Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

This research is investigating a new way to treat moderate to severe eczema (atopic dermatitis) in teenagers and adults. The study, called a Phase 3 clinical trial, is testing a tablet medication called upadacitinib alongside steroid creams. Researchers want to understand if this combination is effective in reducing eczema symptoms and if it causes any side effects. Participants will be randomly given different doses of upadacitinib or a dummy pill (placebo) along with their steroid creams over a long period. The goal is to find better treatment options for people whose eczema hasn't responded well to other therapies.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

1,533

Start

09 Aug 2018

Estimated completion

23 Oct 2030

Atopic Dermatitis

Results

Results from this study

Posted March 2022

Results have been published for this study.

Primary outcome

Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Full results on the registry

What is this study about?

This study is designed to explore a new treatment approach for moderate to severe eczema, also known as atopic dermatitis. Eczema can be a very challenging condition, causing itchy, red, and inflamed skin, which can significantly impact daily life. For some people, standard treatments like creams and ointments aren't enough, and they might need stronger medications that affect the whole body.

This research is focusing on a medication called upadacitinib, which is given as a tablet. The study is particularly interested in seeing how well upadacitinib works when used together with topical corticosteroids, which are steroid creams often prescribed for eczema. By combining these treatments, doctors hope to achieve better control over eczema symptoms compared to using steroid creams alone or other existing treatments. This is a "Phase 3" study, meaning it's a large trial designed to confirm the effectiveness and safety of a treatment before it can be made widely available.

The main goal is to find out if this combination treatment can significantly improve eczema symptoms and reduce flare-ups, while also monitoring for any potential side effects. The study involves a large number of participants to ensure the results are reliable and can help inform future treatment guidelines for people living with moderate to severe eczema.

Key takeaways

This study is testing a new tablet for eczema (upadacitinib) with steroid creams.
It's for teenagers and adults with moderate to severe eczema.
Participation involves taking medication and having regular check-ups over a long period.
You might receive upadacitinib or a dummy pill (placebo) at first.
The goal is to find out if this combination treatment is effective and safe.
You can stop participating at any time if you wish.

Who may be eligible?

To be considered for this study, you generally need to be between 12 and 75 years old and have been diagnosed with eczema for at least three years.

Your eczema must be active and considered moderate to severe, meaning it covers a significant part of your body and causes a lot of itching. You should also have tried moisturizers regularly for at least a week before starting the study. It's important that previous eczema treatments, like other steroid creams or body-wide medications, haven't worked well enough for you.

There are also reasons you might not be able to join. For example, if you've ever taken a specific type of medication called a 'JAK inhibitor' before, or if you can't stop your current eczema treatments during the study. You also wouldn't be able to participate if you have other skin conditions that might make it hard to assess your eczema, or if you are pregnant, breastfeeding, or planning to become pregnant.

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 12 and 75 years old?
Have you had eczema for at least 3 years?
Is your eczema currently moderate to severe, itchy, and covering a noticeable area?
Have other eczema treatments (like strong creams or body-wide medications) not worked well enough for you?
Are you able and willing to stop your current eczema medications during the study?
Are you NOT pregnant, breastfeeding, or planning to become pregnant during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, it begins with a check-up period of about 35 days to make sure you meet all the requirements. After that, for the first 16 weeks, you won't know if you're receiving upadacitinib (at two different possible doses) or a dummy pill called a placebo. Everyone will also be using steroid creams.

After these 16 weeks, participants receiving the dummy pill will be switched to one of the upadacitinib doses. Everyone else will continue their original upadacitinib dose. This part of the study can go on for quite a long time – up to 260 weeks (about 5 years), and then for some, even longer, up to 524 weeks (about 10 years). You will have regular visits to the clinic for assessments and to check your health. At the very end of your participation, there will be a final check-up about a month after your last study medication.

Throughout the study, you'll be monitored closely. This includes checking your eczema symptoms, how you're feeling, and looking for any side effects from the medication. The total duration of your involvement could range from several months to many years, depending on which part of the study you participate in.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new and possibly effective treatment for your eczema that you wouldn't otherwise have access to. It also means your eczema will be closely monitored by medical professionals. However, there are potential risks, including side effects from the medication (upadacitinib) or the steroid creams. The long-term effects of upadacitinib are still being studied. You might also receive a placebo, meaning your eczema may not improve during the initial weeks. Even if you join, you are always free to withdraw from the study at any time for any reason, without it affecting your usual medical care.

Locations (193)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Total Skin and Beauty Derm Ctr /ID# 200548
Verified postcode
Birmingham, United States
Clinical Research Center AL /ID# 201865
Verified postcode
Birmingham, United States
ACCEL Research Sites /ID# 213364
Verified postcode
Birmingham, United States
Advanced Dermatology and Skin Care Centre /ID# 213550
Verified postcode
Mobile, United States
Alliance Dermatology and MOHs Center, PC /ID#200540
Verified postcode
Phoenix, United States
Arizona Research Center, Inc. /ID# 200546
Verified postcode
Phoenix, United States
Clear Dermatology & Aesthetics Center /ID# 201257
Verified postcode
Scottsdale, United States
University of Arizona /ID# 201059
Verified postcode
Tucson, United States
Bakersfield Derma & Skin Cance /ID# 200892
Verified postcode
Bakersfield, United States
Mosaic Dermatology /ID# 200553
Verified postcode
Beverly Hills, United States
University of California Irvine /ID# 200902
Verified postcode
Irvine, United States
Therapeutics Clinical Research /ID# 200593
Verified postcode
San Diego, United States

Common questions

What is upadacitinib?

Upadacitinib is a tablet medication being tested to treat moderate to severe eczema.

What are topical corticosteroids (TCS)?

TCS are steroid creams or ointments applied to the skin, commonly used to reduce eczema inflammation.

What does 'randomly assigned' mean?

It means a computer decides whether you get upadacitinib or a dummy pill, like flipping a coin, so the study is fair.

How long will the study last for me?

It could be from several months to many years, depending on which part of the study you're in.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, without affecting your regular medical care.