ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis
NCT07090330 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-03-17
Summary
This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
Conditions
Interventions
- DRUG
-
ORKA-001 Induction Dose
ORKA-001 Induction Dose, administered by subcutaneous (SC) injection
- OTHER
-
Placebo
Placebo administered by subcutaneous (SC) injection
- DRUG
-
ORKA-001 Maintenance Dose
ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection
Sponsors & Collaborators
-
Oruka Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-18
- Primary Completion
- 2026-04-30
- Completion
- 2027-05-31
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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