Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

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

Details

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.

Keywords

Plaque Psoriasis, Phase 2, ORKA-001, Open Label Extension, OLE, ORKA-001 Twice Yearly

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  1. 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
  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

  • Oruka Therapeutics Investigative Site accepting new patients
    Santa Monica California 90403 United States
  • Oruka Therapeutics Investigative Site accepting new patients
    Los Angeles California 90045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Oruka Therapeutics, Inc.
Links
Sign up for this study
ID
NCT07449702
Phase
Phase 2 Psoriasis Research Study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated