Active not recruitingPHASE2INTERVENTIONAL

ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

This study is for adults in the UK with moderate to severe plaque psoriasis. It's testing a new medicine called ORKA-001 against a dummy treatment (placebo) to see how well it works and if it's safe. Psoriasis makes skin red, scaly patches. The study wants to find out if ORKA-001 can help improve these symptoms over about a year. Some people will receive the new medicine, and others will receive the placebo. Nobody will know who is getting what until the study ends. This research helps us understand if ORKA-001 could be a helpful future treatment option for psoriasis.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Oruka Therapeutics, Inc.

Enrolment target

Start

18 Jul 2025

Estimated completion

01 May 2027

Plaque Psoriasis

What is this study about?

This study is looking at a new medicine called ORKA-001 for adults who have a skin condition called plaque psoriasis. Psoriasis causes red, scaly patches on your skin. This study is specifically for people whose plaque psoriasis is considered 'moderate to severe', meaning it affects a noticeable part of their body and significantly impacts their daily life. The main goal is to find out if ORKA-001 can reduce psoriasis symptoms and is safe to use. This kind of study helps doctors understand if a new medicine works before it can be made widely available.

During the study, some people will receive ORKA-001, and others will receive a 'placebo', which looks like the medicine but contains no active drug. This is important because it allows researchers to compare the effects of the new medicine against a dummy treatment to see if any improvements are genuinely due to ORKA-001. Neither you nor your doctor will know whether you are receiving the active medicine or the placebo. This helps ensure fair and unbiased results. The study will last for about a year.

After the first year, participants might have the option to join an 'open-label extension' study. This means that if you choose to continue, you would then know you are receiving ORKA-001 and would keep getting the medicine for a longer period. This extension helps researchers gather more information about the long-term effects and safety of the treatment.

Key takeaways

Tests new medicine ORKA-001 for moderate to severe plaque psoriasis.
Compares ORKA-001 to a dummy treatment (placebo) for effectiveness and safety.
Main study lasts about one year, with a possible extension option.
Participants aged 18 and older with specific psoriasis characteristics.
Close medical monitoring throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with plaque psoriasis for over six months. Your psoriasis needs to be considered 'moderate to severe'. This usually means it covers at least 10% of your body, has a specific score on a doctor's assessment scale (PASI 12 or more), and is rated as moderate or severe by your doctor.

You also need to be someone who could be considered for treatments that affect your whole body or light therapy for your psoriasis. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting.

There are also some reasons why people might not be able to join. For example, if you have other types of psoriasis (like guttate, erythrodermic, or pustular) or if your psoriasis was caused by a medicine. You also can't join if you have a serious medical condition related to your heart, kidneys, liver, or other major body systems, or certain types of infections. If you've had cancer in the last five years (unless it was a mild skin cancer or has been completely cured for five years or more), you also wouldn't be able to take part. Finally, if you're allergic to anything in the ORKA-001 medicine or are pregnant or breastfeeding, the study won't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Have you had plaque psoriasis for at least 6 months?
Is your plaque psoriasis considered moderate to severe?
Are you a suitable candidate for full-body treatments or light therapy for psoriasis?
Are you a woman who is not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve several visits to the study clinic over approximately one year. During these visits, doctors and nurses will assess your psoriasis, take blood samples, and ask you questions about your general health and how you are feeling. You will receive either the study medicine, ORKA-001, or a placebo (dummy medicine) for the first year. The treatments will be given in stages, an 'induction' phase to start, followed by a 'maintenance' phase. After about a year, you may have the option to continue into an 'open-label extension', where everyone receives ORKA-001, for a longer period. The total duration of your participation, including follow-up, will depend on whether you join the extension study.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available and close monitoring of your health by medical professionals. However, there are also potential risks, including side effects from the study medicine, or that the treatment may not work for you. If you receive the placebo, your psoriasis might not improve during the first part of the study. You will be told about all known potential risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

Oruka Therapeutics Investigative Site
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Fountain Valley, United States
Oruka Therapeutics Investigative Site
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Los Angeles, United States
Oruka Therapeutics Investigative Site
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San Diego, United States
Oruka Therapeutics Investigative Site
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Santa Ana, United States
Oruka Therapeutics Investigative Site
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Santa Monica, United States
Oruka Therapeutics Investigative Site
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Cromwell, United States
Oruka Therapeutics Investigative Site
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Coral Gables, United States
Oruka Therapeutics Investigative Site
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Rolling Meadows, United States
Oruka Therapeutics Investigative Site
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Bowling Green, United States
Oruka Therapeutics Investigative Site
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Rockville, United States
Oruka Therapeutics Investigative Site
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Boston, United States
Oruka Therapeutics Investigative Site
Verified postcode
Detroit, United States

Common questions

What is the new medicine, ORKA-001?

ORKA-001 is a new medicine being tested to see if it can help people with moderate to severe plaque psoriasis.

What is a 'placebo' in this study?

A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps compare the new medicine's effects accurately.

How long does the study last?

The main part of the study lasts for about one year. After that, you might have the option to join a longer-term extension study.

Will I know if I'm getting the real medicine or the placebo?

No, during the first year, neither you nor your doctor will know which treatment you are receiving (this is called 'double-blinded').

Can I leave the study if I change my mind?

Yes, you can choose to withdraw from the study at any time, for any reason, without affecting your regular medical care.