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ORKA-002 dose-ranging test for adults with moderate-to-severe plaque psoriasis

A Multicenter, Randomized, Double-Blinded, Placebo- Controlled, Dose-Range Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Participants With Moderate-to-Severe Plaque Psoriasis

Phase 2 Interventional Oruka Therapeutics, Inc. · NCT07474792

This will test three different induction doses of ORKA-002 versus placebo in adults with moderate-to-severe plaque psoriasis to find the best dose.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years to 79 Years
SexAll
SponsorOruka Therapeutics, Inc. Industry-sponsored
Locations27 sites (Birmingham, Alabama and 26 other locations)
Trial IDNCT07474792 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled phase 2 dose-ranging study will enroll about 160 adults with moderate-to-severe plaque psoriasis to identify an optimal induction dosing regimen of ORKA-002. Participants will be randomized to one of three ORKA-002 induction regimens or placebo and will go through screening, an induction treatment period, and a post-treatment follow-up period. The study will measure efficacy and safety outcomes comparing each dose group to placebo. Standard psoriasis severity scales and safety monitoring will be used throughout the trial.

Who should consider this trial

Good fit: Adults aged 18 to under 80 with at least 6 months of plaque psoriasis who have moderate-to-severe disease (BSA ≥10%, PASI ≥12, IGA ≥3) and are candidates for systemic therapy or phototherapy are ideal candidates.

Not a fit: People with nonplaque forms of psoriasis, significant uncontrolled medical conditions, a recent history of malignancy, known hypersensitivity to the drug components, or who cannot meet pregnancy-test requirements may not benefit or be eligible.

Why it matters

Potential benefit: If successful, ORKA-002 could offer an effective new dosing option that reduces psoriasis symptoms with an acceptable safety profile.

How similar studies have performed: Other systemic and biologic treatments for plaque psoriasis have shown substantial benefit, but ORKA-002 itself is still in early-phase testing with this dose-ranging phase 2 trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants ≥ 18 and \< 80 years of age at the time of consent
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-002 drug product
5. Women who are breastfeeding or plan to breastfeed during the study

Where this trial is running

Birmingham, Alabama and 26 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 2Plaque psoriasisORKA-002
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.