Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa

This research study is looking at a new medicine called Izokibep. It's for adults in the UK who have hidradenitis suppurativa (HS), a skin condition that causes painful lumps and abscesses. The study aims to find out if Izokibep is effective and safe in treating moderate to severe HS. Participants will receive either Izokibep or a dummy medicine (placebo) without knowing which one they have. Researchers will carefully check how people's HS symptoms change, how the medicine affects their quality of life, and if there are any side effects. The main goal is to see if Izokibep significantly improves HS after 12 weeks of treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Acelyrin Inc.

Enrolment target

Start

13 Nov 2023

Hidradenitis Suppurativa

What is this study about?

This study is testing a new medicine named Izokibep for adult patients who have moderate to severe hidradenitis suppurativa (HS). HS is a chronic, often painful, skin condition that causes lumps, boils, and abscesses, mainly in areas like the armpits and groin. Living with HS can be very challenging, affecting daily life and well-being.

The main purpose of this study is to see how well Izokibep works and if it's safe compared to a placebo, which is a dummy medicine containing no active drug. This type of study, where some people get the new medicine and others get the placebo, helps scientists understand the true effects of the new treatment. Both patients and their doctors won't know if they are receiving Izokibep or the placebo, which helps ensure the results are fair and unbiased. The study will look closely at how much HS symptoms improve, such as the number of sores and abscesses, and how it affects the pain patients feel and their general quality of life.

By participating, you could help doctors learn more about Izokibep as a potential treatment option for HS. This information is crucial for developing new medicines that could improve the lives of many people with this condition. The study is designed to be very thorough, carefully tracking changes in your condition, any side effects you might experience, and your overall health throughout the treatment period.

Key takeaways

This study is for adults with moderate to severe hidradenitis suppurativa (HS).
It tests a new medicine called Izokibep against a dummy medicine (placebo).
The main goal is to see if Izokibep improves HS symptoms and is safe after 12 weeks.
Participation involves regular clinic visits, health checks, and questionnaires.
You will not know if you are receiving Izokibep or the placebo.
Your decision to join or leave the study is always respected and won't affect your normal care.

Who may be eligible?

This study is looking for adult volunteers who have hidradenitis suppurativa (HS). To be considered, you must be 18 years old or older.

Your HS needs to be considered 'moderate to severe', which means it's causing noticeable problems and might not be fully controlled by your current treatments. Both men and women are welcome to take part in this study.

There will be other specific health requirements for joining, which your study doctor will discuss with you. These are in place to make sure the study is safe for everyone involved and that the results are clear.

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 been diagnosed with hidradenitis suppurativa (HS)?
Is your HS considered moderate to severe by your doctor?
Are you able to attend regular clinic appointments for checks?
Are you open to potentially receiving a placebo (dummy medicine)?
Are you willing to discuss all your current medications and health conditions with the study doctors?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if the study is right for you. If you qualify, you would primarily receive either the study medicine, Izokibep, or a placebo (a dummy medicine) for 12 weeks. Neither you nor your study doctor will know which one you are getting.

Throughout the study, you would attend several visits to the clinic. During these visits, the study team would check your HS symptoms, take blood and urine samples, measure your vital signs (like blood pressure), and ask you about any changes in your health or any side effects you might be having. You would also be asked to answer questionnaires about your pain and how HS affects your quality of life.

The medication is likely given as an injection. The total duration of your active involvement in the study, including follow-up after the 12-week treatment period, will be explained by the study team.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new investigational treatment for your HS and having your health closely monitored by a team of experts. This could lead to an improvement in your symptoms or quality of life, though this is not guaranteed. However, there are also potential risks, including side effects from the study medicine, which could be mild or severe, or that the treatment might not improve your condition. All possible risks will be fully explained to you before you agree to participate. You are 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
Hungary
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Unverified
France
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Unverified
Spain
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Unverified
Germany
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Unverified
Poland

Common questions

What is hidradenitis suppurativa (HS)?

HS is a long-term skin condition that causes painful lumps, boils, and a type of abscess to form, usually in areas where skin rubs together, like the armpits or groin.

What is Izokibep?

Izokibep is a new medicine being tested to see if it can help treat moderate to severe HS.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks just like the real medicine but contains no active drug. It helps researchers understand if the new medicine is truly effective.

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

No, neither you nor your study doctor will know whether you are receiving Izokibep or the placebo during the main part of the study. This is called 'double-blind' and ensures the results are fair.

How long does the study last?

The main treatment period is 12 weeks, but your full participation, including follow-up, will be explained by the study team and will likely be longer.