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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing ORKA-001 for Plaque Psoriasis

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

Official registry: https://clinicaltrials.gov/study/NCT07449702 · Oruka Therapeutics, Inc. · enrollment listed as 240

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ORKA-001. The registry lists allocation as randomized. An open-label extension (OLE) study to measure the long-term safety and how well it works of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.

They plan to enroll about 240 people at 34 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: ORKA-001

Primary outcome (registry wording): Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Oruka Clinical Trials Information

781-560-0299

clinicaltrials@orukatx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

34 listed

+ 11 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07449702 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07449702?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07449702?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary