Study on the Effectiveness and Safety of Vibozilimod 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 moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The treatment being tested is called SCD-044, which is taken in the form of tablets. The active ingredient in these tablets is vibozilimod, a type of medicine known as a selective immunosuppressive agent. This means it works by selectively reducing the activity of the immune system, which can help in managing the symptoms of psoriasis.

The purpose of this study is to determine how effective and safe SCD-044 is in treating moderate to severe plaque psoriasis. Participants in the study will be randomly assigned to receive either the SCD-044 tablets or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for up to 52 weeks, and participants will take the tablets orally. The main goal is to see if there is at least a 75% improvement in the severity and area of psoriasis after 16 weeks of treatment.

Throughout the study, participants will be monitored to assess the effectiveness of the treatment and to ensure their safety. The study aims to provide valuable information on whether SCD-044 can be a beneficial treatment option for those suffering from moderate to severe plaque psoriasis. This research could potentially lead to new ways to manage this challenging skin condition.

1 joining the study

Upon joining the study, the patient must provide written informed consent. This confirms understanding and agreement to participate in the study.

Eligibility is confirmed through a diagnosis of moderate to severe plaque psoriasis, with specific criteria such as body surface area involvement of at least 10%, a Psoriasis Area and Severity Index (PASI) score of 12 or more, and an Investigator’s Global Assessment (IGA) of at least moderate disease.

2 treatment phase

The patient will receive one of the following treatments: SCD-044 Tablets at doses of 0.1mg, 0.3mg, 0.6mg, or 1.0mg, or a placebo. The medication is taken orally.

The treatment is administered daily for a period of 16 weeks.

3 monitoring and assessment

Throughout the study, the patient’s condition is monitored to assess the effectiveness and safety of the treatment.

The primary goal is to determine if there is at least a 75% improvement in the PASI score by Week 16.

4 completion of the study

At the end of the 16-week treatment period, the patient’s progress is evaluated to determine the overall effectiveness of the treatment.

The study aims to conclude by July 21, 2025.

Who Can Join the Study?

Must be a male or a non-pregnant, non-breastfeeding female who is 18 years or older.
Must provide written consent to participate in the study before any study-related activities begin.
Must have been diagnosed with mainly plaque psoriasis for at least 6 months. This will be confirmed by talking to the patient and a physical check-up by the study doctor.
Must be someone who could be treated with light therapy (phototherapy) or medication that affects the whole body (systemic therapy) for plaque psoriasis. However, these treatments will not be allowed during the study.
Must have moderate to severe plaque psoriasis at the start of the study, which means:

Psoriasis covers at least 10% of the body surface area (BSA).
A Psoriasis Area and Severity Index (PASI) score of 12 or higher. PASI is a tool used to measure the severity and extent of psoriasis.
An Investigator’s Global Assessment (IGA) score of at least 3, indicating moderate disease. IGA is a scale used to assess the overall severity of psoriasis.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to similar treatments are excluded.
Patients with other skin conditions that might interfere with the study results are not eligible.
People with certain infections or diseases that affect the immune system cannot join the study.
Participants who have used similar treatments recently may be excluded.
Individuals with a history of drug or alcohol abuse might not be allowed to participate.
Patients with certain heart conditions or uncontrolled high blood pressure are excluded.
People who are currently participating in another clinical trial cannot join this study.
Individuals with a history of cancer, except for some types of skin cancer, may be excluded.
Patients who have had major surgery recently might not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Specjalistyczne Gabinety Lekarskie Landa	Cracow	Poland

Other Sites

Site Name	City	Country
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.	Cracow	Poland
Appletreeclinics Network Sp. z o.o.	Lodz	Poland
Kliiniliste Uuringute Keskus OÜ	Tartu	Estonia
Synexus Polska Sp. z o.o.	Poznan	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
North Estonia Medical Centre Foundation	Tallin	Estonia
Gzzgf Bpmtaut Kcsluwlqu Sek z ougs	Klodzko	Poland
Pmmqrpafrtx Ehjjyutbjame	Wroclaw	Poland
Puwpepcmq Iupqrwcy Mhajvxza Mriflznushrh Slmmv Wzkkxffypmeu I Agwdoofspzvhh	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Estonia	Not recruiting	09.01.2024
Poland	Not recruiting	09.01.2024

Trial locations

Investigated drugs:

Vibozilimod

SCD-044 is a medication being studied for its potential to treat moderate to severe plaque psoriasis. The goal of the trial is to see how effective SCD-044 is in improving the condition of the skin in patients with this type of psoriasis. Researchers are looking to see if patients experience at least a 75% improvement in their psoriasis symptoms after 16 weeks of treatment with SCD-044.

Moderate to Severe Plaque Psoriasis – This is a chronic skin condition characterized by the development of thick, red patches covered with silvery-white scales. These patches, known as plaques, can appear anywhere on the body but are most commonly found on the elbows, knees, scalp, and lower back. The disease progresses through cycles, with periods of flare-ups followed by times of remission. During flare-ups, the plaques can become itchy, painful, and may crack or bleed. The severity of the condition can vary, with moderate to severe cases involving larger areas of the body and more intense symptoms. The exact cause is not fully understood, but it is believed to involve an immune system dysfunction that accelerates the growth cycle of skin cells.

Trial ID:

2023-506477-35-00

Protocol code:

SCD-044-19-14

NCT ID:

NCT04566666

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Vibozilimod for Adults with Moderate to Severe Plaque Psoriasis

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