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Janus Kinase (JAK) Inhibitor

Upadacitinib for Eczema

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA) affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score ≥ 4.
Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

Study Summary

This trial will test if upadacitinib is an effective and safe treatment for moderate to severe atopic dermatitis in adolescents and adults.

Who is the study for?
This trial is for adolescents and adults with moderate to severe atopic dermatitis (eczema) who haven't responded well to topical treatments or need systemic therapy. Participants should have a body weight of at least 40 kg if they are between 12 and under 18 years old, and not be pregnant, breastfeeding, or planning pregnancy.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of Upadacitinib compared to a placebo in treating atopic dermatitis. It's designed for those who require more than just skin creams or ointments due to the severity of their condition.See study design
What are the potential side effects?
Potential side effects may include common cold symptoms, nausea, headaches, and potential increased risk of infection. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eczema is severe, covering more than 10% of my body and itches intensely.
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I am between 12 and 18 years old and weigh at least 40 kg.
Select...
I have had chronic eczema for over 3 years.
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My eczema is severe, covering more than 10% of my body and itches intensely.
Select...
I've tried topical treatments for my skin condition without success or cannot use them due to side effects.
Select...
I have had chronic eczema for over 3 years.
Select...
I need or recently needed medication for my entire body to treat my disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16
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
Secondary outcome measures
Adolescents: Percent Change From Baseline in EASI Score at Week 16
Adolescents: Percent Change From Baseline in SCORAD Score at Week 16
Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16
+41 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343
6%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Upadacitinib 30 mg QDExperimental Treatment1 Intervention
Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.
Group II: Upadacitinib 15 mg QDExperimental Treatment1 Intervention
Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.
Group III: Placebo / UpadacitinibPlacebo Group2 Interventions
Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~9690

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
945 Previous Clinical Trials
495,491 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
140,244 Total Patients Enrolled

Media Library

Upadacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03607422 — Phase 3
Atopic Dermatitis Research Study Groups: Placebo / Upadacitinib, Upadacitinib 15 mg QD, Upadacitinib 30 mg QD
Atopic Dermatitis Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT03607422 — Phase 3
Upadacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03607422 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve participants who are above the age of 65?

"The age limit for participants in this trial are 12 years or older but must be younger than 75."

Answered by AI

Can you tell me if there is a body of research surrounding Upadacitinib?

"Upadacitinib is being studied in 21 different clinical trials at the moment, 14 of which are Phase 3. The global distribution of these studies suggests that Upadacitinib could be a promising treatment, with 3924 locations running trials for this medication."

Answered by AI

Is this research project being conducted in a few hospitals or many hospitals across the state?

"Enrolling patients at 92 different locations, this study is presently underway. Some of these sites are based in Towson, Chicago and Ann Arbor with the remaining 89 clinical trial centres located throughout the United States. If you enroll in this study, it is important to choose a location close to your home to reduce travel burden."

Answered by AI

What is the originality of this research?

"Upadacitinib has undergone 21 clinical trials in the 5 years since its initial study in 2015. These trials have taken place across 953 cities and 54 countries, with 1629 patients participating in the first Phase 3 trial sponsored by AbbVie."

Answered by AI

What possible side effects could Upadacitinib have on patients?

"Upadacitinib has received a safety score of 3. This is due to the fact that it is a Phase 3 trial, meaning there is clinical evidence supporting its efficacy as well as numerous rounds of data affirming its safety."

Answered by AI

Are patients currently being accepted into this trial program?

"As of right now, this study has finished recruiting patients. The information posted on clinicaltrials.gov suggests that the trial was first announced on 7/27/2018 and experienced its most recent edit on 3/1/2022. If you are interested in other studies, know that there are 257 trials for eczema and 21 for Upadacitinib currently underway."

Answered by AI

What medical conditions has Upadacitinib been proven to improve?

"Upadacitinib is useful for patients that may require systemic therapy, as well as those dealing with rheumatoid arthritis, methotrexate treatment, and an insufficient response to conventional therapies."

Answered by AI

How many people are enrolled in this experiment?

"This study is no longer recruiting patients. The initial posting was on July 27th, 2018 and the most recent update was March 1st, 2022. For those still seeking trials, there are 257 clinical trials for eczema actively enrolling patients and 21 trials for Upadacitinib."

Answered by AI

What are researchers hoping to learn from this clinical trial?

"The primary goal of this study, which will be assessed at Week 16, is to determine the percentage of participants who achieve a 75% reduction in eczema severity (as measured by the Eczema Area and Severity Index). Secondary objectives include assessing the percentage of participants who experience an improvement in ADerm-IS emotional state score (defined as a score ≥11 on the MCID scale) from baseline, adolescents: percent change from baseline in SCORAD score at Week 16, and percentage of participants achieving an improvement in Atopic dermatitis Symptom Scale 7-item total symptom score (TSS-7"

Answered by AI

How can I apply to participate in this research?

"This study is looking for 912 participants that have eczema, are infantile, and between the ages of 12-75. Key inclusion criteria are as follows: must weigh ≥40kg if under 18 years old, have chronic atopic dermatitis that has shown symptoms for 3+ years & meets Hanifin & Rajka criteria, active moderate to severe AD defined by Eczema Area & Severity Index (EASI) ≥ 16 or validated Investigator's Global Assessment (vIGA) ≥ 3, BSA affected by AD ≥ 10%, and weekly average of daily Worst Pruritus NRS score ≥ 4., be"

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Alabama
How old are they?
18 - 65
What site did they apply to?
Total Skin and Beauty Derm Ctr /ID# 205129
Keck School of Medicine of USC /ID# 206971
Allergy, Asthma & Immunology Associates, PC /ID# 218169
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

What questions have other patients asked about this trial?

How long is a screening visit?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I've suffered my whole life with Eczema, nothing works!
PatientReceived 2+ prior treatments
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~137 spots leftby Mar 2025