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NCT07449702RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
240 (estimated)
First submitted
26 Feb 2026
Start date
23 Feb 2026
Primary completion date
31 May 2030
Lead sponsor
Oruka Therapeutics, Inc.
Diseases
Psoriasis
NCT number
NCT07449702
EU CT number
2026-526898-42-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 240
  • From 23 Feb 2026 to the primary completion date, 31 May 2030
  • 42 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
  • 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.

Lab values

  • 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.

Other

  • Participant is pregnant or breastfeeding.

Who the study is looking for

  • Signed informed consent by participants from previous trial choosing to transition into the OLE.
  • Participants who have successfully completed the preceding trial.
  • For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
AjaxCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
EdmontonCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
FrederictonCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
LondonCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
MarkhamCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
PeterboroughCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
QuébecCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
SurreyCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
WaterlooCanadaRecruiting
Thermalsole und Schwefelbad Bentheim GmbH
Coordinator of this site? Confirm its status
Bad BentheimGermanyNot yet recruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyNot yet recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyNot yet recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyNot yet recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainNot yet recruiting
Icr Medical S.L.
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MadridSpainNot yet recruiting
Hospital Universitario La Paz
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MadridSpainNot yet recruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
Bowling GreenUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
CromwellUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
Fountain ValleyUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
FriscoUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
MasonUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Oruka Therapeutics Investigative Site
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NorfolkUnited StatesRecruiting
Oruka Therapeutics Investigative Site
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North Little RockUnited StatesRecruiting
Oruka Therapeutics Investigative Site
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PhoenixUnited StatesRecruiting
Oruka Therapeutics Investigative Site
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PlainfieldUnited StatesRecruiting
Oruka Therapeutics Investigative Site
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PortlandUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
RockvilleUnited StatesRecruiting
Oruka Therapeutics Investigative Site
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Rolling MeadowsUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
San DiegoUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
Santa AnaUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
Santa MonicaUnited StatesRecruiting
Oruka Therapeutics Investigative Site
Coordinator of this site? Confirm its status
WebsterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.