A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Oruka Therapeutics, Inc.
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.
Description
This is a multicenter, randomized, double-blinded, placebo-controlled, dose ranging study designed to identify the optimal induction dosing regimen of ORKA-001 in approximately 160 adult participants with moderate-to-severe plaque psoriasis. The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-001 compared to placebo and will include 3 maintenance regimens. The study will consist of 4 periods: * Screening Period of up to 6 weeks * Induction Period of up to 28 weeks (Day 1 \[Baseline\] to Week 28) * Maintenance Period of up to approximately 72 weeks (Week 28…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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, h…
Interventions
- DrugORKA-001
ORKA-001 administered by subcutaneous (SC) injection
- OtherPlacebo
Placebo administered by subcutaneous (SC) injection
Locations (26)
- Oruka Therapeutics Investigative SitePhoenix, Arizona
- Oruka Therapeutics Investigative SiteNorth Little Rock, Arkansas
- Oruka Therapeutics Investigative SiteLos Angeles, California
- Oruka Therapeutics Investigative SiteLos Angeles, California
- Oruka Therapeutics Investigative SiteSan Diego, California
- Oruka Therapeutics Investigative SiteCoral Gables, Florida