ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis
NCT ID: NCT07090330
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-07-18
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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(Induction Period) ORKA-001
Participants will receive ORKA-001 per protocol Induction regimen.
ORKA-001 Induction Dose
ORKA-001 Induction Dose, administered by subcutaneous (SC) injection
(Induction Period) Placebo
Participants will receive Placebo per protocol Induction regimen.
Placebo
Placebo administered by subcutaneous (SC) injection
(Maintenance Period - Arm 1) ORKA-001
Participants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
ORKA-001 Maintenance Dose
ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection
(Maintenance Period - Arm 2) ORKA-001
Participants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
ORKA-001 Maintenance Dose
ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection
(Maintenance Period - Arm 3) Placebo
Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.
Placebo
Placebo administered by subcutaneous (SC) injection
Interventions
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ORKA-001 Induction Dose
ORKA-001 Induction Dose, administered by subcutaneous (SC) injection
Placebo
Placebo administered by subcutaneous (SC) injection
ORKA-001 Maintenance Dose
ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Oruka Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Oruka Therapeutics Investigative Site
Fountain Valley, California, United States
Oruka Therapeutics Investigative Site
Los Angeles, California, United States
Oruka Therapeutics Investigative Site
San Diego, California, United States
Oruka Therapeutics Investigative Site
Santa Ana, California, United States
Oruka Therapeutics Investigative Site
Santa Monica, California, United States
Oruka Therapeutics Investigative Site
Cromwell, Connecticut, United States
Oruka Therapeutics Investigative Site
Coral Gables, Florida, United States
Oruka Therapeutics Investigative Site
Rolling Meadows, Illinois, United States
Oruka Therapeutics Investigative Site
Bowling Green, Kentucky, United States
Oruka Therapeutics Investigative Site
Rockville, Maryland, United States
Oruka Therapeutics Investigative Site
Boston, Massachusetts, United States
Oruka Therapeutics Investigative Site
Detroit, Michigan, United States
Oruka Therapeutics Investigative Site
New York, New York, United States
Oruka Therapeutics Investigative Site
New York, New York, United States
Oruka Therapeutics Investigative Site
Portland, Oregon, United States
Oruka Therapeutics Investigative Site
Norfolk, Virginia, United States
Oruka Therapeutics Investigative Site
Milwaukee, Wisconsin, United States
Oruka Therapeutics Investigative Site
Edmonton, Alberta, Canada
Oruka Therapeutics Investigative Site
Edmonton, Alberta, Canada
Oruka Therapeutics Investigative Site
Surrey, British Columbia, Canada
Oruka Therapeutics Investigative Site
Hamilton, Ontario, Canada
Oruka Therapeutics Investigative Site
London, Ontario, Canada
Oruka Therapeutics Investigative Site
Markham, Ontario, Canada
Oruka Therapeutics Investigative Site
Peterborough, Ontario, Canada
Oruka Therapeutics Investigative Site
Toronto, Ontario, Canada
Oruka Therapeutics Investigative Site
Waterloo, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ORKA-001-112
Identifier Type: -
Identifier Source: org_study_id
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