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Study Comparing CT-P55 and Secukinumab for Moderate to Severe Plaque Psoriasis Patients

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What is this trial about?

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

This clinical trial is focused on studying a skin condition called plaque psoriasis, which is characterized by red, scaly patches on the skin. The study will compare two treatments: CT-P55 and Cosentyx. Both treatments contain the active substance secukinumab, which is a type of protein designed to help reduce inflammation and improve the symptoms of psoriasis.

The purpose of the study is to determine if CT-P55 is as effective and safe as Cosentyx for treating moderate to severe plaque psoriasis. Participants in the study will receive either CT-P55 or Cosentyx through injections under the skin. The study will last for several weeks, during which the effects of the treatments will be closely monitored.

Throughout the study, participants will have regular check-ups to assess the changes in their psoriasis symptoms. The main goal is to see how much the psoriasis improves by measuring the change in the Psoriasis Area and Severity Index (PASI) score after eight weeks of treatment. This will help researchers understand if CT-P55 can be a reliable alternative to Cosentyx for people with plaque psoriasis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial administration
The study begins with the first administration of the study drug. The drug used is either Cosentyx or CT-P55, both of which are solutions for injection.
The medication is administered through a subcutaneous injection, which means it is injected under the skin.
The initial administration marks the start of the treatment phase for patients with moderate to severe plaque psoriasis.
Step 2
Treatment phase
During the treatment phase, the medication is administered regularly. The specific dosage and frequency are determined by the study protocol.
The primary goal during this phase is to observe the percent change from baseline in the Psoriasis Area and Severity Index (PASI) score at Week 8.
Patients continue to receive the medication through subcutaneous injections throughout this phase.
Step 3
Evaluation at week 8
At Week 8, an evaluation is conducted to assess the efficacy of the treatment.
The main objective is to determine if CT-P55 is equivalent to Cosentyx in terms of efficacy, based on the change in PASI score.
This evaluation helps in understanding the effectiveness of the treatment in reducing the severity of plaque psoriasis.
Step 4
Continuation and monitoring
After the initial evaluation, the treatment continues as per the study protocol.
Patients are monitored regularly to ensure safety and to observe any changes in their condition.
The study is expected to continue until the estimated end date in August 2026, with ongoing assessments and monitoring.

Who can join the trial?

7 criteria

The patient must be a male or female between the ages of 18 and 75 years old.
The patient must weigh less than 110 kg.
The patient must have been diagnosed with **chronic plaque psoriasis** for at least 24 weeks before starting the study medication. **Chronic plaque psoriasis** is a long-lasting skin condition that causes red, scaly patches on the skin.
The patient must have stable moderate to severe **psoriasis** with or without **psoriatic arthritis** at both the screening and the start of the study medication. **Psoriasis** is a skin condition, and **psoriatic arthritis** is a type of arthritis that affects some people with psoriasis.
The patient must have a **PASI score** of 12 or greater. The **Psoriasis Area and Severity Index (PASI)** is a tool used to measure the severity and extent of psoriasis.
The patient must have an **Investigator’s Global Assessment (IGA) score** of 3 or greater. This score is based on a scale from 0 to 4, where higher numbers indicate more severe psoriasis.
The patient must have **plaque psoriasis** affecting 10% or more of their **Body Surface Area (BSA)**. **Body Surface Area (BSA)** is a way to measure the total area of the human body that is affected by psoriasis.

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar medications are excluded.
Patients with other skin conditions that might interfere with the study results cannot join.
Patients who have used certain medications recently that could affect the study results are not allowed.
Patients with serious infections or a weakened immune system are excluded.
Patients with a history of cancer, except for certain types of skin cancer, cannot participate.
Patients with liver or kidney problems that are not well controlled are excluded.
Patients who have participated in another clinical trial recently are not allowed.
Patients with a history of drug or alcohol abuse are excluded.
Patients with certain heart conditions that are not well controlled cannot join.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Verified
Clinicmed Daniluk Nowak Sp. k.
Bialystok, Poland
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

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Investigated drugs

CT-P55
is a medication being tested in this clinical trial. It is designed to treat patients with moderate to severe plaque psoriasis. The goal of the trial is to see if CT-P55 works as well as another medication called Cosentyx in reducing the symptoms of psoriasis, such as redness, thickness, and scaling of the skin.
Cosentyx
is an already approved medication used to treat moderate to severe plaque psoriasis. It works by targeting specific proteins in the immune system that contribute to the symptoms of psoriasis. In this trial, Cosentyx is used as a comparison to evaluate the effectiveness of CT-P55.

Secukinumab

What is already known about the treatment

CT-P55
CT-P55 is administered via injection and is currently being studied in clinical trials for its effectiveness in treating moderate to severe plaque psoriasis. It is being compared to Cosentyx, a well-established medication for this condition. The main therapeutic indication for CT-P55 is to reduce the symptoms of plaque psoriasis, which includes scaling, redness, and inflammation of the skin. At the molecular level, CT-P55 works by targeting specific proteins in the immune system that contribute to the inflammatory process in psoriasis. It is classified pharmacologically as a biologic agent, specifically a monoclonal antibody.
Cosentyx
Cosentyx is administered through injection and is an approved medication widely used for treating moderate to severe plaque psoriasis. It is recognized in medical literature for its effectiveness in reducing the symptoms of this skin condition. The primary therapeutic indication for Cosentyx is to alleviate the symptoms associated with plaque psoriasis, such as scaling and inflammation. Its mechanism of action involves inhibiting a specific protein in the immune system, known as interleukin-17A, which plays a key role in the inflammatory process of psoriasis. Cosentyx is classified as a biologic agent, specifically a monoclonal antibody.

Investigated diseases

Plaque Psoriasis – Plaque psoriasis is a chronic skin condition characterized by the development of thick, red patches covered with silvery-white scales. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The condition results from an overactive immune system that speeds up the growth cycle of skin cells. As new skin cells form too quickly, they accumulate on the surface, leading to the formation of plaques. The affected areas can be itchy, painful, and may crack or bleed. The severity of plaque psoriasis can vary, with some individuals experiencing only minor irritation, while others may have widespread, severe symptoms.