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Testing IDOR-1117-2520 for Adults with Moderate to Severe Chronic Plaque Psoriasis With or Without Psoriatic Arthritis

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What is this trial about?

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

This study involves people with moderate to severe chronic plaque psoriasis, a condition where the skin develops raised, red, scaly patches that can be itchy and painful. Some people in this study may also have psoriatic arthritis, which is joint inflammation that can occur along with psoriasis. The study will test a medication called IDOR-1117-2520, which is given as a gastro-resistant tablet (a type of tablet that does not break down in the stomach but passes through to the intestines). Some participants will receive the actual medication while others will receive a matching placebo.

The purpose of this study is to explore how well IDOR-1117-2520 works compared to placebo in improving the skin condition of people with moderate to severe chronic plaque psoriasis, and to check if the medication is safe. The study will look at changes in a measurement called the Psoriasis Area and Severity Index, which is a way doctors score how much of the body is affected by psoriasis and how severe the patches are. The study will also examine whether the overall appearance of the skin improves as assessed by doctors, and will monitor for any unwanted effects or side effects that may occur during treatment.

The study will last for twelve weeks of treatment, during which participants will take the medication or placebo by mouth. Throughout the study, participants will have regular check-ups where doctors will examine their skin, measure vital signs like blood pressure and heart rate, check body weight, take blood samples for laboratory tests, and perform electrocardiogram tests (a test that records the electrical activity of the heart). Participants who are able to become pregnant will need to have pregnancy tests and use reliable birth control methods during the study and for thirty days after stopping the medication.

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
Screening and baseline assessment
At the beginning of the study, your condition will be assessed to confirm eligibility. This includes evaluation of your plaque psoriasis, which is a skin condition causing red, scaly patches on the skin.
Your Psoriasis Area and Severity Index score will be measured. This is a scoring system that assesses how much of your body is affected by psoriasis and how severe it is.
A static physician's global assessment score will be recorded. This is an overall rating by the doctor of how severe your psoriasis appears.
If you are able to become pregnant, a pregnancy test will be performed, and you will need to agree to use highly effective contraception throughout the study and for 30 days after stopping the study medication.
Step 2
Randomization and treatment start
You will be randomly assigned to receive either IDOR-1117-2520 or a placebo. A placebo is an inactive substance that looks identical to the actual medication but contains no active ingredient.
The study medication will be provided as gastro-resistant tablets, which are designed to pass through the stomach and dissolve in the intestines.
You will take the medication by mouth.
Neither you nor your doctor will know which treatment you are receiving during the study.
Step 3
Treatment period
You will continue taking the assigned medication for twelve weeks.
During this period, your psoriasis will be regularly assessed using the Psoriasis Area and Severity Index and static physician's global assessment scores.
Regular monitoring visits will occur to evaluate how your skin condition is responding to the treatment.
Step 4
Safety monitoring throughout the study
Throughout the treatment period, your safety will be monitored at regular intervals.
Your vital signs will be measured, including blood pressure, heart rate, and temperature.
Your body weight will be recorded.
Blood and other laboratory tests will be performed to check how your body is responding to the medication.
An electrocardiogram will be performed. This is a test that records the electrical activity of your heart.
If you are able to become pregnant, monthly urine pregnancy tests will be conducted.
Any side effects or health problems you experience will be recorded and assessed.
Step 5
Week 12 assessment
At week 12, a comprehensive assessment will be performed to measure the change in your psoriasis from the start of the study.
This will include measurement of your Psoriasis Area and Severity Index score to determine if there has been improvement in your condition.
Your static physician's global assessment score will also be evaluated to see if your psoriasis has become clear or almost clear.
Step 6
Follow-up period
After completing the twelve-week treatment period, you will enter a follow-up phase that continues until week 16.
During this time, additional assessments will be performed to monitor your condition and any ongoing effects.
Safety monitoring will continue, including checks of vital signs, laboratory tests, and recording of any side effects.
If you are able to become pregnant, you will need to continue using contraception for 30 days after stopping the study medication.

