Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07290569

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

Led by Oruka Therapeutics, Inc. · Updated on 2026-03-30

160

Participants Needed

26

Research Sites

156 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-001 in adult participants with moderate-to-severe plaque psoriasis.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants 18 years of age or older
  • Diagnosis of plaque psoriasis for more than 6 months
  • Moderate-to-severe chronic plaque psoriasis defined by:
    • Body surface area (BSA) 10% or more
    • PASI score 12 or higher
    • Investigator's Global Assessment (IGA) score 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...

  • Nonplaque forms of psoriasis such as guttate, erythrodermic, pustular, or drug-induced psoriasis
  • Significant history or clinical signs 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 at least 5 years prior without recurrence
  • Known hypersensitivity to any components of ORKA-001
  • Women who are breastfeeding or planning 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: 26 locations

1

Oruka Therapeutics Investigative Site

Phoenix, Arizona, United States, 85032

Actively Recruiting

2

Oruka Therapeutics Investigative Site

North Little Rock, Arkansas, United States, 72117

Actively Recruiting

3

Oruka Therapeutics Investigative Site

Los Angeles, California, United States, 90024

Actively Recruiting

4

Oruka Therapeutics Investigative Site

Los Angeles, California, United States, 90045

Actively Recruiting

5

Oruka Therapeutics Investigative Site

San Diego, California, United States, 92123

Actively Recruiting

6

Oruka Therapeutics Investigative Site

Coral Gables, Florida, United States, 33134

Actively Recruiting

7

Oruka Therapeutics Investigative Site

Rolling Meadows, Illinois, United States, 60008

Actively Recruiting

8

Oruka Therapeutics Investigative Site

Plainfield, Indiana, United States, 46168

Actively Recruiting

9

Oruka Therapeutics Investigative Site

Rockville, Maryland, United States, 20850

Actively Recruiting

10

Oruka Therapeutics Investigative Site

Kew Gardens, New York, United States, 11415

Actively Recruiting

11

Oruka Therapeutics Investigative Site

Chapel Hill, North Carolina, United States, 27516

Actively Recruiting

12

Oruka Therapeutics Investigative Site

Cleveland, Ohio, United States, 44106

Actively Recruiting

13

Oruka Therapeutics Investigative Site

Mason, Ohio, United States, 45040

Actively Recruiting

14

Oruka Therapeutics Investigative Site

Portland, Oregon, United States, 97201

Actively Recruiting

15

Oruka Therapeutics Investigative Site

Portland, Oregon, United States, 97210

Actively Recruiting

16

Oruka Therapeutics Investigative Site

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

17

Oruka Therapeutics Investigative Site

Frisco, Texas, United States, 75033

Actively Recruiting

18

Oruka Therapeutics Investigative Site

Houston, Texas, United States, 77004

Actively Recruiting

19

Oruka Therapeutics Investigative Site

Webster, Texas, United States, 77598

Actively Recruiting

20

Oruka Therapeutics Investigative Site

Norfolk, Virginia, United States, 23502

Actively Recruiting

21

Oruka Therapeutics Investigative Site

Surrey, British Columbia, Canada, V3V 0C6

Actively Recruiting

22

Oruka Therapeutics Investigative Site

Fredericton, New Brunswick, Canada, E3B 1G9

Actively Recruiting

23

Oruka Therapeutics Investigative Site

Ajax, Ontario, Canada, L1S 7K8

Actively Recruiting

24

Oruka Therapeutics Investigative Site

Peterborough, Ontario, Canada, K9J 5K2

Actively Recruiting

25

Oruka Therapeutics Investigative Site

Montreal, Quebec, Canada, HZX 2V1

Actively Recruiting

26

Oruka Therapeutics Investigative Site

Québec, Quebec, Canada, G1V 4X7

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

7

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