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Study of early versus late risankizumab treatment to evaluate immune cell response in patients with moderate to severe psoriasis

InvestigationalNo placebo

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What is this trial about?

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

This study focuses on patients with moderate-to-severe psoriasis, a skin condition that causes red, scaly patches on the skin. The research examines the effects of risankizumab, a medication given as an injection under the skin, in treating this condition. The study specifically looks at how the timing of treatment affects the results - comparing patients who start treatment early (within one year of first symptoms) versus those who have had psoriasis for more than ten years.

The medication being studied, Skyrizi (risankizumab), is administered as a solution for injection. Participants receive injections containing 150 mg of the medication. The study aims to determine if early treatment with risankizumab is more effective at targeting specific immune cells in the skin compared to treatment started later in the disease course.

The study lasts for approximately one year, during which participants receive regular injections and undergo skin evaluations. The treatment schedule follows standard dosing guidelines, with participants receiving injections at specific intervals throughout the study period. The total amount of medication received during the study does not exceed 700 mg.

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 treatment phase
You will receive Skyrizi (risankizumab) through subcutaneous injection (under the skin).
The treatment follows the standard dosing schedule for moderate to severe psoriasis.
Your first dose will be administered at the beginning of the study (week 0).
Step 2
Early evaluation period
At week 4, your skin condition will be evaluated using the PASI score (a measure of psoriasis severity).
A skin examination will be performed to assess your response to the treatment.
Step 3
First major assessment
At week 16, you will undergo a comprehensive evaluation.
This includes a skin examination and measurement of your PASI score.
A small skin sample (biopsy) will be taken to measure specific cells related to psoriasis.
Step 4
Continued treatment phase
Additional evaluations will occur at weeks 28 and 40.
Your skin condition will continue to be monitored using the PASI score.
The treatment with Skyrizi will continue according to the standard schedule.
Step 5
Final major assessment
At week 52, you will have the final major evaluation.
This includes a skin examination, PASI score measurement, and another small skin sample.
Blood tests will be performed to measure inflammation markers.
Step 6
Safety follow-up
The final safety assessment will occur at week 60.
This visit will complete your participation in the study.

Who can join the trial?

13 criteria

Must sign an informed consent document and agree to follow study requirements
Must be 18 years or older when signing the consent form
Must have plaque psoriasis with at least one of these conditions:
- PASI score of 5 or higher (a measure of psoriasis severity)
- sPGA score of 3 or higher (doctor's assessment of severity)
- More than 10% of body surface affected
- Must belong to one of these groups:
  - Early Treatment Group: First psoriasis symptoms appeared within last 12 months and no previous systemic treatments
  - Late Treatment Group: Psoriasis present for more than 10 years with no previous biologic or advanced oral therapy
  - For female participants: must be either post-menopausal or using approved birth control methods
  - Must have acceptable laboratory test results including:
    
    Liver function tests within normal ranges
    Adequate blood cell counts
    Normal kidney function
    Acceptable triglyceride levels
    Must be able to attend all scheduled study visits and follow study procedures

Who cannot join the trial?

15 criteria

History of treatment with risankizumab (a medication used to treat psoriasis)
Current pregnancy or breastfeeding
Active or chronic infection, including tuberculosis
History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
Significant heart problems or uncontrolled high blood pressure
Severe liver disease or abnormal liver function tests
Previous allergic reactions to similar medications
Current participation in other clinical trials
Use of other biological treatments for psoriasis in the past 3 months
Major surgery planned during the study period
Severe mental health conditions that could interfere with study participation
Drug or alcohol abuse within the past year
Any condition that, in the investigator's opinion, could make participation unsafe
Unable or unwilling to follow study procedures
Living outside the designated study area

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Investigated drugs

Risankizumab is a medication used to treat moderate to severe psoriasis. It works by targeting specific proteins in the immune system that cause inflammation in the skin. This medication helps reduce the symptoms of psoriasis, such as red, scaly patches on the skin. It is given as an injection under the skin and works by affecting memory T cells, which are part of the body's immune system that contribute to psoriasis development.

Risankizumab

What is already known about the treatment

Risankizumab - A biologic medication administered through subcutaneous injection that belongs to the class of interleukin-23 (IL-23) inhibitors used primarily for treating moderate to severe plaque psoriasis. The drug works by selectively targeting and blocking IL-23, a key protein involved in the inflammatory process that leads to psoriasis, thereby reducing skin inflammation and improving symptoms. This monoclonal antibody has demonstrated significant efficacy in clinical trials for achieving clear or almost clear skin in psoriasis patients, with the treatment typically administered as an injection under the skin at scheduled intervals determined by a healthcare provider.

Investigated diseases

Psoriasis - A chronic autoimmune skin condition that causes cells to build up rapidly on the surface of the skin. This accelerated skin cell growth results in thick, scaly patches that can be red, itchy, and sometimes painful. These patches, known as plaques, most commonly appear on the knees, elbows, trunk, and scalp. The condition typically goes through cycles, with periods of flare-ups alternating with periods of remission. The severity can vary from small, localized patches to complete body coverage.