Who can join the trial?

11 criteria

You must have moderate to severe chronic plaque psoriasis that has been stable for at least 6 months before joining the study. Plaque psoriasis is a skin condition that causes thick, scaly patches on the skin. Moderate to severe means the condition covers a significant area of your body and causes noticeable symptoms.
You may have psoriatic arthritis along with your psoriasis, or you may have psoriasis alone. Psoriatic arthritis is joint inflammation that can occur in some people with psoriasis.
Your PASI score must be 12 or higher. PASI is a measurement system doctors use to assess how severe your psoriasis is by looking at redness, thickness, and scaling of the skin patches, as well as the area affected.
Your sPGA score must be 3 or higher. This is a rating system where your doctor evaluates the overall severity of your psoriasis at a single point in time.
At least 10 percent of your body surface area must be affected by psoriasis. This means psoriasis covers at least one-tenth of your total skin.
These scores and measurements must meet the required levels at two different times: at the initial screening visit and at the time you would start the study treatment.
Your doctor must determine that you are a suitable candidate for systemic therapy for your psoriasis. Systemic therapy means treatments that work throughout your entire body, such as pills, injections, or light therapy, rather than creams applied only to the skin.
If you are able to become pregnant, you must have a negative pregnancy test at the screening visit and again before starting the study treatment.
If you are able to become pregnant, you must agree to use a highly effective method of contraception from the screening visit until 30 days after you stop taking the study treatment. Highly effective contraception means birth control methods that are very reliable at preventing pregnancy.
If you are able to become pregnant, you must agree to remain sexually inactive, or have a partner who has had a vasectomy. A vasectomy is a surgical procedure that prevents a man from being able to cause pregnancy.
If you are able to become pregnant, you must agree to take monthly urine pregnancy tests during the study and for at least 30 days after stopping the study treatment.

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria for this clinical trial
Exclusion criteria are the reasons why someone cannot participate in a study, but this information was not included in the available trial details
To learn about specific reasons that would prevent participation in this study, you would need to access the complete trial documentation

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Spitalul Clinic Judetean De Urgenta Cluj
Cluj Napoca, Romania

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Investigated drugs

IDOR-1117-2520 is an investigational medication being tested in this study. It is being evaluated to see if it can help reduce the symptoms of moderate to severe chronic plaque psoriasis, which is a skin condition that causes red, scaly patches on the skin. The medication is also being studied in people who may have psoriatic arthritis along with their psoriasis. This is an experimental treatment, which means it is still being tested to determine if it works and if it is safe for patients with these conditions.

IDOR-1117-2520C

What is already known about the treatment

IDOR-1117-2520 – This is an investigational medication currently being studied in clinical trials for the treatment of moderate to severe chronic plaque psoriasis, a long-lasting skin condition that causes red, scaly patches on the skin. The drug is being tested in a twelve-week trial to compare its effectiveness against a placebo (inactive treatment) in reducing the severity and extent of psoriasis symptoms. While the specific form of administration and exact mechanism of action are not detailed in the available information, the medication is designed to target the underlying processes that cause psoriasis at the molecular level. At this stage, IDOR-1117-2520 is not yet approved for general medical use and is still in the proof-of-concept phase of research to determine if it can safely and effectively help patients with this chronic skin disorder.

Investigated diseases

Chronic Plaque Psoriasis – Chronic plaque psoriasis is a long-lasting skin condition that causes red, raised patches covered with silvery-white scales to develop on the skin. These patches, called plaques, most commonly appear on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The affected skin may be itchy, painful, or cause discomfort. This condition occurs when the immune system mistakenly speeds up the growth cycle of skin cells, causing them to build up rapidly on the surface. Psoriasis is a chronic disease, meaning it persists over time with periods when symptoms worsen and periods when they improve. The severity can range from a few small patches to extensive areas of affected skin covering large portions of the body.