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NCT07449702PHASE2Recruiting

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Oruka Therapeutics, Inc.

Start Date

2/23/2026

Completion Date

7/1/2030

Summary

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.

Detailed Description

This open-label extension study evaluates the long-term safety and efficacy of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label treatment period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last study visit.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Signed informed consent by participants from previous trial choosing to transition into the OLE. 2. Participants who have successfully completed the preceding trial. 3. For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit. 4. For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception Exclusion Criteria: 1. Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001 2. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial. 3. Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data. 4. Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001. 5. Participant is pregnant or breastfeeding.

Interventions

DRUG

ORKA-001

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Conditions

Plaque Psoriasis

Locations

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 33126

United States

Oruka Therapeutics Investigative Site

Rolling Meadows, Illinois 60008

United States

Oruka Therapeutics Investigative Site

Bowling Green, Kentucky 42104

United States

Oruka Therapeutics Investigative Site

Rockville, Maryland 20850

United States

Oruka Therapeutics Investigative Site

Boston, Massachusetts 02111

United States

Oruka Therapeutics Investigative Site

Detroit, Michigan 48202

United States

Oruka Therapeutics Investigative Site

New York, New York 10023

United States

Oruka Therapeutics Investigative Site

New York, New York 10029

United States

Oruka Therapeutics Investigative Site

Portland, Oregon 97201

United States

Oruka Therapeutics Investigative Site

Norfolk, Virginia 23502

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

London, Ontario N6H 5L5

Canada

Oruka Therapeutics Investigative Site

Markham, Ontario L3P 1X3

Canada

Oruka Therapeutics Investigative Site

Peterborough, Ontario K9J 5K2

Canada

Oruka Therapeutics Investigative Site

Toronto, Ontario M4W 2N4

Canada

Oruka Therapeutics Investigative Site

Waterloo, Ontario N2J 1C4

Canada