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

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy M. Brzewski, P. Brzewski S.C.	Cracow	Poland
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
NZOZ LECZNICA MAK-MED s.c.	Nadarzyn	Poland
Royalderm Agnieszka Nawrocka	Warsaw	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Wromedica I Bielicka A Strzalkowska s.c.	Wroclaw	Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Cwryscl Blxlf Kehthlgtbax Pcoapqcf Svb z otap	Gdansk	Poland
Drlavzvrqd Siz z oghe	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.04.2025

Trial locations

Investigated drugs:

Secukinumab

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.

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.

Trial ID:

2024-513348-27-00

Protocol code:

CT-P55 3.1

NCT ID:

NCT06630559

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?