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

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ORKA-001 — DRUG
  ORKA-001 administered by subcutaneous (SC) injection
• Placebo — OTHER
  Placebo administered by subcutaneous (SC) injection

Study Details

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.

Key Dates

Start date

Dec 3, 2025

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: (Induction Period - Arm 1) ORKA-001
  Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.
• Experimental: (Induction Period - Arm 2) ORKA-001
  Participants will receive 300 mg ORKA-001 per protocol Induction regimen.
• Experimental: (Induction Period - Arm 3) ORKA-001
  Participants will receive 600 mg ORKA-001 per protocol Induction regimen.
• Placebo Comparator: (Induction Period - Arm 4) Placebo
  Participants will receive Placebo per protocol Induction regimen.
• Experimental: (Maintenance Period - Arm 1) ORKA-001
  Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
• Experimental: (Maintenance Period - Arm 2) ORKA-001
  Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
• Placebo Comparator: (Maintenance Period - Arm 3) Placebo
  Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.

Primary Outcome Measure

Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 [ Time Frame: Week 16 ]

Central Contacts

• Oruka Clinical Trials Information
  781-560-0299
  [email protected]

Locations (20)

Find similar trials in Phoenix, AZ

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