ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.

Key facts

Study ID

NCT07090330

Run by

Oruka Therapeutics, Inc.

People needed

80

Starts

2025-07-18

Expected to finish

2027-05-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants ≥ 18 years of age
• Have a diagnosis of plaque psoriasis for > 6 months
• Have moderate-to-severe chronic plaque psoriasis defined as:
• BSA ≥ 10%, and
• PASI ≥ 12, and
• IGA score of ≥ 3 on a 5-point scale
• Candidate for systemic therapy or phototherapy
• Women of childbearing potential must have a negative pregnancy test

You may not qualify if…

• Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
• 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
• History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
• A known hypersensitivity to any components of the ORKA-001 drug product
• Women who are breastfeeding or plan to breastfeed during the study

Where it is running

• Oruka Therapeutics Investigative Site — Fountain Valley, California, United States
• Oruka Therapeutics Investigative Site — Los Angeles, California, United States
• Oruka Therapeutics Investigative Site — San Diego, California, United States
• Oruka Therapeutics Investigative Site — Santa Ana, California, United States
• Oruka Therapeutics Investigative Site — Santa Monica, California, United States
• Oruka Therapeutics Investigative Site — Cromwell, Connecticut, United States
• Oruka Therapeutics Investigative Site — Miami, Florida, United States
• Oruka Therapeutics Investigative Site — Rolling Meadows, Illinois, United States
• Oruka Therapeutics Investigative Site — Bowling Green, Kentucky, United States
• Oruka Therapeutics Investigative Site — Rockville, Maryland, United States
• Oruka Therapeutics Investigative Site — Boston, Massachusetts, United States
• Oruka Therapeutics Investigative Site — Detroit, Michigan, United States
• Oruka Therapeutics Investigative Site — New York, New York, United States
• Oruka Therapeutics Investigative Site — New York, New York, United States
• Oruka Therapeutics Investigative Site — Portland, Oregon, United States
• Oruka Therapeutics Investigative Site — Norfolk, Virginia, United States
• Oruka Therapeutics Investigative Site — Milwaukee, Wisconsin, United States
• Oruka Therapeutics Investigative Site — Edmonton, Alberta, Canada
• Oruka Therapeutics Investigative Site — Edmonton, Alberta, Canada
• Oruka Therapeutics Investigative Site — Surrey, British Columbia, Canada
• Oruka Therapeutics Investigative Site — Hamilton, Ontario, Canada
• Oruka Therapeutics Investigative Site — London, Ontario, Canada
• Oruka Therapeutics Investigative Site — Markham, Ontario, Canada
• Oruka Therapeutics Investigative Site — Peterborough, Ontario, Canada
• Oruka Therapeutics Investigative Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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