RecruitingPHASE3INTERVENTIONAL

A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

This study is testing a drug called upadacitinib for people aged 12 and over who have moderate to severe Hidradenitis Suppurativa (HS). HS is a skin condition causing painful bumps, often in areas like armpits or groin. Participants will have already tried and not responded well to a type of treatment called anti-TNF therapy. The main goal is to find out how safe and effective upadacitinib is in treating HS. Upadacitinib is already used for other conditions like arthritis. This is a "double-blind" study, meaning no one knows who gets the real drug and who gets a dummy pill (placebo). About 1300 people worldwide will take part, taking tablets daily and attending regular check-ups.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

1,328

Start

21 Jun 2023

Estimated completion

01 Mar 2028

Hidradenitis Suppurativa

What is this study about?

This study aims to discover if a medication called upadacitinib can help adults and teenagers who have moderate to severe Hidradenitis Suppurativa (HS). HS is a chronic skin condition that causes painful lumps and boils, often in body folds like the armpits, groin, or around the bottom. It can be very uncomfortable and affect daily life. The study is specifically for those whose HS hasn't improved enough with a common type of treatment called anti-TNF therapy.

Upadacitinib is a drug that's already approved and used for several other inflammatory conditions, such as certain types of arthritis and eczema. Researchers are now investigating its potential to treat HS. The study will closely monitor participants to see how much their HS symptoms improve and whether they experience any side effects from taking the medication.

To ensure fair and reliable results, this is a "double-blind" study. This means that neither the participants nor the doctors involved will know whether someone is receiving the active drug (upadacitinib) or a placebo (a dummy pill with no active medicine). This approach helps to prevent bias and gives a clearer picture of the drug's true effects. The study will involve a large number of people from many different locations around the world.

Key takeaways

Tests a new daily tablet (upadacitinib) for moderate to severe HS.
For adults and teenagers (12+) who haven't improved with other treatments (anti-TNF).
Study is 'double-blind' – you might get the active drug or a dummy pill.
Involves regular clinic visits, assessments, and questionnaires over a long period.
Could offer a new treatment option, but side effects are possible.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 12 years old and have been diagnosed with Hidradenitis Suppurativa (HS) for at least six months. Your HS should be moderate to severe, meaning you have a certain number of painful lumps and bumps, and it affects at least two different body areas. Importantly, you must have already tried and not found enough relief from at least one type of anti-TNF treatment.

Things that might prevent you from joining include having other active skin infections that could make it hard to check your HS, or if you've recently taken other experimental drugs. You also shouldn't have had certain strong cell-targeting treatments in the past year, or have recently used certain skin creams or antibiotics for your HS or other inflammatory conditions.

Quick self-check

Are you at least 12 years old?
Do you have a diagnosis of moderate to severe Hidradenitis Suppurativa (HS)?
Has your HS not responded well to at least one anti-TNF treatment?
Do you have HS in at least two body areas and a certain number of painful lumps?
Have you avoided certain other skin treatments or antibiotics recently?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will take tablets either of upadacitinib or a dummy pill (placebo) once a day. This will continue for about 36 weeks in the first part of the study. Depending on your progress, you might then continue with daily tablets for another 68 weeks in the long-term part of the study. In total, your participation will involve taking medication for up to 104 weeks.

You will need to attend regular visits to a clinic. During these visits, medical staff will check your health, assess your HS symptoms, and look out for any side effects. You'll also be asked to complete questionnaires about how you're feeling and how the treatment is affecting you. After you stop taking the study medication, there will be a final check-up about 30 days later. You might find you have more appointments and assessments than you would with your usual HS care.

Potential risks and benefits

Taking part in this study could potentially offer you a new treatment option for your Hidradenitis Suppurativa if your current treatments haven't been effective. Upadacitinib might help reduce your HS symptoms and improve your quality of life. However, like all medications, upadacitinib can cause side effects, and some participants will receive a placebo which will not treat their HS. Doctors will closely monitor your health for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (285)

Cahaba Dermatology & Skin Health Center /ID# 254876
Birmingham, United States· Recruiting
Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564
Fountain Hills, United States· Recruiting
Medical Dermatology Specialists /ID# 254226
Phoenix, United States· Recruiting
Mayo Clinic - Scottsdale /ID# 254388
Scottsdale, United States· Recruiting
Banner University Medicine Dermatology /ID# 255853
Tucson, United States· Recruiting
Clinical Trials Institute - Northwest Arkansas /ID# 254924
Fayetteville, United States· Recruiting
Burke Pharmaceutical Research /ID# 254238
Hot Springs, United States· Recruiting
Arkansas Research Trials /ID# 254233
North Little Rock, United States· Recruiting
NW Arkansas Clinical Trials Center /ID# 254311
Rogers, United States· Recruiting
Private Practice - Dr. Tooraj Raoof /ID# 254374
Encino, United States· Recruiting
Marvel Clinical Research /ID# 276228
Huntington Beach, United States· Recruiting
Dermatology Research Associates /ID# 254846
Los Angeles, United States· Recruiting

+273 more sites — see the official record for the full list.

Common questions

What is Hidradenitis Suppurativa (HS)?

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

What is Upadacitinib?

Upadacitinib is a medication already approved for other conditions like arthritis. This study is testing if it can also help people with HS.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are receiving the active drug (upadacitinib) or a dummy pill (placebo). This helps ensure the study results are accurate.

Will I definitely get the active drug?

No, in the first part of the study, there's a 1 in 2 chance you might receive the placebo (dummy pill) instead of upadacitinib.

How long will I be in the study?

The study involves different periods, with treatment lasting up to 104 weeks (about two years), plus a follow-up visit about a month later.

How to find out more

ABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com 844-663-3742 Official trial record

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