Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

This clinical trial is an extension study, meaning it's for people who have already been taking a new medicine called deucravacitinib for their moderate to severe plaque psoriasis. The main goal is to understand the long-term safety of this medicine by carefully tracking any side effects, both mild and serious. Researchers also want to see how well deucravacitinib continues to work over time to improve psoriasis symptoms. This is a Phase III study, which means it's a key step in testing new treatments before they can be made widely available. Participants will continue to receive the study medicine, and their skin condition will be regularly checked.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Enrolment target

664

Start

05 Apr 2024

Moderate-to-Severe Plaque Psoriasis

What is this study about?

This research study is looking into a new medicine called deucravacitinib for people who have moderate to severe plaque psoriasis. Psoriasis is a condition where your skin develops red, scaly patches, which can sometimes be itchy or painful. Moderate to severe means the patches cover a significant part of the body, or affect important areas like your hands, feet, or face.

The main purpose of this particular study is to be a continuation of earlier research. This means it's designed for people who have already taken part in a previous study with deucravacitinib. The researchers want to understand the long-term effects of this new medicine. They will be carefully watching for any side effects, both minor and serious, over an extended period. They also want to see how well the medicine continues to help improve psoriasis symptoms, like reducing the redness and scaling of your skin.

This is a 'Phase III' study, which is a very important stage in testing new medicines. At this stage, doctors are confirming that the medicine is safe and that it works well enough to potentially become available for general use. By taking part, you would be helping doctors learn more about managing psoriasis and potentially developing new and better treatments for the future.

Key takeaways

This is a follow-up study for a new psoriasis medicine called deucravacitinib.
It aims to understand the long-term safety and how well the medicine works.
Participants must be 18 years or older and already be in an earlier study for this medicine.
Regular clinic visits are needed to check your health and psoriasis.
Your participation helps to develop future treatments for psoriasis.
You can stop participating in the study at any time.

Who may be eligible?

To be part of this study, you must be 18 years old or older. Both men and women are welcome to participate. This study is specifically for people who are already taking part in a different study for the same medicine, deucravacitinib, for their moderate to severe plaque psoriasis.

Because this is an extension study, certain things might make you unable to join. For example, if you developed a new health condition or had specific side effects during the first part of the study, you might not be suitable for this follow-up. The research team will carefully review your medical history and current health to make sure this study is right for you and safe for you to participate in.

It's important to remember that all clinical trials have specific rules about who can join. This helps make sure the study is safe for participants and that the results are clear. The research team will discuss all the requirements 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 currently taking part in a study for deucravacitinib?
Do you have moderate to severe plaque psoriasis?
Are you 18 years old or older?
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 continue to receive the study medicine, deucravacitinib. In some cases, if you were receiving a placebo (a dummy pill) in the previous study, you would now start receiving the actual study medicine. You will have regular visits to the clinic so the study team can check your health and how your skin is responding to the treatment. They will ask you questions about your general health and any side effects you might be experiencing. They may also take blood and urine samples and perform physical examinations.

Each visit will involve assessments to measure the improvement of your psoriasis, such as looking at how much of your body is affected and the severity of your skin patches. The exact number of visits and the total length of your participation will be explained by the study team. Over time, these assessments will help the researchers understand the long-term effects of the medicine. It's a commitment, but your involvement is very valuable.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as continuing to receive a new medicine that may improve your psoriasis symptoms under close medical supervision. However, like all medicines, deucravacitinib may have side effects, which could be mild or more serious. The study team will monitor you closely for any adverse reactions throughout your participation. You will be fully informed about all known risks before you decide to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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
Germany
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Unverified
Sweden
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Unverified
France
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Unverified
Poland
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Unverified
Finland
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Unverified
Spain
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Unverified
Czechia

Common questions

What is 'plaque psoriasis'?

Plaque psoriasis is a common skin condition where your body produces skin cells too quickly, leading to red, scaly, and sometimes itchy patches on your skin.

What is deucravacitinib?

Deucravacitinib is the name of the new medicine being tested in this study to help treat moderate to severe plaque psoriasis.

What does 'long-term safety and efficacy' mean?

It means the study will check if the medicine is safe to take over a longer period and how well it continues to work to improve your psoriasis symptoms over time.

Will I get the actual medicine or a dummy pill?

As an extension study, if you were on a dummy pill in the previous study, you would likely now receive the active medicine. The study team will explain exactly what you will receive.

What is a 'Phase III' study?

Phase III is a key stage of research where a new medicine is tested on a larger group of people to confirm it's safe and effective before it can be made available more widely.