Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis

May 22, 2026 updated by: Oruka Therapeutics, Inc.

A Multicenter, Randomized, Double-Blinded, Placebo- Controlled, Dose-Range Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 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-002 in adult participants with moderate-to-severe plaque psoriasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 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-002 compared to placebo.

The study will consist of 3 periods:

  • Screening Period
  • Induction Period
  • Post-treatment Follow-up Period

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3S9
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • London, Ontario, Canada, N6H 5L5
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • North Bay, Ontario, Canada, P1B 3Z7
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Peterborough, Ontario, Canada, K9J 5K2
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Toronto, Ontario, Canada, SK S7K 2C1
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Waterloo, Ontario, Canada, N2J 1C4
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 2C1
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35203
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • 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:
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Warren, Michigan, United States, 48088
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • North Carolina
      • Wilmington, North Carolina, United States, 28405
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97201
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Warrenton, Oregon, United States, 97146
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Oruka Therapeutics Investigative Site
        • Contact:
    • Washington
      • Mill Creek, Washington, United States, 98012
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants ≥ 18 and < 80 years of age at the time of consent
  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-002 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: (Induction Period - Arm 4) Placebo
Participants will receive Placebo per protocol Induction regimen.
Other: Placebo
Placebo administered by subcutaneous (SC) injection
Experimental: (Induction Period - Arm 1) ORKA-002
Participants will receive ORKA-002 per protocol Induction regimen.
Drug: ORKA-002
ORKA-002 administered by subcutaneous (SC) injection
Experimental: (Induction Period - Arm 2) ORKA-002
Participants will receive ORKA-002 per protocol Induction regimen.
Drug: ORKA-002
ORKA-002 administered by subcutaneous (SC) injection
Experimental: (Induction Period - Arm 3) ORKA-002
Participants will receive ORKA-002 per protocol Induction regimen.
Drug: ORKA-002
ORKA-002 administered by subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs)
Time Frame: Day 1 through Week 48
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Day 1 through Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of Special Interest (TEAESIs)
Time Frame: Day 1 through Week 48
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Day 1 through Week 48

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORKA-002-212

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.

Clinical Trials on Plaque Psoriasis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings