RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

This research is investigating a daily tablet called upadacitinib for severe alopecia areata. This is a condition where the body's defence system mistakenly attacks hair follicles, leading to hair loss, often on the head but sometimes elsewhere. The study wants to find out if upadacitinib is safe, works well, and is easy to take for adults and teenagers with severe alopecia areata. Upadacitinib is already a approved medicine but is being tested for this specific condition. Participants will take either upadacitinib or a dummy (placebo) tablet. The study involves regular hospital or clinic visits, medical checks, blood tests, and questionnaires to see how the treatment is working and if there are any side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

1,500

Start

11 Oct 2023

Estimated completion

01 Apr 2030

Alopecia Areata

What is this study about?

Alopecia areata is a condition where your body's immune system, which normally fights off germs, mistakenly attacks your hair follicles. This can cause hair to fall out, often in patches on the head, but it can affect any part of the body. This study wants to explore a new tablet treatment called upadacitinib for people, including teenagers and adults, who have severe alopecia areata.

Upadacitinib is a medicine that is already approved for other conditions, and now researchers are hoping it might help with alopecia areata. The main goal is to understand how well the medicine works to help hair regrow, how safe it is to take, and if people find it manageable. The study will compare upadacitinib with a placebo, which is a dummy tablet that looks like the real medicine but contains no active drug. This helps researchers really see the effect of upadacitinib.

Taking part would mean you'd receive either the study drug or the placebo as a daily tablet. The study is quite large, involving around 1500 people from many different places. Participants will be carefully monitored over a long period, up to three years, to track their progress and safety. It's a comprehensive look at a potential new treatment for hair loss caused by severe alopecia areata.

Key takeaways

This study tests a daily tablet called upadacitinib for severe alopecia areata.
It aims to find out if the medicine is safe and effective in helping hair regrow.
Participants will receive either upadacitinib or a placebo (dummy tablet).
Regular visits to a clinic for checks, blood tests, and questionnaires are required.
The study includes adults under 64 and teenagers aged 12 and over.
You can leave the study at any time if you change your mind.

Who may be eligible?

To join this study, you generally need to be an adult under 64 years old, or an adolescent aged 12 or older. You must have severe alopecia areata, meaning you have lost at least half of your scalp hair, and this hair loss hasn't gotten better on its own recently.

Your current episode of hair loss from alopecia areata should also have started less than eight years ago. This helps make sure the study focuses on more recent and active cases of severe alopecia areata.

There are also some reasons why you wouldn't be able to join. For example, if your hair loss is mainly a 'diffuse' type, or if you have other hair loss conditions like male or female pattern baldness, or certain skin conditions on your scalp, you wouldn't be able to take part. This is because these other conditions could make it harder for the researchers to clearly see how the study medicine affects alopecia areata.

Quick self-check

Are you an adult under 64, or a teenager aged 12 or older?
Do you have severe alopecia areata, with more than half of your scalp hair lost?
Has your current episode of alopecia areata started within the last 8 years?
Has your scalp hair not regrown naturally in the past 6 months?
Do you have other types of hair loss or scalp conditions that might interfere with the study?

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 a tablet by mouth once a day. You will either receive upadacitinib or a placebo (a dummy tablet). You might be in the study for a long time, potentially up to 160 weeks (about three years), with the possibility of changing your treatment group after 24 or 52 weeks. After you finish taking the study drug, you'll have a follow-up check for about a month.

You will need to attend regular visits at a hospital or clinic. These visits will involve various checks to see how you're doing. This includes medical checks, blood tests, looking for any side effects, and filling out questionnaires about your health and hair. Compared to your usual care, this study might involve more visits and assessments. The overall aim is to carefully monitor your progress and ensure your safety throughout the trial.

Potential risks and benefits

Participating in a clinical trial like this could offer the potential benefit of accessing a new treatment for severe alopecia areata that is not yet widely available. However, there are potential risks, as with any medicine. Side effects, while not fully known for alopecia areata in this drug, can occur and will be carefully monitored. You might also receive a placebo, meaning you wouldn't get the active medicine. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (269)

Total Skin and Beauty Dermatology Center /ID# 259539
Birmingham, United States· Active not recruiting
Duplicate_Advanced Research Associates - Glendale /ID# 259108
Glendale, United States· Completed
Southwest Skin Specialists /ID# 258234
Phoenix, United States· Completed
Alliance Dermatology and Mohs Center /ID# 258111
Phoenix, United States· Active not recruiting
Johnson Dermatology Clinic /ID# 259103
Fort Smith, United States· Active not recruiting
Duplicate_JOSEPH RAOOF MD,INC /ID# 258031
Encino, United States· Completed
First OC Dermatology /ID# 259220
Fountain Valley, United States· Recruiting
University of California Irvine /ID# 259096
Irvine, United States· Active not recruiting
Dermatology Research Associates /ID# 258033
Los Angeles, United States· Recruiting
Stanford University School of Medicine - Redwood City /ID# 259542
Redwood City, United States· Completed
Integrative Skin Science and Research /ID# 258114
Sacramento, United States· Recruiting
University of California Davis Health /ID# 258112
Sacramento, United States· Recruiting

+257 more sites — see the official record for the full list.

Common questions

What is alopecia areata?

Alopecia areata is a condition where your immune system attacks your hair follicles, causing hair to fall out, often in patches.

What is upadacitinib?

Upadacitinib is a medicine being tested to see if it can help with severe alopecia areata. It's already approved for other conditions.

Will I definitely get the medicine if I join?

No, there's a chance you might receive a placebo (dummy tablet) instead of the active medicine, especially at first.

How long will I be in the study?

You could be in the study for up to about three years, with regular visits and follow-up.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.

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.