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Clinical Trials/2026-526898-42-00
2026-526898-42-00RecruitingPhase 2

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

Oruka Therapeutics Inc.8 sites in 2 countries30 target enrollmentStarted: December 1, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
30
Locations
8
Primary Endpoint
Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To evaluate the long-term safety of the maintenance regimens of ORKA-001 in participants with moderate-to-severe plaque psoriasis

Study Design

Allocation
Na
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.
  • •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
  • •Participant is pregnant or breastfeeding

Arms & Interventions

ORKA-001

Test

Intervention: ORKA-001 (Drug)

Outcomes

Primary Outcomes

Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.

Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.

Secondary Outcomes

  • Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE
  • Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE
  • Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0 in the Subset of Participants Meeting the Criterion at Baseline of OLE
  • Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0/1 in the Subset of Participants Meeting the Criterion at Baseline of OLE
  • Proportion of Participants with an Improvement of their OLE Baseline PASI Score in the Subset of Participants who did not Achieve PASI75 at OLE Baseline
  • Time-to-loss of PASI100 in the Subset of Participants who achieved PASI100 at Baseline of OLE
  • Time-to-loss of PASI90 in the Subset of Participants who achieved PASI90 at Baseline of the OLE
  • PASI Score Over Time
  • IGA Score Over Time

Investigators

Sponsor
Oruka Therapeutics Inc.
Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Research Medical Director

Scientific

Oruka Therapeutics Inc.

Study Sites (8)

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