Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
NCT ID: NCT07290569
Last Updated: 2025-12-18
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
160 participants
INTERVENTIONAL
2025-12-03
2028-12-31
Brief Summary
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Detailed Description
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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 to Week 100)
* Post-treatment Follow-up Period: Participants will have the option to enter the open-label extension (OLE) study. Participants who opt out of the OLE study and/or withdraw from the study must be followed for 48 weeks after the End of Treatment (EOT)/Early Termination (ET) visit.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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(Maintenance Period - Arm 2) ORKA-001
Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
ORKA-001
ORKA-001 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
(Induction Period - Arm 1) ORKA-001
Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.
ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
(Induction Period - Arm 2) ORKA-001
Participants will receive 300 mg ORKA-001 per protocol Induction regimen.
ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
(Induction Period - Arm 3) ORKA-001
Participants will receive 600 mg ORKA-001 per protocol Induction regimen.
ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
(Induction Period - Arm 4) 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 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Interventions
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ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Placebo
Placebo 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
Phoenix, Arizona, United States
Oruka Therapeutics Investigative Site
North Little Rock, Arkansas, United States
Oruka Therapeutics Investigative Site
Coral Gables, Florida, United States
Oruka Therapeutics Investigative Site
Mason, Ohio, United States
Oruka Therapeutics Investigative Site
Portland, Oregon, United States
Oruka Therapeutics Investigative Site
Portland, Oregon, United States
Oruka Therapeutics Investigative Site
Houston, Texas, United States
Oruka Therapeutics Investigative Site
Webster, Texas, United States
Oruka Therapeutics Investigative Site
Norfolk, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Oruka Investigative Site
Role: primary
Oruka Investigative Site
Role: primary
Oruka Investigative Site
Role: primary
Oruka Investigative Site
Role: primary
Oruka Investigative Site
Role: primary
Oruka Investigative Site
Role: primary
Oruka Investigative Site
Role: primary
Oruka Investigative Site
Role: primary
Oruka Investigative Site
Role: primary
Other Identifiers
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ORKA-001-114
Identifier Type: -
Identifier Source: org_study_id