

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:
      • Surrey, British Columbia, Canada, V3V 0C6
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • 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:
    • Quebec
      • Montreal, Quebec, Canada, HZX 2V1
      • Québec, Quebec, Canada, G1V 4X7
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
  • Germany
    • Baden-Wuerrtemberg
      • Heidelberg, Baden-Wuerrtemberg, Germany, 69120
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Barcelona, Barcelona, Spain, 08041
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Madrid
      • Madrid, Madrid, Spain, 28002
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Madrid, Madrid, Spain, 28046
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • California
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Los Angeles, California, United States, 90024
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • San Diego, California, United States, 92123
        • 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:
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • New York
      • Kew Gardens, New York, United States, 11415
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Mason, Ohio, United States, 45040
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97201
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Texas
      • Frisco, Texas, United States, 75033
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Houston, Texas, United States, 77004
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Webster, Texas, United States, 77598
        • 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. Participants ≥ 18 years of age
  2. Have a diagnosis of plaque psoriasis for > 6 months

  3. Have moderate-to-severe chronic plaque psoriasis defined as:

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

Exclusion Criteria:

  1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
  2. 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
  3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
  4. A known hypersensitivity to any components of the ORKA-001 drug product
  5. Women who are breastfeeding or plan to breastfeed during the study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: (Maintenance Period - Arm 3) Placebo
Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.
Other: Placebo
Placebo administered by subcutaneous (SC) injection
Experimental: (Induction Period - Arm 1) ORKA-001
Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.
Drug: ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Experimental: (Induction Period - Arm 2) ORKA-001
Participants will receive 300 mg ORKA-001 per protocol Induction regimen.
Drug: ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Experimental: (Induction Period - Arm 3) ORKA-001
Participants will receive 600 mg ORKA-001 per protocol Induction regimen.
Drug: ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Placebo Comparator: (Induction Period - Arm 4) Placebo
Participants will receive Placebo per protocol Induction regimen.
Other: Placebo
Placebo administered by subcutaneous (SC) injection
Experimental: (Maintenance Period - Arm 1) ORKA-001
Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
Drug: ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Experimental: (Maintenance Period - Arm 2) ORKA-001
Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
Drug: ORKA-001
ORKA-001 administered by subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 16
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).
Week 16
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).
Week 16
Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100
Time Frame: Week 100
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).
Week 100
Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100
Time Frame: Week 100
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).
Week 100
Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100
Time Frame: Week 100
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).
Week 100
Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100
Time Frame: Week 100
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).
Week 100
Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100
Time Frame: Week 100
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).
Week 100
Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs)
Time Frame: Day 1 through Week 100
Incidence of treatment adverse events, treatment adverse events of special interest, and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Day 1 through Week 100

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)

December 3, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 18, 2025

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-001-114

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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