Long-term ORKA-001 treatment for adults with plaque psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label extension follows adults who completed a prior ORKA-001 study to gather longer-term data on safety and skin response. Participants may receive ORKA-001 for up to approximately 96 weeks of treatment, followed by about 48 weeks of post-treatment follow-up after the last study visit. Regular clinic visits will include safety labs, adverse event monitoring, and assessments of psoriasis symptoms and skin clearance. Enrollment is limited to those who successfully completed the preceding trial and meet baseline health and contraception requirements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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.

Where it's running

• Oruka Therapeutics Investigative Site
  Phoenix, Arizona, United States Recruiting
• Oruka Therapeutics Investigative Site
  North Little Rock, Arkansas, United States Recruiting
• Oruka Therapeutics Investigative Site
  Fountain Valley, California, United States Recruiting
• Oruka Therapeutics Investigative Site
  Los Angeles, California, United States Recruiting
• Oruka Therapeutics Investigative Site
  Los Angeles, California, United States Recruiting
• Oruka Therapeutics Investigative Site
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Oruka Clinical Trials Information
• Email: clinicaltrials@orukatx.com
• Phone: 781-560-0299

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.