RecruitingPHASE3INTERVENTIONAL

Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)

This study is investigating a new cream for a skin condition called hidradenitis suppurativa (HS). HS causes painful lumps under the skin. The cream, called ruxolitinib, is being tested to see how effective and safe it is for people with mild to moderate HS. Participants will be split into groups; some will use the active ruxolitinib cream, while others will use a 'vehicle cream' – this looks the same but doesn't contain the active medicine. This helps researchers compare the effects accurately. The study is a Phase 3 trial, which means it's a larger study that follows earlier successful tests and is often a step towards a new treatment becoming widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Incyte Corporation

Enrolment target

550

Start

23 Jun 2025

Estimated completion

11 Jul 2027

Hidradenitis Suppurativa

What is this study about?

Hidradenitis Suppurativa (HS) is a long-term skin condition that causes painful lumps and abscesses, often in places like the armpits, groin, and under the breasts. It can be uncomfortable and impact daily life. Doctors are always looking for better ways to manage HS and ease symptoms. This particular study is testing a new cream called ruxolitinib to see if it can help people with HS.

Think of this study as a careful test to understand if ruxolitinib cream is a useful treatment for HS. Researchers want to find out two main things: first, how well the cream works to improve HS symptoms (this is called 'efficacy'), and second, whether it causes any unwanted side effects (this is called 'safety'). If the cream proves to be both effective and safe, it could become a new treatment option for people living with HS in the future.

Taking part in a study like this is important because it helps medical science advance. Every new treatment starts with research, and patient volunteers are essential to figuring out which treatments work best. This particular study focuses on people with milder to moderate forms of HS, and it's looking specifically at a cream that you apply to the skin.

Key takeaways

This study is testing a new cream (ruxolitinib) for hidradenitis suppurativa (HS).
It's for people with mild to moderate HS, aiming to see how well the cream works and if it's safe.
Participants will use either the active cream or a 'dummy' cream.
You'll need regular clinic visits and agree to certain restrictions on other HS treatments.
Participation helps advance research into better HS treatments.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to have been diagnosed with hidradenitis suppurativa (HS) for at least six months. Your HS should be considered mild to moderate, meaning you have certain types of lumps (Doctors call these lesions 'AN count') in at least two different body areas, but without any deep draining tunnels.

There are also some things that might mean you can't join. For example, if your HS covers a very large area of your body, or if you have those deep draining tunnels. You also can't be pregnant or breastfeeding, or planning to become pregnant during the study. Additionally, if you have certain other health conditions, infections, or issues with your blood tests, 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.

Have you been diagnosed with hidradenitis suppurativa for at least 6 months?
Is your HS considered mild to moderate (Hurley I or II) without deep draining tunnels?
Do you have lumps (AN count) in at least two different spots?
Are you able to avoid using certain other HS treatments during the study?
Are you currently pregnant or breastfeeding, or planning to become so during the study?
Does your HS affect less than 20% of your total body surface area?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be given either the ruxolitinib cream or a 'dummy' cream (vehicle cream) to apply to your skin. You'll need to agree not to use certain other creams, washes, or strong medicines (like antibiotics) for your HS during the first part of the study, so doctors can properly see how the study cream works. You will have regular visits to the clinic so the study team can check your skin, record your symptoms, and make sure you're doing well. These visits will involve physical examinations and possibly blood tests. The study will last for a certain period, and you'll get detailed information about the schedule of visits and what each visit involves before you decide to take part. The exact number of visits and the total duration would be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and contributing to medical research that could help others with HS in the future. However, there are also potential risks, including possible side effects from the cream, which the study team will explain in detail. You might also find the regular clinic visits time-consuming. Because you might receive the 'dummy' cream, there's a chance you won't get the active treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (101)

Investigative Site US020
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Phoenix, United States· Recruiting
Investigative Site US033
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Scottsdale, United States· Recruiting
Investigative Site US054
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Tempe, United States· Recruiting
Investigative Site US002
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Fayetteville, United States· Recruiting
Investigative Site US055
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Brea, United States· Recruiting
Investigative Site US004
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Laguna Niguel, United States· Recruiting
Investigative Site US007
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Los Angeles, United States· Recruiting
Investigative Site US013
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San Diego, United States· Recruiting
Investigative Site US060
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San Diego, United States· Recruiting
Investigative Site US038
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San Diego, United States· Recruiting
Investigative Site US059
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Aurora, United States· Recruiting
Investigative Site US045
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Boynton Beach, United States· Recruiting

Common questions

What is hidradenitis suppurativa (HS)?

HS is a chronic skin condition that causes painful, often recurring, lumps and abscesses in parts of the body where skin rubs together, like the armpits or groin.

What is ruxolitinib cream?

It's a cream being tested to see if it can help improve symptoms of HS. It's not yet approved for general use for HS.

What does 'Phase 3' mean for a clinical trial?

Phase 3 means it's a larger study, following earlier successful tests, to confirm if the treatment is effective and safe before it can be considered for wider use.

Will I definitely get the active cream?

Not necessarily. In this type of study, some participants receive the active ruxolitinib cream, while others receive a 'dummy' cream (vehicle cream) for comparison.

Can I use my usual HS medicines during the study?

No, during parts of the study, you would need to agree not to use other common topical or systemic HS treatments like antibiotics on the affected areas, so the study cream's effects can be clearly seen.

How to find out more

Incyte Corporation Call Center (US)

medinfo@incyte.com 1.855.463.3463 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.