Study on the Effectiveness and Safety of DC-806 for Adults with Moderate to Severe Plaque Psoriasis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The treatment being tested is a medication called DC-806, which is taken as a film-coated tablet. The purpose of the study is to evaluate how well DC-806 works and how safe it is for people with moderate to severe plaque psoriasis.

Participants in the study will be randomly assigned to receive either the DC-806 tablets or a placebo. The study will last for a period of 12 weeks, during which participants will take the medication orally. Throughout the study, researchers will monitor the participants to assess the effectiveness of the treatment and any potential side effects. The goal is to determine if DC-806 can significantly reduce the symptoms of plaque psoriasis compared to the placebo.

By the end of the study, researchers hope to gather enough information to understand the potential benefits and risks of using DC-806 for treating plaque psoriasis. This information will help in deciding whether DC-806 could be a viable treatment option for individuals suffering from this condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria, such as age, body mass index, and the severity of your plaque psoriasis.

You will be asked to discontinue any current topical or systemic therapies for psoriasis before starting the study medication.

2 randomization

You will be randomly assigned to receive either the study medication, DC-806, or a placebo. A placebo is a tablet that looks like the study medication but does not contain the active ingredient.

This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

3 medication administration

You will take the assigned tablets orally. The dosage and frequency will be determined by the study protocol, which will be explained to you during the trial.

The duration of the medication administration phase is specified in the study protocol, and you will be informed of the exact timeframe.

4 regular check-ups

Throughout the study, you will attend regular check-up visits. These visits are scheduled to monitor your health and the effects of the medication.

During these visits, various assessments will be conducted, including measuring the severity of your psoriasis and checking for any side effects.

5 final evaluation

At the end of the study period, a final evaluation will be conducted. This will include a comprehensive assessment of your psoriasis and overall health.

The results of the study will be analyzed to determine the efficacy and safety of DC-806 compared to the placebo.

Who Can Join the Study?

Must be a male or female between 18 to 70 years old.
Must have a Body Mass Index (BMI) between 18 to 40 kg/m². BMI is a measure of body fat based on height and weight.
Must have a clinical diagnosis of plaque psoriasis for at least 6 months before the start of the study.
Must have moderate to severe chronic plaque psoriasis, which means:

Psoriasis covers at least 10% of the body surface area (BSA).
A static Physician’s Global Assessment (sPGA) score of at least 3. This is a scale used to measure the severity of psoriasis.
A Psoriasis Area and Severity Index (PASI) score of at least 12. This is another scale used to measure the severity and extent of psoriasis.

Must be a candidate for phototherapy (light treatment) or systemic therapy (treatment affecting the entire body), as determined by the study doctor.
Women of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 30 days after the last dose of the study drug.
Must be willing to stop using topical and/or systemic therapies for psoriasis before starting the study drug.

Who Cannot Join the Study?

Patients with any other skin conditions that might interfere with the study results.
Patients who have had a recent infection or are currently experiencing an infection.
Patients who have a history of severe allergic reactions.
Patients who are currently using other treatments for psoriasis that might interfere with the study.
Patients who have participated in another clinical trial recently.
Patients who are pregnant or breastfeeding.
Patients with a history of certain heart conditions.
Patients with a history of certain liver or kidney problems.
Patients who have a history of cancer, except for some types of skin cancer.
Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Semmelweis University	Budapest	Hungary
Pratia Prague s.r.o.	Prague	Czechia
Clintrial s.r.o.	Prague	Czechia
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Wromedica I Bielicka A Strzalkowska s.c.	Wroclaw	Poland
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
ISA Interdisciplinary Study Association GmbH	Berlin	Germany
Allergo-Derm Bakos Kft.	Szolnok	Hungary
Vital Medical Center	Veszprem	Hungary
Pqxilxe Sav z oyaf	Katowice	Poland
Gpffto Uxendhcehk Farlhfcox	Frankfurt	Germany
Hhdqtvan Dh Lr Sgfxr Ckyp I Sdlb Pzv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.09.2023
Germany	Not recruiting	01.09.2023
Hungary	Not recruiting	01.09.2023
Poland	Not recruiting	01.09.2023
Spain	Not recruiting	01.09.2023

Trial locations

Investigated drugs:

Dc-806

DC-806 is a medication being studied for its potential to help people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. This medication is being tested to see if it can reduce the symptoms of psoriasis, such as the redness and scaling, and improve the overall condition of the skin. The study is also looking at how safe the medication is for people to use and whether it causes any side effects. Participants in the trial are given different amounts of the medication to find out which amount works best and is safest.

Investigated diseases:

Psoriasis

Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition characterized by the rapid growth of skin cells, leading to the formation of thick, red, scaly patches on the skin. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The disease progresses through cycles, with periods of increased activity (flare-ups) followed by times of remission. During flare-ups, the plaques can become itchy, painful, and may crack or bleed. The severity of plaque psoriasis can vary, with some individuals experiencing only minor patches, while others have widespread, severe plaques. The exact cause of plaque psoriasis is not fully understood, but it involves an overactive immune response that accelerates the growth cycle of skin cells.

Trial ID:

2022-502249-90-00

Protocol code:

DCE806201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of DC-806 for Adults with Moderate to Severe Plaque Psoriasis

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