ORKA-001 for Plaque Psoriasis

(EVERLAST-B Trial)

Recruiting at 7 trial locations

Overseen By Oruka Clinical Trials Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oruka Therapeutics, Inc.

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe plaque psoriasis. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

My psoriasis is severe, covering more than 10% of my body.

I am eligible for treatment with medication or light therapy.

Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria

I have a significant history of certain health conditions.

I had cancer before, but it was either skin cancer not including melanoma, or any cancer cured over 5 years ago with no recurrence.

Participants with a known hypersensitivity to any components of the ORKA-001 drug product

What Are the Treatments Tested in This Trial?

Interventions

• ORKA-001

Trial Overview

The trial is testing ORKA-001 at different doses to see how well it works compared to a placebo. It's conducted across multiple centers where patients are randomly assigned to either the drug or placebo without knowing which one they receive (double-blinded).

How Is the Trial Designed?

Group I: (Maintenance Period - Arm 2) ORKA-001 Experimental Treatment 1 Intervention

Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.

Group II: (Maintenance Period - Arm 1) ORKA-001 Experimental Treatment 1 Intervention

Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.

Group III: (Induction Period - Arm 3) ORKA-001 Experimental Treatment 1 Intervention

Participants will receive 600 mg ORKA-001 per protocol Induction regimen.

Group IV: (Induction Period - Arm 2) ORKA-001 Experimental Treatment 1 Intervention

Participants will receive 300 mg ORKA-001 per protocol Induction regimen.

Group V: (Induction Period - Arm 1) ORKA-001 Experimental Treatment 1 Intervention

Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.

Group VI: (Induction Period - Arm 4) Placebo Placebo Group 1 Intervention

Participants will receive Placebo per protocol Induction regimen.

Group VII: (Maintenance Period - Arm 3) Placebo Placebo Group 1 Intervention

Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.

Who Is Running the Clinical Trial?

Oruka Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

20+