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Finding the right dose of ORKA-001 for adults with moderate-to-severe plaque psoriasis.

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

Phase 2 Interventional Oruka Therapeutics, Inc. · NCT07290569

This trial will test different doses of ORKA-001 versus placebo in adults with moderate-to-severe plaque psoriasis to see which dose works best.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years and up
SexAll
SponsorOruka Therapeutics, Inc. Industry-sponsored
Locations26 sites (Phoenix, Arizona and 25 other locations)
Trial IDNCT07290569 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blinded, placebo-controlled, dose-ranging Phase 2 trial will enroll about 160 adults with moderate-to-severe plaque psoriasis to identify optimal induction dosing of ORKA-001. Participants are randomized to one of three induction regimens or placebo and then assigned to one of three maintenance regimens. The protocol includes a screening period up to 6 weeks, an induction period up to 28 weeks, a maintenance period through week 100, and an optional open-label extension with 48-week follow-up for those who do not enter the extension. Safety and skin-response measures (including PASI, BSA, and IGA) will be collected throughout.

Who should consider this trial

Good fit: Adults aged 18 or older with plaque psoriasis for more than 6 months who have moderate-to-severe disease (BSA ≥ 10%, PASI ≥ 12, IGA ≥ 3) and are candidates for systemic therapy or phototherapy.

Not a fit: Patients with non-plaque forms of psoriasis, significant uncontrolled medical conditions, recent or active malignancy (except select treated cases), known hypersensitivity to ORKA-001 components, or who are pregnant or breastfeeding may not benefit or be eligible.

Why it matters

Potential benefit: If successful, ORKA-001 could offer a new effective dosing option that improves skin clearance for people with moderate-to-severe plaque psoriasis.

How similar studies have performed: Dose-ranging trials and multiple classes of psoriasis treatments have previously identified effective dosing regimens and improved outcomes, but ORKA-001 itself is a novel investigational agent.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants ≥ 18 years of age
2. Have a diagnosis of plaque psoriasis for \> 6 months
3. Have moderate-to-severe chronic plaque psoriasis defined as:

   1. BSA ≥ 10%, and
   2. PASI ≥ 12, and
   3. IGA score of ≥ 3 on a 5-point scale
4. Candidate for systemic therapy or phototherapy
5. Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
2. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease
3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
4. A known hypersensitivity to any components of the ORKA-001 drug product
5. Women who are breastfeeding or plan to breastfeed during the study

Where this trial is running

Phoenix, Arizona and 25 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-001Plaque psoriasis
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.