160 Participants NeededMy employer runs this trial

ORKA-002 for Plaque Psoriasis

Recruiting at 64 trial locations
OC
Overseen ByOruka Clinical Trials Information
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Oruka Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ORKA-002, a potential drug, to determine its safety and effectiveness for people with moderate-to-severe plaque psoriasis. Participants will receive either ORKA-002 or a placebo, a look-alike treatment with no active ingredient, to compare results. The trial seeks participants who have had plaque psoriasis for more than six months and find it affects at least 10% of their body. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ORKA-002 is likely to be safe for humans?

Research has shown that ORKA-002 has been safe so far. In earlier studies, participants tolerated ORKA-002 well, with no major side effects reported. Most people did not experience serious health problems after taking it. The treatment remains in the body for an extended period, potentially reducing the number of doses needed. This can be more convenient for patients compared to treatments requiring more frequent administration. Overall, the data suggest that ORKA-002 is safe for humans, but ongoing studies will continue to monitor its safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for plaque psoriasis, which often include topical corticosteroids, biologics, and systemic therapies, ORKA-002 is unique because it potentially offers a new mechanism of action. Researchers are excited about ORKA-002 as it targets specific pathways involved in the inflammatory process, aiming to reduce the symptoms of psoriasis more effectively. This innovative approach could provide an alternative for patients who do not respond well to current therapies, offering hope for better management of their condition.

What evidence suggests that ORKA-002 might be an effective treatment for plaque psoriasis?

Research has shown that ORKA-002 could be a promising treatment for moderate-to-severe plaque psoriasis. Early results suggest that this treatment might be effective with just two doses a year, as it remains active in the body for about 75-80 days. This prolonged effect may help maintain consistent control over psoriasis symptoms. In this trial, participants will receive ORKA-002 in different arms to evaluate its effectiveness. The treatment aims to significantly improve skin symptoms compared to a placebo. Although human studies have provided limited data so far, the initial findings are encouraging.12367

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to under 80 with moderate-to-severe plaque psoriasis (covering at least 10% of their body and a PASI score of at least 12) who have had the condition for over 6 months and are eligible for systemic or light-based therapy. Women able to become pregnant must test negative first.

Inclusion Criteria

3. IGA score of ≥ 3 on a 5-point scale
I am between 18 and 79 years old.
I have had plaque psoriasis for more than 6 months.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive ORKA-002 or placebo per protocol induction regimen

16 weeks

Post-treatment Follow-up

Participants are monitored for safety and effectiveness after treatment

32 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ORKA-002

Trial Overview

The study compares different doses of a new drug, ORKA-002, against a placebo in people with moderate-to-severe plaque psoriasis. Participants are randomly assigned to groups and neither they nor the researchers know which treatment they're getting.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: (Induction Period - Arm 3) ORKA-002Experimental Treatment1 Intervention
Group II: (Induction Period - Arm 2) ORKA-002Experimental Treatment1 Intervention
Group III: (Induction Period - Arm 1) ORKA-002Experimental Treatment1 Intervention
Group IV: (Induction Period - Arm 4) PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oruka Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
20+

Citations

Release Details - Investor Relations | Oruka Therapeutics, Inc.

ORKA-002 interim Phase 1 data demonstrates a half-life of 75-80 days supporting potential for twice-per-year dosing in psoriasis and ...

Dose Ranging Study of ORKA-002 in Patients With ...

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult ...

Oruka Reports Positive Interim Phase 1 Data for ORKA-002 ...

Phase 2 trials for ORKA-002 will explore its efficacy in plaque psoriasis and hidradenitis suppurativa, focusing on twice-yearly dosing. ORKA ...

102 Characterization of ORKA-002, a ...

Early treatment may provide more favorable outcomes, including prevention of comorbidity progression. G-EPOSS, a prospective, non interventional, multicenter ...

ORKA-002 Psoriasis Trial Progress: What Oruka's New ...

A placebo shot is also used so doctors and patients can compare results and see if ORKA-002 truly improves skin symptoms beyond background noise ...

Oruka Therapeutics Announces Preclinical Data for ORKA ...

ORKA-002 has an NHP half-life of more than 30 days following subcutaneous and intravenous administration, over three times longer than ...

Dose Ranging Study of ORKA-002 in Patients With Moderate ...

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult ...