Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• ORKA-002 — DRUG
  ORKA-002 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-002 in adult participants with moderate-to-severe plaque psoriasis.

Key Dates

Start date

Mar 19, 2026

Status verified

May 2026

Primary completion

Oct 31, 2027

Completion

Apr 30, 2029

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: (Induction Period - Arm 1) ORKA-002
  Participants will receive ORKA-002 per protocol Induction regimen.
• Experimental: (Induction Period - Arm 2) ORKA-002
  Participants will receive ORKA-002 per protocol Induction regimen.
• Experimental: (Induction Period - Arm 3) ORKA-002
  Participants will receive ORKA-002 per protocol Induction regimen.
• Placebo Comparator: (Induction Period - Arm 4) Placebo
  Participants will receive Placebo per protocol Induction regimen.

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 (22)

Find similar trials in Birmingham, AL

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