Active not recruitingPHASE2INTERVENTIONAL

Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis

This study is an extension of previous research into a new medicine, envudeucitinib, for people with widespread plaque psoriasis. It's designed for those who have already completed an earlier study with this same medication. The main aim is to understand the long-term safety and how well envudeucitinib works over a longer period. Participants will continue to receive the study medicine, envudeucitinib, at one of two dose levels, and they can stay in the study until the medicine might become widely available. This helps researchers gather more information about its effects over time, which is important for understanding how new treatments work.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Alumis Inc

Enrolment target

165

Start

17 Jan 2023

Estimated completion

30 Dec 2026

Plaque Psoriasis

What is this study about?

This study is about a new medicine called envudeucitinib for a skin condition called plaque psoriasis. Plaque psoriasis makes your skin develop red, scaly patches that can be itchy or sore. Researchers are trying to find new ways to help people manage this condition.

Think of this study as the next chapter in understanding envudeucitinib. It's specifically for people who have already taken part in an earlier study investigating this medicine. By continuing to follow these participants, the researchers can learn more about how safe the medicine is and how well it works over a longer period. This kind of long-term information is really important for deciding if a new medicine is effective and has acceptable side effects.

If you join this study, you would keep taking envudeucitinib, just like in the previous study. The researchers want to see how your body reacts to the medicine over many months or even years. This helps them understand its full impact, and potentially brings us closer to new treatment options for plaque psoriasis. You could even stay in the study until the medicine is available more generally.

Key takeaways

It's an extension study for a psoriasis medicine called envudeucitinib.
Only for people who completed a previous study with envudeucitinib.
Aims to understand long-term safety and effectiveness.
Participants will continue to receive the study medicine.
You can stay in the study until the medicine might become generally available.
Contribution helps gain more knowledge about new psoriasis treatments.

Who may be eligible?

To be part of this study, you must have already completed a previous study involving the medicine 'ESK-001' for plaque psoriasis. This particular study is only open to people who have already had experience with this specific medication in a research setting.

Both men and women who join this study must agree to use very effective methods of contraception (birth control) throughout the entire study. This is to prevent pregnancy while taking the study medicine.

You cannot take part if you are pregnant or if you are using certain other medications that might interfere with the study medicine. The study team would discuss all these details with you to make sure it's safe for you to participate.

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.

I have already completed a previous study with the medicine ESK-001 for plaque psoriasis.
I am 18 years old or older.
If I am a woman, I am not pregnant and will use highly effective birth control.
If I am a man, I will use highly effective birth control.
I am not currently taking other specific medications that would prevent me from joining.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will continue to receive the study medicine, envudeucitinib. There are two different dose levels, and the study team will let you know which one you would receive. This is an "open-label" study, which means both you and the study team will know which dose you are taking.

You will have regular visits to the clinic so the doctors can check on your health, how your psoriasis is doing, and if the medicine is causing any side effects. They will likely do physical exams, blood tests, and ask you questions about your well-being. These visits help the researchers keep track of your progress and safety.

The great thing about this study is that you can choose to stay in it for a longer time, even until the medicine might become widely available outside of a study. The total duration for each person will vary depending on when the medicine might be approved and released.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A possible benefit is that envudeucitinib might continue to help manage your plaque psoriasis, and you'd have continued access to the treatment. You would also be contributing valuable information that could help others with psoriasis in the future. However, there's always a chance the medicine might not work for you, or you could experience side effects. The study team will explain all known potential side effects. Remember, joining is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (38)

Investigator Site # 1029
Verified postcode
Birmingham, United States
Investigator Site #1001
Verified postcode
Phoenix, United States
Investigator Site # 1023
Verified postcode
Rogers, United States
Investigator Site #1021
Verified postcode
Encinitas, United States
Investigator Site #1018
Verified postcode
Los Angeles, United States
Investigator Site #1007
Verified postcode
Santa Monica, United States
Investigator Site #1002
Verified postcode
Sherman Oaks, United States
Investigator site # 1030
Verified postcode
Fort Lauderdale, United States
Investigator Site #1025
Verified postcode
Hialeah, United States
Investigator site # 1028
Verified postcode
Miami, United States
Investigator Site # 1013
Verified postcode
Tampa, United States
Investigator Site #1035
Verified postcode
Macon, United States

Common questions

What is the main goal of this study?

The main goal is to check the long-term safety and how well a medicine called envudeucitinib works for plaque psoriasis in people who have already used it.

Do I have to take part if I was in the previous study?

No, taking part is completely optional. This study is an opportunity if you want to continue accessing the medicine and contributing to research.

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

In this study, everyone gets the active medicine, envudeucitinib. It's an 'open-label' study, meaning you and the doctors will know what you're receiving.

How long will I be in the study?

You have the option to stay in the study for a longer period, possibly until the medicine is available to buy outside of a study. The exact time will vary.

What if I get pregnant during the study?

It's important to use effective contraception throughout the study. If you become pregnant, you would need to leave the study for safety reasons.