Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Last updated: February 27, 2026
Sponsor: Oruka Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Psoriasis And Psoriatic Disorders

Treatment

Placebo

ORKA-001

Clinical Study ID

NCT07290569
ORKA-001-114
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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:

  4. BSA ≥ 10%, and

  5. PASI ≥ 12, and

  6. IGA score of ≥ 3 on a 5-point scale

  7. Candidate for systemic therapy or phototherapy

  8. Women of childbearing potential must have a negative pregnancy test.

Exclusion

Exclusion Criteria:

  1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) ordrug-induced psoriasis

  2. Significant history or clinical manifestation of any metabolic, otherdermatological, hepatic, renal, hematologic, pulmonary, cardiovascular,gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, orany infectious disease

  3. History of malignancy, except for non-melanoma skin cancer or cancer curativelytreated ≥ 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 Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 03, 2025
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Oruka Therapeutics Investigative Site

    Surrey 6159905, British Columbia 5909050 V3V 0C6
    Canada

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Fredericton 5957776, New Brunswick 6087430 E3B 1G9
    Canada

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Ajax 5882873, Ontario 6093943 L1S 7K8
    Canada

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Peterborough 6101645, Ontario 6093943 K9J 5K2
    Canada

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Montreal 6077243, Quebec 6115047 HZX 2V1
    Canada

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Québec 6325494, Quebec 6115047 G1V 4X7
    Canada

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Phoenix 5308655, Arizona 5551752 85032
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    North Little Rock 4124112, Arkansas 4099753 72117
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Los Angeles 5368361, California 5332921 90045
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Rolling Meadows 4908052, Illinois 4896861 60008
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Plainfield 4263108, Indiana 4921868 46168
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Rockville 4367175, Maryland 4361885 20850
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Kew Gardens 5123344, New York 5128638 11415
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Chapel Hill 4460162, North Carolina 4482348 27516
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Mason 4517698, Ohio 5165418 45040
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Portland 5746545, Oregon 5744337 97210
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Frisco 4692559, Texas 4736286 75033
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Houston 4699066, Texas 4736286 77004
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Webster 4740423, Texas 4736286 77598
    United States

    Active - Recruiting

  • Oruka Therapeutics Investigative Site

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Active - Recruiting

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