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Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis

RecruitingPhase 2

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

Who can join

Ages 18 to 79 · All sexes

Full eligibility 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

About the study

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.

What is being tested

Sponsor: Oruka Therapeutics, Inc. · Participants: 160 · Started: Mar 19, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07474792

Locations in the U.S.

AlabamaOruka Therapeutics Investigative Site, Birmingham
ArizonaOruka Therapeutics Investigative Site, Phoenix
CaliforniaOruka Therapeutics Investigative Site, Fountain Valley
Oruka Therapeutics Investigative Site, Los Angeles
Oruka Therapeutics Investigative Site, San Diego
Oruka Therapeutics Investigative Site, Santa Ana
Oruka Therapeutics Investigative Site, Santa Monica
ConnecticutOruka Therapeutics Investigative Site, Cromwell
FloridaOruka Therapeutics Investigative Site, Miami
IllinoisOruka Therapeutics Investigative Site, Rolling Meadows
MassachusettsOruka Therapeutics Investigative Site, Boston
Oruka Therapeutics Investigative Site, Milford
MichiganOruka Therapeutics Investigative Site, Ann Arbor
Oruka Therapeutics Investigative Site, Detroit
Oruka Therapeutics Investigative Site, Warren
MinnesotaOruka Therapeutics Investigative Site, New Brighton
NebraskaOruka Therapeutics Investigative Site, Omaha
New YorkOruka Therapeutics Investigative Site, Elmhurst
Oruka Therapeutics Investigative Site, New York
North CarolinaOruka Therapeutics Investigative Site, Wilmington
OhioOruka Therapeutics Investigative Site, Bexley
OregonOruka Therapeutics Investigative Site, Portland
Oruka Therapeutics Investigative Site, Warrenton
South CarolinaOruka Therapeutics Investigative Site, Charleston
TexasOruka Therapeutics Investigative Site, Dallas
Oruka Therapeutics Investigative Site, Dallas
Oruka Therapeutics Investigative Site, Houston
Oruka Therapeutics Investigative Site, Webster
WashingtonOruka Therapeutics Investigative Site, Mill Creek

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.