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Clinical Trials in Germany / NCT07290569
Active, not recruiting Phase 2

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

NCT07290569 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2025-12-03
Last updated
2026-08-17

Condition(s) studied

Plaque Psoriasis

Investigational drug(s) / intervention(s)

ORKA-001 →Placebo

ORKA-001: ORKA-001 administered by subcutaneous (SC) injection

Placebo: Placebo administered by subcutaneous (SC) injection

Study summary

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Oruka Therapeutics Investigative Site Phoenix Arizona
Oruka Therapeutics Investigative Site North Little Rock Arkansas
Oruka Therapeutics Investigative Site Los Angeles California
Oruka Therapeutics Investigative Site Los Angeles California
Oruka Therapeutics Investigative Site San Diego California
Oruka Therapeutics Investigative Site Miami Florida
Oruka Therapeutics Investigative Site Rolling Meadows Illinois
Oruka Therapeutics Investigative Site Plainfield Indiana
Oruka Therapeutics Investigative Site Rockville Maryland
Oruka Therapeutics Investigative Site Kew Gardens New York
Oruka Therapeutics Investigative Site Chapel Hill North Carolina
Oruka Therapeutics Investigative Site Cleveland Ohio
Oruka Therapeutics Investigative Site Mason Ohio
Oruka Therapeutics Investigative Site Portland Oregon
Oruka Therapeutics Investigative Site Portland Oregon
Oruka Therapeutics Investigative Site Philadelphia Pennsylvania
Oruka Therapeutics Investigative Site Frisco Texas
Oruka Therapeutics Investigative Site Houston Texas
Oruka Therapeutics Investigative Site Webster Texas
Oruka Therapeutics Investigative Site Norfolk Virginia
Oruka Therapeutics Investigative Site Surrey British Columbia
Oruka Therapeutics Investigative Site Surrey British Columbia
Oruka Therapeutics Investigative Site Fredericton New Brunswick
Oruka Therapeutics Investigative Site Ajax Ontario
Oruka Therapeutics Investigative Site Markham Ontario
Oruka Therapeutics Investigative Site Peterborough Ontario
Oruka Therapeutics Investigative Site Montreal Quebec
Oruka Therapeutics Investigative Site Québec Quebec
Oruka Therapeutics Investigative Site Heidelberg Baden-Wuerrtemberg
Oruka Therapeutics Investigative Site Frankfurt am Main Hesse
Oruka Therapeutics Investigative Site Bad Bentheim Lower Saxony
Oruka Therapeutics Investigative Site Kiel Schleswig-Holstein
Oruka Therapeutics Investigative Site Badalona Barcelona
Oruka Therapeutics Investigative Site Barcelona Barcelona
Oruka Therapeutics Investigative Site Madrid Madrid
Oruka Therapeutics Investigative Site Madrid Madrid

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07290569 on ClinicalTrials.gov ↗ ← All trials in Germany