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ORKA-001 in Patients with Moderate-to-Severe Plaque Psoriasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being done in people with moderate-to-severe plaque psoriasis, a long-term skin condition that causes raised, red, scaly patches on the skin. The treatment being tested is ORKA-001, given as a subcutaneous injection under the skin. A placebo is also used in the study. The purpose of the study is to find the best dose of ORKA-001 and to compare it with placebo.

People in the study are assigned by chance to receive either ORKA-001 or placebo. The study is double-blinded, which means that the people taking part and the study staff do not know which treatment is given. Treatment is given over time, and the skin condition is checked during the study to see how well the symptoms improve and how long any improvement lasts.

The study also looks at safety, including possible side effects and changes in health checks such as blood tests and heart tracing. The full study lasts up to about 100 weeks.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study entry and treatment assignment
After you join the study, you are assigned by chance to receive either orka-001 or placebo. a placebo is an inactive treatment that looks like the study medicine but does not contain the active drug.
The study is double-blinded, which means that neither you nor the study staff know which treatment you receive during the study.
Step 2
Study treatment period
If you receive orka-001, the study medicine is given as a subcutaneous injection, which means an injection under the skin.
Each dose of orka-001 is 600 mg.
The study lasts through week 100, and treatment and follow-up are assessed during this period.
The exact dosing frequency and total number of injections are not stated in the source data.
Step 3
Skin and symptom assessments
Your psoriasis is checked during the study using the pasi score. pasi stands for psoriasis area and severity index, which is a score that measures how much of your skin is affected and how severe the psoriasis is. the score ranges from 0 to 72.
Your psoriasis is also checked using the iga, which stands for investigator global assessment. this is a rating of how clear or severe your psoriasis looks. the scale goes from 0 for clear to 4 for severe.
Step 4
Week 16 assessment
At week 16, your response to treatment is measured.
The main result is whether your pasi score has dropped by 100%, which means no visible psoriasis signs are left by this measure.
Other results at week 16 include whether your iga score is 0 (clear), whether your pasi score has dropped by 90%, and whether your iga score is 0 or 1 (clear or almost clear).
Step 5
Safety monitoring during the study
From day 1 through week 100, you are monitored for treatment-emergent adverse events, which means side effects or other unwanted medical problems that appear after treatment starts.
You are also monitored for treatment-emergent adverse events of special interest, which are side effects that the study pays extra attention to.
Your vital signs, blood and other laboratory test results, and electrocardiograms are checked for important changes. an electrocardiogram is a test that records the electrical activity of the heart.
Step 6
Week 100 assessment
At week 100, your psoriasis response is checked again.
The study looks at whether you still have a 100% reduction in pasi score, whether your iga score remains 0 (clear), whether your pasi score remains reduced by 90%, whether your iga score remains 0 or 1 (clear or almost clear), and whether your pasi score remains reduced by 75%.

Who can join the trial?

7 criteria

Be at least 18 years old.
Have a diagnosis of plaque psoriasis for more than 6 months.
Have moderate-to-severe chronic plaque psoriasis, meaning all of the following must be true:
- BSA of at least 10% (BSA means the body surface area, or how much of the skin is affected).
- PASI of at least 12 (PASI is a score that measures how severe the psoriasis is).
- IGA score of at least 3 on a 5-point scale (IGA is a doctor’s overall rating of the skin condition).
- Be a candidate for systemic therapy or phototherapy, meaning the person may need treatment that works throughout the body or treatment using light.
- If the participant is a woman who can become pregnant, she must have a negative pregnancy test.

Who cannot join the trial?

5 criteria

Having a type of psoriasis that is not plaque psoriasis, including guttate psoriasis (small drop-like spots), erythrodermic psoriasis (widespread redness and scaling), or pustular psoriasis (pus-filled bumps), or having drug-induced psoriasis (psoriasis caused by a medicine).
Having a significant past or current problem with the metabolism (how the body uses and stores energy), skin other than psoriasis, liver, kidneys, blood, lungs, heart, stomach or intestines, nerves, breathing system, hormones, or mental health, or having any infectious disease (an illness caused by germs such as bacteria, viruses, or fungi).
Having a history of malignancy (cancer), except for non-melanoma skin cancer or cancer that was completely treated at least 5 years ago and has not come back.
Having a known hypersensitivity (allergic reaction) to any ingredient in the ORKA-001 study medicine.
Being a woman who is breastfeeding or plans to breastfeed during the study.

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Verified sites

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Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
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Goethe University Frankfurt
Frankfurt, Germany
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Hospital De La Santa Creu I Sant Pau
Barcelona, Spain

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Investigated drugs

ORKA-001 is the study medicine being tested in this trial. It is given as a shot under the skin. The trial is looking at whether it can help reduce the signs and symptoms of moderate-to-severe plaque psoriasis, and which treatment plan gives the best balance of benefit and risk.

What is already known about the treatment

ORKA-001 - ORKA-001 is given as a solution for subcutaneous injection, which means it is injected under the skin. It is an investigational medicine, so its full role in medical practice and medical literature is still being studied and is not yet established. It is being tested for moderate-to-severe plaque psoriasis, a long-lasting skin disease that causes red, scaly, and inflamed patches, and it is classified as an experimental anti-psoriasis biologic medicine. At the molecular level, it is designed to act on specific immune signals that help drive skin inflammation, with the goal of reducing the overactive immune response and improving skin symptoms.

Investigated diseases

Plaque Psoriasis - Plaque psoriasis is a long-lasting skin disease that causes raised, red patches covered with thick, silvery scales. The patches often develop on the elbows, knees, scalp, and lower back, but they can appear anywhere on the body. The disease usually comes and goes in periods of worsening and improvement. In more severe forms, the patches may cover larger areas of skin and become thicker, more widespread, and more uncomfortable.