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A Study of Upadacitinib for Adults with Moderate to Severe Atopic Dermatitis Who Did Not Respond Well Enough to Dupilumab Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Atopic Dermatitis in adults, which is a long-term skin condition that causes red, itchy, and inflamed skin. The study will include people who have moderate to severe atopic dermatitis and have not responded well enough to treatment with dupilumab, a medication they have been using for at least four months. The study will test a different medication called upadacitinib (also known by its code name ABT-494) to see if it works better for these patients. Upadacitinib will be given as a tablet taken by mouth, while dupilumab is given as an injection under the skin.

The purpose of this study is to compare how well upadacitinib works compared to dupilumab in treating the symptoms of atopic dermatitis in people who did not have good results with dupilumab. The study will measure how much the skin condition improves and how much the itching decreases. Participants will need to have certain levels of disease activity at the start, including a specific score that measures the extent and severity of their eczema, a score that shows how much of their body is affected by the skin condition, and a score that measures how bad their itching is. They will also need to have been using dupilumab according to its approved instructions but still have symptoms that are not well controlled.

During the study, participants will receive either upadacitinib or dupilumab for a treatment period of up to 32 weeks. They will need to continue using a basic skin moisturizer twice daily throughout the study. The main measure of success will be checked at week 8 to see how many people have at least a 90 percent reduction in their eczema symptoms. The study will also look at how many people have their itching reduced to very low levels and how quickly these improvements happen. Throughout the study, the safety of the treatments will be carefully monitored.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline visit and treatment start
At the baseline visit, your disease activity will be assessed. This includes measuring the severity and extent of your skin condition using specific scales.
Your Eczema Area and Severity Index score will be recorded, which measures how much of your skin is affected and how severe the condition is.
Your Investigator's Global Assessment score will be determined, which is an overall rating of your skin condition severity.
The percentage of your body surface area affected by the condition will be measured.
You will be asked to rate your worst itching on a scale from 0 to 10 using the Worst Pruritus Numerical Rating Scale. This rating is based on the average of daily scores from the 7 days before this visit.
You will be assigned to receive either upadacitinib or dupilumab as your treatment medication.
You will continue applying a topical emollient (moisturizer) twice daily throughout the study, as you have been doing for at least 7 days before this visit.
Step 2
Treatment period with assigned medication
If you are assigned to receive upadacitinib, you will take it as a modified-release tablet by mouth.
If you are assigned to receive dupilumab, you will receive it as a subcutaneous injection, which means it will be injected under your skin.
The specific dosage, frequency, and exact administration schedule will be provided by the study staff according to the treatment protocol.
You will continue to apply your moisturizer twice daily as instructed.
You will continue to record your daily worst itching score throughout the treatment period.
Step 3
Week 4 assessment
At week 4, your condition will be assessed.
Your worst itching score will be evaluated to determine if it has improved to 0 or 1 on the scale.
You will continue your assigned treatment and daily moisturizer application.
Step 4
Week 8 assessment
At week 8, a comprehensive assessment of your condition will be performed.
Your Eczema Area and Severity Index will be measured to determine if there has been at least a 90% improvement from the baseline visit.
Your worst itching score will be assessed to see if it has reached 0 or 1 on the scale.
The study staff will evaluate whether you have achieved both the skin improvement and itching reduction goals simultaneously.
Step 5
Continued treatment and follow-up
You will continue your assigned treatment beyond week 8 as directed by the study protocol.
Regular assessments will continue to monitor the effectiveness and safety of your treatment.
You will maintain twice-daily application of your moisturizer throughout the entire study period.
The study is expected to continue until approximately June 2027.

Who can join the trial?

11 criteria

You must have atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin
You must be an adult, meaning 18 years of age or older
You must be either male or female
You must have an EASI score of 12 or higher at the start of the study. EASI is a scoring system that measures how severe your skin rash is and how much of your body is affected
You must have a vIGA-AD score of 3 or higher at the start of the study. This is a scale that doctors use to rate how severe your skin condition appears overall
You must have 10% or more of your body surface area affected by the skin condition
You must have an average itch score of 4 or higher based on daily ratings over 7 days before starting the study. You need to have recorded at least 4 out of 7 daily scores
You must have been taking dupilumab, which is a medicine used to treat atopic dermatitis, for at least 4 months and it has not worked well enough for you
You must have been applying a moisturizer twice daily for at least 7 days before the study starts and agree to continue this throughout the study
You must have had chronic atopic dermatitis, meaning long-lasting symptoms that started at least 3 years before joining the study
Your condition must meet specific medical criteria called Hanifin and Rajka criteria, which are standards doctors use to confirm atopic dermatitis diagnosis

Who cannot join the trial?

4 criteria

The study did not provide specific exclusion criteria, which are the reasons why some patients cannot take part in the research.
If you are interested in participating, a doctor will need to review your full medical history and current health condition to determine if this study is appropriate for you.
Generally, clinical trials may exclude patients based on factors such as other medical conditions, certain medications they are taking, pregnancy or breastfeeding, or previous treatments that did not work.
Since the specific reasons for not being able to join this study are not listed in the available information, a healthcare professional conducting the trial will assess your individual situation.

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Verified sites

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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
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Hospital General Universitario De Valencia
Valencia, Spain

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Investigated drugs

Upadacitinib
is a medicine used to treat moderate to severe atopic dermatitis, which is a skin condition that causes itchy and inflamed skin. This medication works by blocking certain proteins in the body that cause inflammation. In this study, it is being tested to see if it can help patients who have not responded well enough to another treatment.
Dupilumab
is another medicine used to treat moderate to severe atopic dermatitis. It works by blocking certain proteins that cause inflammation and itching in the skin. In this study, it is being used as a comparison treatment to see how well upadacitinib works in patients who have not had enough improvement with dupilumab.

What is already known about the treatment

Upadacitinib
Upadacitinib is an oral medication taken by mouth in tablet form that is used to treat moderate to severe atopic dermatitis (a chronic skin condition causing itchy, inflamed skin) in adults who have not responded well to other treatments. It works by blocking a specific enzyme called Janus kinase (JAK), which plays a key role in the immune system's inflammatory response, thereby reducing skin inflammation and itching. This medication belongs to a class of drugs known as JAK inhibitors and is currently approved and used in clinical practice for various inflammatory conditions. In this clinical trial, researchers are comparing its effectiveness and safety against another approved medication called dupilumab in patients who did not achieve adequate improvement with dupilumab treatment.
Dupilumab
Dupilumab is an injectable medication administered under the skin that is used to treat moderate to severe atopic dermatitis in adults and children who need systemic therapy. It works by blocking two proteins called interleukin-4 and interleukin-13, which are key drivers of the inflammatory process that causes the symptoms of atopic dermatitis, such as itching and skin rashes. This medication belongs to a class of drugs called monoclonal antibodies and is well-established in medical practice as an effective treatment for atopic dermatitis and other allergic conditions. In this study, it serves as the comparison treatment to evaluate how well upadacitinib works in patients who have not responded adequately to dupilumab therapy.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition that causes red, itchy, and dry patches on the skin. The disease typically begins in childhood but can occur at any age, often running in families with a history of allergies or asthma. The affected skin becomes very itchy, and scratching can lead to further irritation, thickening of the skin, and sometimes infections. The condition tends to flare up periodically, with symptoms worsening during certain times and improving during others. Common areas affected include the face, hands, feet, inner elbows, and behind the knees. The severity of symptoms can vary widely from person to person, ranging from mild dryness to severe, widespread rashes that significantly impact daily activities.