Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Plaque Psoriasis

This research study is for adults, 18 years and older, who have moderate to severe plaque psoriasis. Psoriasis is a skin condition that causes red, scaly patches. The study is testing a new tablet called SCD-044. Some people will receive different doses of SCD-044, while others will get a 'dummy' tablet (placebo) that looks the same but contains no active medicine. The main goal is to find out if SCD-044 can significantly improve psoriasis symptoms, specifically if it can clear up at least 75% of the skin patches, compared to the dummy tablet, after 16 weeks. Researchers will also be checking for any side effects to make sure the treatment is safe. Taking part is voluntary, and you'll be contributing to important medical research for psoriasis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sun Pharmaceutical Industries Limited

Enrolment target

Start

02 Feb 2024

moderate to severe plaque psoriasis

What is this study about?

This study is all about a skin condition called plaque psoriasis. If you have moderate to severe plaque psoriasis, you know it can cause patches of red, scaly skin that can be itchy or uncomfortable. Doctors and scientists are always looking for better ways to help people manage this condition. That's why this study is testing a new tablet called SCD-044.

The main idea is to see if SCD-044 can make a real difference in how much your psoriasis improves. Researchers will be looking to see if people taking SCD-044 have at least 75% less psoriasis on their skin compared to how it was at the start of the study. This is an important step in finding new treatments, and the study will also very carefully look at any side effects people might experience, to make sure the drug is safe.

The study is in an early stage (what doctors call 'Phase II'). This means it's one of the first times this tablet is being tested in a larger group of people to see if it works and what the best dose might be. Finding new and effective treatments can really improve the quality of life for people living with psoriasis.

Key takeaways

This study is for adults (18+) with moderate to severe plaque psoriasis.
It's testing a new tablet, SCD-044, against a dummy pill (placebo).
The main goal is to see if SCD-044 improves psoriasis after 16 weeks.
Safety and side effects will be carefully monitored.
Participation involves regular clinic visits and medication doses.
You won't know if you're taking the active drug or the placebo.

Who may be eligible?

This study is looking for adults who are 18 years or older. There is no upper age limit, meaning people of all adult ages can potentially take part. The study is open to both men and women.

To be considered, you also need to have plaque psoriasis that is classified by doctors as moderate to severe. This typically means your psoriasis affects a noticeable area of your body and/or significantly impacts your daily life.

There will be other, more detailed health checks to make sure the study is a good fit for you and that it's safe for you to take part. For example, doctors will need to check your general health, other medical conditions, and medications you might be taking.

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 that a doctor describes as 'moderate to severe'?
Are you able to attend regular clinic appointments?
Are you comfortable potentially receiving a dummy pill instead of the active medicine?
Do you understand that there will be other medical checks to confirm if you can join?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given one of four different doses of the SCD-044 tablet, or a 'dummy' tablet (placebo). Neither you nor your study doctor would know which one you are taking – this is to make sure the results are as fair as possible. You would take these tablets regularly as instructed.

Throughout the study, you would have regular visits to the clinic. At these visits, doctors and nurses would check your psoriasis, ask about any side effects, and perform other tests like blood samples or physical examinations. This helps them understand how the treatment is working and if it's safe for you. The main part of the study lasts for 16 weeks, and there might be follow-up checks after that time.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You would receive close medical attention and regular check-ups for your psoriasis, and there's a chance your psoriasis could improve significantly if you receive the active study drug. On the other hand, there are potential risks, as with any medication. You might experience side effects from the study drug, or you might receive the dummy pill and not see any improvement in your psoriasis. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Poland
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Unverified
Estonia

Common questions

What is a 'dummy tablet' (placebo)?

It's a tablet that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real drug's effects.

Will I know if I'm getting the real medicine or the dummy tablet?

No, neither you nor your study doctor will know. This is called 'double-blind' and makes the study results more reliable.

How long will I be in the study?

The main treatment period for this study is 16 weeks, with potential follow-up visits afterwards.

What if I feel unwell during the study?

Your health will be closely monitored, and you should tell the study team immediately if you experience any new or worsening symptoms.

What does 'moderate to severe plaque psoriasis' mean?

This refers to psoriasis that covers a significant area of your body or severely impacts your daily life, as assessed by a doctor.