Open Actively Recruiting

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

About

Brief 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.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.
Study Stats
Protocol No.
26-0989
Category
Autoimmune Disorders
Principal Investigator
April W. Armstrong, MD, MPH
April W. Armstrong, MD, MPH
Dermatology
April W. Armstrong, MD, MPH
Contact
  • Yvonne Nong
  • Hamida Askaryar
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT07449702
For detailed technical eligibility, visit ClinicalTrials.gov.