A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P55 with Cosentyx in Patients with Moderate to Severe Plaque Psoriasis
Plaque psoriasis is a long-lasting skin condition that causes raised, red, scaly patches that can feel sore or itchy. Cosentyx is an approved injection that helps clear these skin patches by targeting inflammation. This trial compares Cosentyx with a new medicine called CT-P55. CT-P55 is developed as a 'biosimilar', meaning it is designed to work in the exact same way as Cosentyx. Biosimilar medicines help provide more treatment choices and can make valuable therapies more affordable for health services like the NHS. The main goal of this study is to measure how much patients' skin clears after eight weeks of treatment. Adults aged 18 and over with moderate to severe plaque psoriasis can take part. Everyone receives active medicine, and doctors will carefully monitor all participants throughout the study.
At a glance
What is this study about?
Plaque psoriasis happens when the body's immune system causes skin cells to build up too quickly, leading to thick, scaly patches called plaques. For people with moderate to severe psoriasis, everyday creams may not be enough. In these cases, doctors often use targeted biological medicines given by injection, such as Cosentyx, to help control the immune response and clear the skin.
This study is testing a new medicine known as CT-P55. CT-P55 is designed to be a biosimilar version of Cosentyx. A biosimilar is a highly similar copy of an already approved biological treatment. It works through the same biological pathway and aims to provide the same health benefits and safety profile as the original drug.
During this trial, researchers want to see if CT-P55 improves skin plaques just as well as Cosentyx does. To measure this, doctors will use a standard scoring tool called the PASI score, which measures how much of the skin is affected and how red or thick the patches are. The primary check happens at eight weeks to see the percentage improvement in patients' skin.
Trials like this are important because approved biosimilars give doctors and patients more treatment options. They also help lower healthcare costs, allowing services like the NHS to treat more people living with severe skin conditions.
Key takeaways
- The trial compares a new biosimilar medicine (CT-P55) with an approved treatment (Cosentyx).
- It is aimed at adults aged 18 and older who have moderate to severe plaque psoriasis.
- All participants receive an active injection medicine; no dummy drug (placebo) is used.
- Skin improvement is carefully checked at week 8 using a standard medical score.
- Taking part is voluntary, with regular health checks provided by a specialist team.
Who may be eligible?
This study is open to men and women aged 18 and over who have been diagnosed with moderate to severe plaque psoriasis. This generally means the psoriasis covers a significant area of skin or causes noticeable redness, scaling, and thickness that affects daily life.
You may not be able to join if you have other severe medical conditions, such as active infections, or a history of serious allergic reactions to biologic injections. Women who are pregnant or planning to become pregnant during the trial may also be excluded for safety reasons.
A study doctor will carry out a detailed health check, including reviewing your medical history and examining your skin, to confirm whether taking part is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with moderate to severe plaque psoriasis.
- My psoriasis covers a noticeable area of my body or causes significant symptoms.
- I do not have an active, serious infection.
- I am able and willing to attend regular clinic appointments and receive injections.
What does participation involve?
If you decide to take part, you will be randomly placed into one of two groups. One group will receive CT-P55, and the other will receive Cosentyx. This is a double-blind trial, which means neither you nor your study doctor will know which of the two medicines you are receiving until the trial is finished. Both treatments are active medicines; there is no dummy drug (placebo).
The medicine is given as a liquid injection just under the skin using a pre-filled syringe. You will need to attend regular clinic appointments for health checks, blood tests, and skin assessments so the team can track your progress. The main assessment of your skin happens at week 8, but your overall involvement will last longer to monitor your health and safety. The study team will provide a clear calendar of all clinic visits before you begin.
Potential risks and benefits
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Common questions
What is a biosimilar medicine?
A biosimilar is a biological medicine designed to be essentially the same as an existing approved biological drug. It works the same way and offers comparable safety and effectiveness.
Will I receive a placebo (dummy medicine)?
No. This study compares two active treatments directly. You will receive either the approved medicine Cosentyx or the study medicine CT-P55.
How is the treatment given?
The medicine is given as an injection under the skin using a pre-filled syringe, similar to how many standard psoriasis treatments are given.
Do I have to pay to take part in this trial?
No, all trial medicines, clinic visits, and study-related tests are provided free of charge, and travel expenses may be covered.
Can I leave the study if I change my mind?
Yes, taking part is completely voluntary. You are free to leave at any time without giving a reason and without affecting your standard medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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