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Corticosteroid

Upadacitinib + Topical Corticosteroids for Eczema (AD Up Trial)

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 atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4
Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 16
Awards & highlights

AD Up Trial Summary

This trial is testing a new drug to see if it's effective and safe for treating moderate to severe atopic dermatitis in adolescents and adults.

Who is the study for?
Adolescents and adults with moderate to severe atopic dermatitis (eczema) who haven't responded well to standard creams or need systemic treatment. Participants should have a significant area of skin affected, intense itchiness, and a history of the condition for at least 3 years. They must weigh over 40 kg if under 18. Not eligible if they've used JAK inhibitors before, can't stop current eczema treatments, have other major skin conditions/infections, or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial is testing Upadacitinib pills combined with topical corticosteroids against placebo pills with topical corticosteroids in people with stubborn eczema to see which is better at reducing symptoms like redness and itching.See study design
What are the potential side effects?
Upadacitinib may cause side effects such as colds or upper respiratory infections, headaches, nausea, acne and increased blood cholesterol levels. Topical steroids might thin the skin or cause local irritation.

AD Up Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe skin itching and rash covering more than 10% of my body.
Select...
I have had chronic eczema for over 3 years.

AD Up Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 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
Dermatitis, Atopic
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 Worst Pruritus NRS at Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1
+19 more

AD Up Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Upadacitinib 30 mg QD + Topical CorticosteroidsExperimental Treatment2 Interventions
Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Group II: Upadacitinib 15 mg QD + Topical CorticosteroidsExperimental Treatment2 Interventions
Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Group III: Long-Term ExtensionExperimental Treatment2 Interventions
Participants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524.
Group IV: Placebo / Upadacitinib + Topical CorticosteroidsPlacebo Group3 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. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical corticosteroids (TCS)
2020
Completed Phase 3
~110
Upadacitinib
2014
Completed Phase 3
~9670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
499,605 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
144,439 Total Patients Enrolled

Media Library

Topical corticosteroids (TCS) (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03568318 — Phase 3
Atopic Dermatitis Research Study Groups: Long-Term Extension, Placebo / Upadacitinib + Topical Corticosteroids, Upadacitinib 15 mg QD + Topical Corticosteroids, Upadacitinib 30 mg QD + Topical Corticosteroids
Atopic Dermatitis Clinical Trial 2023: Topical corticosteroids (TCS) Highlights & Side Effects. Trial Name: NCT03568318 — Phase 3
Topical corticosteroids (TCS) (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03568318 — Phase 3
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT03568318 — Phase 3

Frequently Asked Questions

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

Are patients currently being accepted into this trial?

"This study is no longer admitting participants. It was originally posted on 8/9/2018 and last updated on 3/8/2022. However, there are presently 257 studies actively admitting participants with eczema and 21 studies for Topical corticosteroids (TCS) looking for patients."

Answered by AI

Are there other research facilities in this town that are also testing this treatment?

"Currently, this study is being conducted out of the Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403 in Québec, Quebec, Tory P Sullivan, MD PA /ID# 201174 in North Miami Beach, Florida, and Clinical Research of West Florida, Inc /ID# 203643 in Clearwater. An additional 75 research sites are located throughout the country."

Answered by AI

Are octogenarians able to enroll in this program?

"The age range for this clinical trial is 12 to 75. There are 118 studies specifically designed for children and 200 trials available for seniors."

Answered by AI

Does this trial break new ground in the medical community?

"Since 2015, medical researchers have been studying the efficacy of Topical corticosteroids (TCS). In 2015, 1629 patients were involved in a study sponsored by AbbVie. After this initial research was conducted, Topical corticosteroids (TCS) received Phase 3 drug approval. As of now, 21 live studies are being conducted for Topical corticosteroids (TCS), spanning 953 cities and 54 countries."

Answered by AI

What are the aims of this clinical research?

"The primary outcome of this trial is the percentage of participants achieving a validated investigator global assessment for atopic dermatitis (vIGA-AD) of 0 or 1 with a reduction from baseline of ≥ 2 points at week 16. Secondary outcomes include adolescents: percentage of participants achieving an EASI 75 response at week 2, which is defined as 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"

Answered by AI

Could I be a subject of this research?

"This medical trial is looking for 968 participants between the ages of 12 and 75 who have eczema. In order to be eligible, participants must also meet the following criteria: They must have a documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR systemic treatment for AD within 6 months prior to Baseline Visit, Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age, Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria., Active"

Answered by AI

Are there any harmful side effects associated with using TCS?

"Corticosteroids that are applied topically have shown efficacy in Phase 3 trials and multiple rounds of data support its safety, so it received a score of 3."

Answered by AI

What skin conditions are helped by the use of Topical corticosteroids (TCS)?

"Topical corticosteroids (TCS) are most often used on patients that may require systemic therapy. Additionally, this medication can help those suffering from rheumatoid arthritis, methotrexate, and other issues not responding well to conventional treatment plans."

Answered by AI

How many people are enrolled in this trial at most?

"Currently, this trial is not looking for new patients. However, there are 257 other clinical trials involving eczema and 21 studies concerning Topical corticosteroids (TCS) that are still recruiting participants."

Answered by AI

What other scientific papers exist on the topic of Topical corticosteroids (TCS)?

"At the moment, there are 21 different clinical trials underway that focus on Topical corticosteroids (TCS). Of those, 14 have progressed to Phase 3. Although a majority of these studies originate in Belgrade, Beograd, one can find 3924 locations running similar research worldwide."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
What site did they apply to?
DuPage Medical Group /ID# 202065
Center for Clinical Studies /ID# 200582

Why did patients apply to this trial?

I would like help. Never mind. You ask to many questions. Do not use my info.
PatientReceived no prior treatments
~225 spots leftby Apr 2025