Active not recruitingPHASE3INTERVENTIONAL

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)

This research is looking at a new medicine called remibrutinib for people aged 12 and over who have moderate to severe hidradenitis suppurativa (HS). HS is a skin condition that causes painful lumps and boils. The study will compare two different doses of remibrutinib to a 'placebo', which is a dummy pill with no active medicine. This helps doctors see if remibrutinib is truly effective. The main goals are to check how well the medicine works and if it's safe and causes any side effects. Taking part means you'd be helping doctors understand if this new treatment could be a good option for people with HS in the future.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

588

Start

31 Jan 2025

Estimated completion

04 Oct 2027

Hidradenitis Suppurativa

What is this study about?

This study is a research project focusing on hidradenitis suppurativa, often called HS. HS is a long-term skin condition that causes painful lumps and boils in places like armpits and groin. The study is testing a new medicine called remibrutinib. It's designed to see if this medicine can help people with moderate to severe HS feel better, improve their skin, and reduce their symptoms. This type of study, called a 'Phase 3' study, is usually the last step before a medicine might become widely available, so it's a very important stage of research.

Researchers want to find out two main things: how effective remibrutinib is and how safe it is. To do this, some participants will receive remibrutinib, while others will receive a placebo – a dummy pill that looks just like the study medicine but contains no active ingredients. This comparison is vital to make sure any improvements are really due to the medicine and not just other factors. Participants won't know if they're getting the active medicine or the placebo, and neither will their doctor, which makes the results more reliable.

The information gathered from this study will help healthcare professionals understand if remibrutinib could be a valuable new treatment option for people living with HS. By finding new treatments, we can hopefully improve the quality of life for many individuals affected by this challenging condition.

Key takeaways

Tests a new medicine for moderate to severe hidradenitis suppurativa (HS).
Open to people aged 12 and older.
Compares the new medicine to a dummy pill (placebo).
Helps doctors understand if remibrutinib is safe and effective.
Participation involves regular visits and lasts about 76 weeks.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 12 years old. You must have been diagnosed with hidradenitis suppurativa (HS) for at least six months and have a moderate to severe form of the condition. This means you have at least five active lumps or inflamed areas, and these affect at least two different parts of your body, such as both armpits.

There are also some reasons why you might not be able to join. For example, if you have a very large number of skin tunnels or fistulas (more than 20), or if you have another active skin condition that could make it hard to check your HS. You also can't have taken remibrutinib or similar medicines before. If you have any serious heart, kidney, liver, or breathing problems, a high risk of bleeding, or an active infection, you might not be able to take part.

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 12 years old or older?
Have you been diagnosed with HS for at least 6 months?
Do you have at least 5 inflamed lumps/areas that affect at least two different body parts?
Do you have fewer than 20 skin tunnels/fistulas?
Have you *not* taken this type of medicine (remibrutinib or similar) before?
Do you have any serious health conditions like a high bleeding risk, kidney issues, or active infections?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will last about 76 weeks in total, which is roughly a year and a half. This includes a short period of up to 4 weeks for initial checks to see if you're suitable. After that, you'll enter the main treatment period, which is split into two parts. For the first 16 weeks, you'll receive either remibrutinib or a dummy pill (placebo). For the next 52 weeks, you'll receive remibrutinib. Throughout the study, you'll have regular visits to the clinic so doctors can monitor your health, how your HS is doing, and check for any side effects. If you decide to leave the study at any point, you'll have a final check-up after 4 weeks to ensure everything is okay.

Potential risks and benefits

Taking part in a clinical trial sometimes offers potential benefits, like access to a new medicine before it's widely available, and dedicated medical care throughout the study. However, there are also potential risks, such as side effects from the study medicine, or that the medicine might not work for you, especially if you receive the placebo. Your health will be closely monitored, and you will always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (138)

Medical Dermatology Specialists
Verified postcode
Phoenix, United States
Johnson Dermatology
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Fort Smith, United States
Arkansas Research Trials
Verified postcode
North Little Rock, United States
Cheryl Effron MD Inc
Verified postcode
Anaheim, United States
Physioseq
Verified postcode
Sacramento, United States
Olive View UCLA Medical Center
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Sylmar, United States
Clinical Trials Research Institute
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Thousand Oaks, United States
Howard University College of Medicine
Verified postcode
Washington D.C., United States
Florida Academic Centers Research and Education LLC
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Coral Gables, United States
University of MiamiHealth System
Verified postcode
Miami, United States
Ziaderm Research LLC
Verified postcode
North Miami Beach, United States
Revival Research Institute LLC
Verified postcode
Evans, United States

Common questions

What is hidradenitis suppurativa (HS)?

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

What is a 'dummy pill' (placebo)?

A dummy pill looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare the real medicine's effects accurately.

How long will I be in the study?

The total study time is about 76 weeks (about a year and a half), including initial checks, treatment periods, and a follow-up.

Can I leave the study if I want to?

Yes, you can leave the study at any time, for any reason, without it affecting your other medical care. You'll just have a final safety check-up.

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

No, during the first part of the study, neither you nor your doctors will know if you're receiving remibrutinib or the placebo. This is to ensure the study results are fair and unbiased.