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Study on the Effectiveness of LY4100511 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 known by its code name LY4100511 or DC-853. This medication works by inhibiting certain proteins called cytokines, specifically IL-17, which are involved in the inflammation process that contributes to psoriasis. The study will compare different doses of LY4100511 to see how effective they are in treating moderate-to-severe plaque psoriasis.

The purpose of the study is to evaluate the effectiveness of LY4100511 in reducing the symptoms of plaque psoriasis. Participants in the study will be randomly assigned to receive either the active medication or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for up to 12 weeks, during which participants will take the medication in tablet form by mouth. Throughout the study, participants will have regular check-ups to monitor their condition and any changes in their symptoms.

By the end of the study, researchers aim to determine how well LY4100511 works in improving the skin condition of those with moderate-to-severe plaque psoriasis. The study will also gather information on the safety of the medication and any side effects that may occur. This research is important for developing new treatments that can help manage plaque psoriasis more effectively.

1 randomization and baseline visit

Upon joining the study, participants undergo a baseline visit. This includes a clinical diagnosis of plaque psoriasis for at least six months prior to this visit.

Participants must have stable moderate to severe plaque psoriasis, defined as having at least 10% of the body surface area affected, a static Physician’s Global Assessment (sPGA) score of 3 or more, and a Psoriasis Area and Severity Index (PASI) score of 12 or more.

2 treatment initiation

Participants begin treatment with either the active medication LY4100511 or a placebo. The medication is administered orally in the form of tablets.

The dosage and frequency of administration are determined by the study protocol, which involves multiple dose regimens.

3 treatment duration

The treatment period lasts for 12 weeks. During this time, participants are required to take the medication as prescribed and attend scheduled visits for monitoring.

Participants must avoid prolonged exposure to the sun and refrain from using tanning booths, sun lamps, and other sources of ultraviolet light.

4 evaluation of treatment efficacy

The primary goal is to assess the proportion of participants achieving a 75% reduction in the PASI score at Week 12.

Secondary evaluations include achieving an sPGA score of 0 or 1 with at least a 2-grade improvement from baseline, and various levels of reduction in the PASI score at all scheduled timepoints.

5 safety monitoring

Safety data is collected throughout the study, including the number and proportion of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Participants are monitored for any discontinuations due to TEAEs.

6 plasma concentration measurement

Plasma concentration of LY4100511 is measured at scheduled timepoints to evaluate the steady state maximum concentration and trough concentration.

This helps in understanding the variability in how the medication is processed by different individuals.

Who Can Join the Study?

  • Must be between 18 and 70 years old at the time of signing the consent form.
  • Must have been diagnosed with plaque psoriasis for at least 6 months before the start of the study. Plaque psoriasis is a skin condition that causes red, scaly patches.
  • Must have moderate to severe plaque psoriasis, which means it affects at least 10% of the body, has a specific severity score (sPGA score of 3 or more), and another score (PASI score of 12 or more) at the start of the study.
  • Must be a candidate for light therapy (phototherapy) or treatments that affect the whole body (systemic therapy), as decided by the study doctor.
  • Must have a Body Mass Index (BMI) between 18 and 40. BMI is a measure of body fat based on height and weight.
  • People of any sex assigned at birth can participate, and they must follow local rules about using birth control during the study.
  • Must be able to give signed consent, agreeing to follow the study’s rules and requirements.
  • Must be able to swallow pills.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and complete tests and other study activities.
  • Must be willing to stop using any creams or treatments for psoriasis before starting the study medication.
  • Must agree to avoid spending too much time in the sun and not use tanning booths, sun lamps, or other sources of ultraviolet light during the study.

Who Cannot Join the Study?

  • Participants with any other skin conditions that might interfere with the study results.
  • Individuals who have used certain medications that could affect the study within a specific time frame before the trial.
  • People with a history of severe allergic reactions to any of the study medications.
  • Participants with any serious medical conditions that could make it unsafe for them to participate.
  • Women who are pregnant or breastfeeding.
  • Individuals who have participated in another clinical trial recently.
  • People who have a history of drug or alcohol abuse.
  • Participants who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Hautarztpraxis Dr. Mihaescu Augsburg Germany
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 Status
Pratia Prague s.r.o. Prague Czechia
MENSINGDERMAresearch GmbH Hamburg Germany
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
University Of Debrecen Debrecen Hungary
Clintrial s.r.o. Prague Czechia
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Pratia Pardubice a.s. Pardubice Czechia
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Synexus Polska Sp. z o.o. Poznan Poland
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Allergo-Derm Bakos Kft. Szolnok Hungary
Vital Medical Center Veszprem Hungary
Keypr avmnnrqsm Ffstozh szsszw Prague Czechia
Lhpbu Ctdufv Svnd dr Tadtfl Kcespqkdlux dj Aewoiak Kbhizzin Szczecin Poland
Uypksrtqkjcemoxcbynpj Maozhvbx Afj Munster Germany
Gfuezr Uunddsfkly Fgbngwvzd Frankfurt Germany
Plvaipi Sww z ooap Katowice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
15.11.2024
Germany Germany
Not recruiting
15.11.2024
Hungary Hungary
Not recruiting
15.11.2024
Poland Poland
Not recruiting
15.11.2024

Trial locations

Investigated drugs:

LY4100511 (DC-853) is an investigational medication being studied for its potential to treat moderate-to-severe plaque psoriasis in adults. This medication is being tested in different dose regimens to determine its effectiveness in reducing the symptoms of psoriasis, which is a skin condition characterized by red, scaly patches. The study aims to compare the effects of LY4100511 with a placebo to assess its potential benefits for patients suffering from this condition.

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 they 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 severity of plaque psoriasis can vary, with some individuals experiencing mild symptoms and others having more extensive and severe outbreaks. The condition tends to go through cycles, with periods of flare-ups followed by times of remission.

Trial ID:
2024-512207-39-00
Protocol code:
J5C-MC-FOAB
NCT ID:
NCT06602219
Trial Phase:
Therapeutic exploratory (Phase II)

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