Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
This research study is looking into a new medicine called ORKA-001 for adults who have moderate to severe plaque psoriasis. The main goal is to find the most effective and safest dose of ORKA-001. Participants will be randomly assigned to receive different doses of ORKA-001 or a placebo (a dummy treatment). Scientists will compare how well the different doses of ORKA-001 work and whether they cause any side effects. The study will last for a long time, starting with an initial treatment period, followed by a longer maintenance period, and then a follow-up to see how people are doing after treatment.
At a glance
What is this study about?
This study is investigating a new medication called ORKA-001 for adult patients who have a skin condition known as plaque psoriasis. Psoriasis can cause patches of red, scaly skin and can sometimes be uncomfortable or affect daily life. This particular study is for people whose psoriasis is considered 'moderate to severe', meaning it covers a significant part of their body or is very bothersome.
The main purpose of this research is to figure out the best dose of ORKA-001. This is important because finding the right amount of medicine can help it work most effectively while keeping potential side effects to a minimum. The study will also carefully check if ORKA-001 actually helps improve psoriasis symptoms and if it causes any unwanted side effects, comparing it to a placebo (a treatment that looks like the study drug but contains no active medicine).
Everyone in the study will be randomly assigned to one of several groups. Some groups will receive different doses of ORKA-001, and one group will receive the placebo. Neither you nor your study doctor will know which treatment you are getting; this is done to ensure the results are as unbiased as possible. Over a long period, typically over two years, researchers will monitor your condition and health closely. This detailed observation helps them understand the full effects of ORKA-001.
Key takeaways
- This study is for adults with moderate to severe plaque psoriasis.
- It's testing a new medicine called ORKA-001, comparing it to a placebo.
- The main aim is to find the best dose of ORKA-001 and check its safety and effectiveness.
- Participants will not know if they are receiving ORKA-001 or placebo.
- The study involves a long-term commitment, potentially lasting over two years.
- Regular clinic visits and health monitoring will be part of taking part.
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 moderate to severe, which means it covers at least 10% of your body, has a specific score on standard psoriasis assessment tools (PASI 12 or more, and IGA 3 or more), and your doctor believes you would generally be a candidate for stronger treatments like pills or light therapy.
There are also some reasons why you might not be able to join. For instance, if you have other types of psoriasis (like guttate, erythrodermic, or pustular) or psoriasis caused by medication, this study won't be right for you. If you have serious health problems affecting your metabolism, heart, lungs, liver, kidneys, or mental health, or a history of cancer (unless it was a mild skin cancer treated successfully a long time ago), you likely won't be eligible.
Also, if you are allergic to any part of the ORKA-001 medicine or if you are pregnant, planning to become pregnant, or breastfeeding, you cannot take part. Women who could get pregnant will need a negative pregnancy test before starting.
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 old or older?
- Do you have plaque psoriasis that has been diagnosed for more than 6 months?
- Is your plaque psoriasis considered moderate to severe?
- Has your doctor suggested you might need stronger treatments for your psoriasis (like pills or light therapy)?
- Are you NOT pregnant or breastfeeding, and not planning to become pregnant during the study?
- Do you NOT have other serious health conditions or certain types of psoriasis?
What does participation involve?
If you decide to take part in this study, it will be a long process, lasting for up to about two years. It starts with a 'screening period' of up to six weeks where doctors will check if you're suitable for the study. If you fit the criteria, you'll then enter the 'induction period' which lasts for 28 weeks. During this time, you'll receive either ORKA-001 or a dummy treatment.
After that, there's a much longer 'maintenance period' that could last for up to 72 weeks. During these periods, you'll have regular visits to the study clinic for check-ups, assessments of your psoriasis, and to receive your study medication. The study team will closely monitor your health and any side effects you might experience.
Once your active treatment in the study ends, there's a 'post-treatment follow-up period'. You might have the option to join another part of the study, called an 'open-label extension', where you would continue to receive ORKA-001. If you choose not to, or if you leave the study early, you'll still need to have follow-up checks for 48 weeks after your treatment finishes to ensure your health is stable.
Potential risks and benefits
Locations (36)
- Oruka Therapeutics Investigative SiteVerified postcodePhoenix, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeNorth Little Rock, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeLos Angeles, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeLos Angeles, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeSan Diego, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeCoral Gables, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeRolling Meadows, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodePlainfield, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeRockville, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeKew Gardens, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeChapel Hill, United States· Recruiting
- Oruka Therapeutics Investigative SiteVerified postcodeCleveland, United States· Recruiting
Common questions
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know. This is called 'double-blinded' and helps ensure the study results are fair and unbiased.
How long will I need to be in the study?
The study involves different stages, and if you take part in all of them, it could last for about two years or more, including follow-up checks.
What does 'dose ranging' mean?
It means the study is testing different amounts (doses) of the new medicine to find out which dose works best and is safest for treating psoriasis.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting your regular medical care. However, you would still need to complete some follow-up checks.
How to find out more
Oruka Clinical Trials Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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