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NCT07474792PHASE2Recruiting

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

Oruka Therapeutics, Inc.

Start Date

3/19/2026

Completion Date

4/1/2029

Summary

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.

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

Eligibility Criteria

Age Range: 18 years to 79 years

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

Interventions

DRUG

ORKA-002

OTHER

Placebo

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Conditions

Plaque Psoriasis

Locations

Oruka Therapeutics Investigative Site

Birmingham, Alabama 35203

United States

Oruka Therapeutics Investigative Site

Fountain Valley, California 92708

United States

Oruka Therapeutics Investigative Site

Los Angeles, California 90045

United States

Oruka Therapeutics Investigative Site

San Diego, California 92123

United States

Oruka Therapeutics Investigative Site

Santa Ana, California 92701

United States

Oruka Therapeutics Investigative Site

Santa Monica, California 90403

United States

Oruka Therapeutics Investigative Site

Cromwell, Connecticut 06416

United States

Oruka Therapeutics Investigative Site

Miami, Florida 33124

United States

Oruka Therapeutics Investigative Site

Rolling Meadows, Illinois 60008

United States

Oruka Therapeutics Investigative Site

Milford, Massachusetts 01757

United States

Oruka Therapeutics Investigative Site

Ann Arbor, Michigan 48109

United States

Oruka Therapeutics Investigative Site

Detroit, Michigan 48202

United States

Oruka Therapeutics Investigative Site

Warren, Michigan 48088

United States

Oruka Therapeutics Investigative Site

New Brighton, Minnesota 55112

United States

Oruka Therapeutics Investigative Site

Omaha, Nebraska 68144

United States

Oruka Therapeutics Investigative Site

Elmhurst, New York 11373

United States

Oruka Therapeutics Investigative Site

New York, New York 10029

United States

Oruka Therapeutics Investigative Site

Wilmington, North Carolina 28405

United States

Oruka Therapeutics Investigative Site

Bexley, Ohio 43209

United States

Oruka Therapeutics Investigative Site

Portland, Oregon 97201

United States

Oruka Therapeutics Investigative Site

Warrenton, Oregon 97146

United States

Oruka Therapeutics Investigative Site

Dallas, Texas 75231

United States

Oruka Therapeutics Investigative Site

Dallas, Texas 75390

United States

Oruka Therapeutics Investigative Site

Mill Creek, Washington 98012

United States

Oruka Therapeutics Investigative Site

Edmonton, Alberta T5J 3S9

Canada

Oruka Therapeutics Investigative Site

Edmonton, Alberta T6G 1C3

Canada

Oruka Therapeutics Investigative Site

Surrey, British Columbia V3R 6A7

Canada

Oruka Therapeutics Investigative Site

Barrie, Ontario L4M 7G1

Canada

Oruka Therapeutics Investigative Site

London, Ontario N6H 5L5

Canada

Oruka Therapeutics Investigative Site

North Bay, Ontario P1B 3Z7

Canada

Oruka Therapeutics Investigative Site

Peterborough, Ontario K9J 5K2

Canada

Oruka Therapeutics Investigative Site

Toronto, Ontario SK S7K 2C1

Canada

Oruka Therapeutics Investigative Site

Waterloo, Ontario N2J 1C4

Canada

Oruka Therapeutics Investigative Site

Saskatoon, Saskatchewan S7K 2C1

Canada