Active not recruitingPHASE3INTERVENTIONAL

Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis

This study, called ESK-001-018, is designed to understand the long-term safety and how well a new medicine, ESK-001, works for people with moderate to severe plaque psoriasis. It's a continuation for patients who have already taken part in an earlier ESK-001 study. Researchers want to find out if taking ESK-001 for a longer period is safe and if it continues to improve psoriasis symptoms. Participants will start by receiving the active medicine, and then some may be randomly guided to receive either the active medicine or a dummy treatment (placebo) for a period, under close medical supervision, to help doctors understand the treatment better.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alumis Inc

Enrolment target

1,680

Start

08 Jan 2025

Estimated completion

01 Nov 2028

Plaque Psoriasis Psoriasis (PsO)Psoriasis Moderate Psoriasis Severe Psoriasis

What is this study about?

This study is a long-term look at a new medicine called ESK-001 for people living with moderate to severe plaque psoriasis. Psoriasis is a condition where skin cells build up quickly, causing red, scaly patches. Doctors are interested in how safe this new medicine is when taken over a longer period, and how well it continues to help reduce the severity of psoriasis symptoms.

To join this study, you must have already taken part in one of the previous ESK-001 studies (ESK-001-016 or ESK-001-017). This allows doctors to further follow your progress and gather more information about the medicine's effects over time. The study aims to answer important questions about the safety of ESK-001 for long-term use and whether it effectively keeps psoriasis under control.

Initially, all participants will receive the active ESK-001 medicine twice a day for about 24 weeks. After this, some patients whose psoriasis has responded well to the treatment will be randomly selected to either continue with ESK-001 or switch to a dummy treatment (placebo) for a while. This helps researchers understand the true benefits of the medicine. If someone's psoriasis worsens during this time, they can go back to receiving the active ESK-001. Everyone who completes a certain point in the study will then go back to taking the active ESK-001 until the study finishes or they choose to stop.

Key takeaways

This study is for long-term follow-up of a new psoriasis medicine (ESK-001).
Only people from previous ESK-001 studies (ESK-001-016 or -017) can join.
It aims to check long-term safety and how well the medicine works.
Participation involves taking medicine and regular clinic visits for check-ups and samples.
Some participants may temporarily switch between active medicine and placebo for part of the study.
You must agree to use effective contraception if needed.

Who may be eligible?

To be considered for this study, you must be at least 18 years old, whether you are a man or a woman. A key requirement is that you must have already successfully completed one of the previous studies involving ESK-001 (either ESK-001-016 or ESK-001-017), and the doctors must have been happy with how you reacted to the medicine in that earlier study.

It's important that you are not pregnant, breastfeeding, or planning to become pregnant during the study. If you are a woman who could get pregnant, or a man who is sexually active with someone who could get pregnant, you must agree to use highly effective birth control throughout your time in the study.

You cannot join if you have any other serious health issues that your study doctor thinks would make it unsafe for you to continue with ESK-001. Your doctor must also agree that this study is suitable for you and that you will be able to follow all the study rules.

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?
Have you completed a previous ESK-001 study (ESK-001-016 or ESK-001-017)?
Are you not pregnant, breastfeeding, or planning to get pregnant during the study?
Are you willing and able to use reliable contraception if you or your partner could become pregnant?
Do you have any other serious health conditions that might make it unsafe to take part?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will need to take the study medicine, ESK-001, usually twice a day. It's really important to take your medicine exactly as instructed throughout the study. You'll also need to attend regular check-ups at the clinic. These visits are where the study team will monitor your health and how your psoriasis is responding to the treatment. During these check-ups, you'll be asked to provide blood and urine samples so doctors can keep track of your health and the medicine's effects. The study duration varies, but for some, it could be until the study officially ends or you decide to stop.

Potential risks and benefits

Taking part in this study might offer the benefit of continued access to a new treatment, ESK-001, which could help manage your moderate to severe plaque psoriasis. However, as with all medicines, there could be side effects or risks, some of which may not be fully known yet. You will be closely monitored for any health changes. Remember, joining a study is always your choice, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (268)

Total Dermatology
Verified postcode
Birmingham, United States
Chandler Clinical Trials
Verified postcode
Chandler, United States
Alliance Dermatology
City only
Pheonix, United States
Scottsdale Clinical Trials
Verified postcode
Scottsdale, United States
Noble Clinical Research
Verified postcode
Tucson, United States
Northwest AR Clinical Trials Center PLLC
Verified postcode
Rogers, United States
Zenith Research Inc.
Verified postcode
Beverly Hills, United States
Exalt Clinical Research Inc
Verified postcode
Chula Vista, United States
California Dermatology and Clinical Research Institute
Verified postcode
Encinitas, United States
Raoof MD
Verified postcode
Encino, United States
First OC Dermatology Research Inc
Verified postcode
Fountain Valley, United States
Marvel Clinical Research LLC
Verified postcode
Huntington Beach, United States

Common questions

What is ESK-001?

ESK-001 is a new medicine being tested for people with moderate to severe plaque psoriasis.

What does 'long-term extension' mean?

It means this study is a continuation for people who have already taken part in an earlier study of ESK-001, to see how the medicine works over more time.

Will I always receive the active medicine?

Initially, yes. Later, some patients whose psoriasis has responded well may be randomly assigned to either continue ESK-001 or take a dummy treatment for a period, but you can return to ESK-001 if needed.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but contains no active drug, used to help compare effects.

Can I join if I haven't been in a previous ESK-001 study?

No, this study is only for those who have already completed one of the specific previous ESK-001 studies.