Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Multicenter, Randomized, Double-blind, Placebo- controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of DC-806 in Participants with Moderate to Severe Plaque Psoriasis

This research study is testing a new tablet medicine, DC-806, for adults who have moderate to severe plaque psoriasis. The main goal is to find out how effective this new medicine is at improving skin symptoms compared to a placebo (a tablet with no active medicine). Researchers will also be checking carefully for any side effects to understand its safety. Different doses of DC-806 will be tried. This is an important step to see if DC-806 could become a new treatment option for psoriasis, helping people achieve clearer skin and better manage their condition. Participants will be monitored closely throughout the study.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

DICE Therapeutics Inc.

Enrolment target

206

Start

17 Aug 2023

Plaque Psoriasis

What is this study about?

This study is looking into a new tablet medicine called DC-806 for people living with moderate to severe plaque psoriasis. Psoriasis is a long-lasting skin condition that causes red, flaky patches covered with silvery scales. The researchers want to find out how well DC-806 works to clear up these skin patches and how safe it is to use. This kind of study helps us understand if new medicines are helpful for patients.

To make sure the results are fair and accurate, some people in the study will receive DC-806, while others will get a 'placebo'. A placebo looks exactly like the study medicine but doesn't contain any active ingredients – it's like a dummy pill. Neither the patients nor their doctors will know who is getting what until the study is over. This helps stop anyone's expectations from affecting the results.

The study will also test different amounts (doses) of DC-806 to see which dose works best and is safest. By carefully comparing the new medicine to a placebo, doctors can learn if DC-806 could be a good new medicine to help people manage their psoriasis and improve their quality of life.

Key takeaways

This study is testing a new tablet medicine (DC-806) for moderate to severe plaque psoriasis.
It's a 'blinded' study, meaning some people get the new medicine, and others get a dummy pill (placebo).
The main goals are to see how well the medicine clears skin and if it's safe.
Different doses of DC-806 are being tested to find the best amount.
The study involves regular clinic visits and careful monitoring over about 12 weeks.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or over. The study is open to both men and women.

You would generally be considered if you have plaque psoriasis that is moderate to severe. This means your psoriasis affects a significant part of your body and/or has a big impact on your daily life.

Other specific medical criteria would also need to be met to ensure the study is safe and appropriate for you, and to make sure the results are reliable. Your doctor will discuss these with you in detail.

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 plaque psoriasis?
Is your psoriasis considered moderate to severe by your doctor?
Are you able to attend regular study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of the study groups. This means you will receive either one of the different doses of the new medicine, DC-806, or a placebo tablet (a dummy pill). You and your study doctor would not know which one you are receiving.

You would need to take the study tablets regularly as instructed. You would also attend several clinic visits over about 12 weeks. During these visits, doctors and nurses will check your skin carefully to see how your psoriasis is responding, using a special scoring system. They will also ask about any side effects you might be experiencing and perform some tests, like blood tests, to check your general health and measure the level of the medicine in your body. There will also be follow-up care after the main treatment period.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available and extra monitoring by medical professionals. However, there are also potential risks, including side effects from the study medicine or the possibility that the medicine may not help your condition. You might also receive a placebo and therefore not get any active treatment. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Spain
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Unverified
Poland
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Unverified
Hungary
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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 that causes red, scaly patches on your skin. It's not infectious.

What is a placebo?

A placebo is a 'dummy' tablet that looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare the real medicine against.

Will I know if I'm getting the study drug or the placebo?

No, this study is 'double-blind,' meaning neither you nor your study doctor will know whether you are receiving the active medicine or the placebo until the study ends.

What are 'side effects'?

Side effects are any unwanted or unexpected effects that happen while taking a medicine, which could be mild or more serious.

How long will I be in the study?

The main treatment period for assessing how well the medicine works is about 12 weeks, with additional follow-up visits.