Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants with Moderate-to-Severe Plaque Psoriasis

This research study is looking into a new medication called LY4100511 for people aged 18 and over who have moderate to severe plaque psoriasis. It's a Phase 2 trial, which means it's an early step to find out if the new medicine is both safe and effective in treating the condition, and to help decide on the best dose. Participants will either receive the new medicine or a 'dummy' pill (placebo) that looks exactly the same, but contains no active drug. This is done to help researchers compare the effects accurately. The main goal is to see how many participants achieve a significant improvement in their psoriasis after 12 weeks. Researchers will also look at other improvements, side effects, and how the body handles the medicine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Dice Therapeutics Inc.

Enrolment target

134

Start

23 Jan 2025

Plaque Psoriasis

What is this study about?

Plaque psoriasis is a common skin condition that causes red, flaky, crusty patches covered with silvery scales. These patches can be itchy, painful, and sometimes crack and bleed. In this study, doctors are investigating a new medicine, LY4100511, which could offer a new way to treat moderate to severe plaque psoriasis. This is a "Phase 2" trial, which means it's an important early stage of testing. They want to find out if the medicine works well enough to consider it for wider use, and to check for any side effects.

To do this fairly, the study is designed so that some people will receive the new medicine, while others will receive an inactive 'dummy' pill, called a placebo. Neither the patients nor their doctors will know who is getting which, until the study is over. This helps ensure that any improvements or side effects seen are genuinely due to the medicine and not other factors, like knowing you're receiving a new treatment. All the dummy pills will look exactly like the active medicine.

The main thing the researchers want to find out is how many people experience a significant improvement in their psoriasis after 12 weeks, as measured by a special scoring system. They will also look at how much the psoriasis clears up in different ways, how overall skin health changes, and if the medicine causes any unwanted effects. This information is crucial for understanding if LY4100511 could be a helpful new treatment option for people living with plaque psoriasis.

Key takeaways

This study is for adults with moderate to severe plaque psoriasis.
It's testing a new medicine (LY4100511) against a dummy pill (placebo).
It's a Phase 2 trial, focusing on effectiveness and safety.
Participation involves regular clinic visits and taking daily tablets.
The main goal is to see how much psoriasis improves after 12 weeks.

Who may be eligible?

This study is looking for adults who are at least 18 years old. People of any gender can take part.

To be considered for this study, you would need to have been diagnosed with moderate to severe plaque psoriasis. This means your psoriasis affects a noticeable area of your skin and is significant enough to require treatment.

There might be other specific health requirements or conditions that would mean you can or cannot join the study. This is to make sure the study is safe for everyone involved and that the results are as clear as possible.

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.

Are you 18 years old or older?
Do you have a diagnosis of moderate to severe plaque psoriasis?
Are you willing to take daily tablets as part of the study?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic. You'll receive either the new medicine (LY4100511) or a dummy pill that looks identical, and you won't know which one you're getting. You'll take these tablets as instructed. During your visits, doctors and nurses will assess your psoriasis using a scoring system, measure the area of skin affected, and ask about any new symptoms or side effects you might be experiencing. You will also have blood tests at certain times to measure the amount of the study medicine in your body. The study will last for a specific period, with the main assessment for how well the treatment works happening at Week 12, but you will likely have follow-up visits after this. The total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer some potential benefits, such as receiving a new medicine before it's widely available, and close monitoring of your health by a medical team. However, there are also potential risks. The new medicine might cause side effects, which could be mild or more serious, and it might not work for everyone. Because some participants receive a dummy pill, there's a chance you might not get the active treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Poland
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Unverified
Czechia
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Unverified
Germany

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common skin condition where patches of skin become red, flaky, and scaly, often feeling itchy or sore.

What does 'Phase 2' mean for a study?

Phase 2 is an early stage of testing a new medicine. It aims to see if the medicine works, at what dose, and to learn more about its safety.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine accurately.

Will I know if I'm getting the new medicine or the placebo?

No, neither you nor your doctor will know during the study. This ensures the results are fair and unbiased.

How long will I be in the study?

The main part of the study involves assessments up to Week 12, but your total participation might be longer with follow-up visits. The study team will tell you the exact length.