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Long-term Safety and Efficacy of ORKA-001 in Adults with Moderate-to-Severe Plaque Psoriasis (Open-Label Extension Study)

Verified siteInvestigationalNo placebo

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What is this trial about?

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

Moderate-to-severe Plaque Psoriasis is a skin condition that causes thick, red patches covered with silvery scales, often affecting large areas of the body and causing itching or pain. The study uses a medication called ORKA-001, given as a subcutaneous injection (a shot under the skin) at a dose of 600 mg, to see how it works over a long period.

The main aim of the research is to evaluate the long‑term safety of the treatment. Participants receive the injection at regular intervals and attend clinic visits where doctors check for any side effects, take blood samples, measure vital signs, and perform simple heart tests called electrocardiograms (ECGs). The study is open‑label, meaning everyone knows the medication being used, and it continues for many months to gather enough information.

Effectiveness is looked at by seeing how many people keep very clear skin, using scores such as PASI100 (complete clearance), PASI90 (90 % improvement), and the IGA score (a doctor’s overall rating of the skin). These scores help show whether the skin stays improved over time. The study records these results at each visit to understand the durability of the benefit.

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
Initial enrollment visit
You attend the first study visit after agreeing to join the trial. during this visit, study staff confirm that you meet the eligibility criteria for moderate-to-severe plaque psoriasis.
You provide written consent, and the team records your medical history, current medications, and any allergies.
Step 2
Baseline assessments
A series of baseline measurements are taken before any medication is given. these include vital signs (blood pressure, heart rate), a physical examination, laboratory blood tests, and an electrocardiogram (a test that records the electrical activity of the heart).
Your psoriasis severity is evaluated using the PASI score (a numeric measure of plaque area and redness) and the Investigator's Global Assessment (IGA), which rates overall skin condition.
Step 3
First dose administration
You receive the first dose of ORKA-001. the medication is a subcutaneous injection (injected under the skin) of 600 mg provided as a solution for injection.
The injection is given by a trained study professional in a private setting.
Step 4
Regular follow‑up visits and repeat dosing
You return to the study site at scheduled intervals (the exact timing is defined by the study protocol). at each visit, the following occurs:
- safety checks, including vital signs, laboratory blood tests, and an electrocardiogram, to monitor any side effects;
- assessment of psoriasis severity using the PASI score and IGA to track improvement;
- administration of the next dose of ORKA-001 (600 mg subcutaneous injection) as directed by the protocol.
Step 5
Ongoing treatment period
You continue to receive the scheduled injections of ORKA-001 for the duration of the study, which may extend for several years up to the study end date of July 1, 2030.
Throughout this period, the study team regularly monitors your safety and the effectiveness of the medication, recording any adverse events or changes in your health.
Step 6
Final study visit
At the conclusion of the trial, you attend a final visit where the same safety assessments (vital signs, lab tests, electrocardiogram) and psoriasis evaluations (PASI and IGA) are performed.
The study team reviews all collected data to evaluate the long‑term safety and tolerability of ORKA-001.

Who can join the trial?

4 criteria

Signed informed consent: you must have signed a document that shows you understand the study and agree to take part.
You must have finished the earlier trial successfully without major problems.
If you are a woman who could become pregnant, you need a negative urine pregnancy test at the start of this study.
If you are a woman who could become pregnant, or a man who can father children and has a partner who could become pregnant, you must agree to keep using a very reliable birth‑control method.

Who cannot join the trial?

5 criteria

If you had any serious side effects (called adverse events) from the study drug in the earlier trial that caused you to stop taking it, or if the doctor thinks the side effects would make it unsafe for you to keep using the drug.
If you developed a different type of psoriasis during the earlier trial, such as guttate psoriasis (small drop‑shaped spots), erythrodermic psoriasis (widespread red, inflamed skin), pustular psoriasis (pus‑filled blisters), or psoriasis caused by medication (drug‑induced psoriasis).
If you have any other serious illness or health problem (not psoriasis) now or in the past, or if a medical exam shows something that the doctor believes could put your safety at risk or affect the study results.
If recent lab tests (blood work, urine tests, etc.) show a significant abnormal result that the doctor thinks would make it unsafe for you to continue the study drug.
If you are currently pregnant or are breastfeeding a baby.

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Verified sites

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

Trial locations

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Investigated drugs

ORKA-001 is a medication given as an injection under the skin. In this study, it is being used to see how safe and well‑tolerated it is when taken for a long time by people who have moderate‑to‑severe plaque psoriasis. The trial will also look at how well the medicine works to improve the skin condition over many months.

What is already known about the treatment

ORKA-001 - ORKA-001 is given as a subcutaneous injection of a 600 mg solution for injection, meaning it is administered under the skin using a small needle. It is an experimental drug currently being studied in clinical trials for safety and effectiveness, and it is not yet approved for regular medical use. The medication is being tested to treat moderate-to-severe plaque psoriasis, a skin condition that causes thick, red patches. It works by blocking a specific protein in the immune system that drives inflammation, and it belongs to the class of biologic agents known as interleukin inhibitors.

Investigated diseases

Moderate-to-Severe Plaque Psoriasis - Plaque psoriasis is a skin condition that causes thick, red patches covered with silvery scales. In moderate-to-severe cases, these patches cover a large area of the body and may be itchy or painful. The disease often starts with small spots that gradually enlarge and merge into larger plaques. Over time, new plaques can appear, and existing ones may become thicker or more inflamed. Flare‑ups can be triggered by stress, injury to the skin, or certain infections, leading to periods of worsening symptoms. The condition tends to follow a chronic, relapsing‑remitting pattern.