Active not recruitingPHASE2INTERVENTIONAL

A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)

This research study is looking at a new medicine called brensocatib for adults who have hidradenitis suppurativa (HS). HS is a long-term skin condition causing painful lumps and abscesses. We want to find out if brensocatib can help reduce these symptoms and if it's safe to use. Some participants will receive the new medicine, while others will receive a placebo (a dummy medicine with no active ingredients). This helps us compare the effects directly. The study is particularly for those with moderate to severe HS that has been present for at least six months. This type of research is an important step in finding new and better treatments for HS.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Insmed Incorporated

Enrolment target

214

Start

16 Dec 2024

Estimated completion

17 Nov 2026

Hidradenitis Suppurativa

What is this study about?

This study is about a new medicine called brensocatib and how it might help people with hidradenitis suppurativa, often called HS. HS is a long-term skin condition that causes painful, inflamed lumps and abscesses, mainly in areas where skin rubs together, like the armpits or groin. These can sometimes burst and form tunnels under the skin, which can be very uncomfortable.

The main goal of this research is to see if brensocatib works better than a placebo, which is a dummy medicine that looks the same but contains no active ingredients. Giving some participants the active medicine and some the placebo helps doctors understand if any changes or improvements are truly due to brensocatib or if they might happen naturally. We also want to make sure the medicine is safe to use and doesn't cause too many side effects.

Finding new ways to treat HS is really important because it can be a challenging condition to live with. This study could help us learn more about brensocatib and whether it could become a useful treatment option for people with moderate to severe HS in the future. Studies like this are how new treatments are discovered and approved to help patients.

Key takeaways

This study is testing a new medicine for moderate to severe HS.
It aims to see if brensocatib is safe and effective compared to a dummy pill (placebo).
Participation involves regular clinic visits and close monitoring of your health.
You might receive the active medicine or a placebo, and you won't know which one.
The study could help find new treatments for HS. You can leave the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old, and you must have hidradenitis suppurativa (HS) that a skin doctor has confirmed. Your HS needs to have been present for at least six months and be considered moderate to severe, meaning you have at least six active painful lumps or pus-filled spots.

Your HS also needs to affect at least two different body areas, and at least one of these areas should be quite severe (what doctors call Hurley Stage II or III). You won't be able to join if you have many draining tunnels (20 or more) or if you've had surgery or laser treatment for your HS recently.

There are also some medical conditions and recent treatments that might prevent you from joining, such as certain blood conditions, active liver disease, or if you've recently taken certain strong antibiotics or other medicines for HS. This is 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 between 18 and 80 years old?
Has a skin doctor confirmed you have HS, and have you had it for at least 6 months?
Do you currently have at least 6 active HS lumps or pus-filled spots?
Does your HS affect at least two different body areas, with at least one being quite severe?
Have you avoided surgery or laser treatment for HS in the last few weeks?
Have you recently stopped or changed certain HS medications (like strong antibiotics or biologics) as per the study rules?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned either to receive the study medicine (brensocatib) or a dummy medicine (placebo). You won't know which one you're getting, and neither will your study doctor. You'll need to visit the clinic regularly for check-ups, where the study team will monitor your HS, take blood samples, and ask about your health and any side effects. You might also need to keep a diary of your symptoms. The study will involve taking the medicine for a set period, followed by follow-up visits. The total duration of your involvement in the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be that the new medicine helps improve your HS symptoms. Even if you receive the placebo, your condition will be closely monitored by medical professionals. On the other hand, there might be side effects from the medicine, or it might not help your HS. All potential risks will be fully explained to you before you decide to join. Remember, taking part 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 (72)

USA001
Verified postcode
Phoenix, United States
USA007
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Sacramento, United States
USA026
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Coral Gables, United States
USA027
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Hollywood, United States
USA021
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Margate, United States
USA018
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Miami, United States
USA025
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Ocala, United States
USA004
Verified postcode
Tampa, United States
USA010
Verified postcode
Weston, United States
USA028
Verified postcode
Atlanta, United States
USA011
Verified postcode
Sandy Springs, United States
USA003
Verified postcode
Plainfield, United States

Common questions

What is hidradenitis suppurativa (HS)?

HS is a long-term skin condition that causes painful lumps, abscesses, and sometimes tunnels under the skin, usually in areas like the armpits, groin, or under the breasts.

What does 'placebo' mean?

A placebo is a dummy medicine that looks like the real study drug but contains no active ingredients. It helps researchers see if the real medicine has a genuine effect.

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

No, during the study, neither you nor the doctors will know whether you are receiving brensocatib or the placebo. This is to keep the study fair and unbiased.

Can I leave the study at any time?

Yes, taking part is voluntary, and you can withdraw from the study at any time, for any reason, without affecting your regular medical care.

What is the purpose of this study?

The main purpose is to see if brensocatib is safe and effective in treating moderate to severe HS compared to a placebo.