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

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

Phase 2 Interventional Oruka Therapeutics, Inc. · NCT07449702

This open-label extension will try ORKA-001 long-term in adults with moderate-to-severe plaque psoriasis who completed a previous ORKA-001 study.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years and up
SexAll
SponsorOruka Therapeutics, Inc. Industry-sponsored
Locations17 sites (Los Angeles, California and 16 other locations)
Trial IDNCT07449702 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with moderate-to-severe plaque psoriasis who completed the preceding ORKA-001 trial and meet baseline health and contraception requirements are the intended participants.

Not a fit: Participants who experienced serious adverse events with ORKA-001 in the prior trial, who developed guttate, erythrodermic, pustular, or drug-induced psoriasis, or who have significant comorbid conditions may not receive benefit or may be excluded from continued treatment.

Why it matters

Potential benefit: If successful, this could show whether ORKA-001 provides sustained skin improvement with an acceptable long-term safety profile for people with moderate-to-severe plaque psoriasis.

How similar studies have performed: Open-label extension programs for other psoriasis biologics have often shown maintained efficacy and tolerability over time, but ORKA-001's long-term results are not yet established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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, 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 this trial is running

Los Angeles, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Plaque PsoriasisPhase 2ORKA-001Open Label ExtensionOLE
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.