Actively Recruiting

Phase 2
Age: 18Years - 79Years
All Genders
NCT07474792

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

Led by Oruka Therapeutics, Inc. · Updated on 2026-04-22

160

Participants Needed

27

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 to less than 80 years
  • Diagnosis of plaque psoriasis for more than 6 months
  • Moderate-to-severe chronic plaque psoriasis defined by Body Surface Area (BSA) of at least 10%, Psoriasis Area and Severity Index (PASI) score of at least 12, and Investigator Global Assessment (IGA) score of 3 or higher on a 5-point scale
  • Candidate for systemic therapy or phototherapy
  • Women of childbearing potential must have a negative pregnancy test
Not Eligible

You will not qualify if you...

  • Presence of nonplaque forms of psoriasis such as guttate, erythrodermic, pustular, or drug-induced psoriasis
  • Significant history or clinical manifestations of metabolic, dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, psychiatric disorders, or infectious diseases
  • History of malignancy except non-melanoma skin cancer or cancer treated curatively with no recurrence for at least 5 years
  • Known hypersensitivity to any components of the ORKA-002 drug product
  • Women who are breastfeeding or plan to breastfeed during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology

Birmingham, Alabama, United States, 35203

Actively Recruiting

2

First OC Dermatology Research, Inc.

Fountain Valley, California, United States, 92708

Actively Recruiting

3

TCR Medical Corporation

San Diego, California, United States, 92123

Actively Recruiting

4

Southern California Clinical Research

Santa Ana, California, United States, 92701

Actively Recruiting

5

Institute of Clinical Research and Consulting, Inc., d/b/a Clinical Science Institute

Santa Monica, California, United States, 90404

Actively Recruiting

6

Central Connecticut Dermatology Research, PLLC

Cromwell, Connecticut, United States, 06416

Actively Recruiting

7

Driven Research LLC

Coral Gables, Florida, United States, 33134

Actively Recruiting

8

Kuchnir Dermatology & Dermatologic Surgery

Milford, Massachusetts, United States, 01757

Actively Recruiting

9

Henry Ford Medical Center

Detroit, Michigan, United States, 48202

Actively Recruiting

10

Grekin Skin Institute

Warren, Michigan, United States, 48088

Actively Recruiting

11

Associated Skin Care Specialists, PA d/b/a Minnesota Clinical Study Center

New Brighton, Minnesota, United States, 55112

Actively Recruiting

12

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska, United States, 68144

Actively Recruiting

13

Icahn School of Medicine at Mount Sinai, Department of Dermatology

New York, New York, United States, 10029

Actively Recruiting

14

WDC Cosmetic and Research, PLLC

Wilmington, North Carolina, United States, 28405

Actively Recruiting

15

Bexley Dermatology Research

Bexley, Ohio, United States, 43209

Actively Recruiting

16

Clear Choice Dermatology LLC

Warrenton, Oregon, United States, 97146

Actively Recruiting

17

Modern Research Associates, PLLC

Dallas, Texas, United States, 75231

Actively Recruiting

18

Frontier Derm Partners CRO LLC

Mill Creek, Washington, United States, 98012

Actively Recruiting

19

Alberta DermaSurgery Centre

Edmonton, Alberta, Canada, AB T6G 1C3

Actively Recruiting

20

Laser Rejuvenation Clinics Edmonton D.T. Inc.

Edmonton, Alberta, Canada, T5J 3S9

Actively Recruiting

21

Dr. Chih-ho Hong Medical Inc

Surrey, British Columbia, Canada, V3R 6A7

Actively Recruiting

22

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, Canada, L4M 7G1

Actively Recruiting

23

DermEffects

London, Ontario, Canada, N6H 5L5

Actively Recruiting

24

North Bay Dermatology Centre Inc.

North Bay, Ontario, Canada, P1B 3Z7

Actively Recruiting

25

SKiN Centre for Dermatology

Peterborough, Ontario, Canada, K9J 5K2

Actively Recruiting

26

Toronto Research Centre Inc.

Toronto, Ontario, Canada, SK S7K 2C1

Actively Recruiting

27

Alliance Clinical Trials Inc.

Waterloo, Ontario, Canada, N2J 1C4

Actively Recruiting

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Research Team

O

Oruka Clinical Trials Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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