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An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

NCT07449702•Oruka Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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, 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.

Locations (6)

Oruka Therapeutics Investigative Site

Los Angeles, California, United States

Oruka Therapeutics Investigative Site

San Diego, California, United States

Oruka Therapeutics Investigative Site

Coral Gables, Florida, United States

Oruka Therapeutics Investigative Site

Bowling Green, Kentucky, United States

Oruka Therapeutics Investigative Site

Rockville, Maryland, United States

Oruka Therapeutics Investigative Site

Peterborough, Ontario, Canada

Key Dates

Start Date

February 23, 2026

Primary Completion Date

November 1, 2028

Completion Date

January 1, 2029

Last Updated

March 6, 2026

Enrollment

80

ESTIMATED participants

Conditions

Plaque Psoriasis

Interventions

ORKA-001

DRUG

Contacts

Oruka Clinical Trials Information

CONTACT

781-560-0299 clinicaltrials@orukatx.com

Sponsors

Lead Sponsor

Oruka Therapeutics, Inc.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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