← Back to Search

Monoclonal Antibodies

Upadacitinib vs Dupilumab for Eczema (Level 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
Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.
Eczema area and severity index (EASI) score ≥ 16; validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 16
Awards & highlights

Level Up Trial Summary

This trial is comparing 2 drugs to treat moderate to severe atopic dermatitis in adolescents and adults who have not responded to systemic therapy. Side effects and disease activity will be assessed.

Who is the study for?
Adolescents and adults aged 12-64 with moderate to severe atopic dermatitis (eczema) that hasn't improved with systemic treatments can join. They must have had symptoms for over 3 years, significant itching, and a certain amount of skin affected as measured by medical scales.Check my eligibility
What is being tested?
The trial is testing oral Upadacitinib against injectable Dupilumab in patients who haven't responded well to other treatments. It's a two-phase study lasting 32 weeks where participants are randomly assigned to one of the drugs and monitored through visits, blood tests, and questionnaires.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site for Dupilumab or gastrointestinal issues for Upadacitinib. Both drugs may also cause infections or allergic reactions due to their effect on the immune system.

Level Up Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had chronic eczema for over 3 years.
Select...
My eczema is severe, covering more than 10% of my body.
Select...
I have had chronic eczema for over 3 years.
Select...
My previous systemic treatment for my condition was not effective.
Select...
My eczema is severe, covering more than 10% of my body.
Select...
My eczema is severe, covering more than 10% of my body.

Level Up Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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
Eczema
Secondary outcome measures
Eczema
Eczema
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1
+2 more

Level Up Trial Design

2Treatment groups
Experimental Treatment
Group I: UpadacitinibExperimental Treatment1 Intervention
Participants will receive upadacitinib dose A daily in period 1. Eligible participants will receive upadacitinib dose B daily in period 2.
Group II: Dupilumab followed by UpadacitinibExperimental Treatment2 Interventions
Participants will receive dupilumab as per its label in period 1. Eligible participants will receive upadacitinib dose A in period 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~9670
Dupilumab
2017
Completed Phase 4
~12230

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
947 Previous Clinical Trials
495,712 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
388 Previous Clinical Trials
140,393 Total Patients Enrolled

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05601882 — Phase 3
Atopic Dermatitis Research Study Groups: Upadacitinib, Dupilumab followed by Upadacitinib
Atopic Dermatitis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05601882 — Phase 3
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05601882 — Phase 3
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT05601882 — 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 project accept volunteers who are younger than 65 years old?

"To be eligible for this trial, patients must between 12 and 64 years old."

Answered by AI

What is the latest regulatory decision on Upadacitinib?

"There is evidence from past clinical trials to support the safety of Upadacitinib, which receives a score of 3."

Answered by AI

Is this study taking place at several locations across North America?

"This trial is being conducted at 64 sites around the world, including California Dermatology Institute /ID# 250213 in Thousand Oaks, DermAssociates-Rockville /ID# 250047 in Rockville, and Burke Pharmaceutical Research /ID# 249838 in Hot Springs."

Answered by AI

Are people still able to sign up for this research project?

"No, this study is not currently looking for patients. As seen on clinicaltrials.gov, the most recent update to this trial was on November 14th, 2022 and it was first posted January 24th, 2023. Although this particular trial isn't searching for candidates, there are 257 other trials with open recruitment at present."

Answered by AI

Who meets the eligibility requirements for participating in this research project?

"This dermatitis clinical trial, which needs to enroll 880 total participants, is currently looking for patients that suffer from the skin condition and are between 12 and 64 years old."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
What site did they apply to?
Dermatology Research Associates /ID# 249829
Precision Clinical Research /ID# 250990

Why did patients apply to this trial?

I tried different drugs but didnt work,.
PatientReceived 2+ prior treatments
~377 spots leftby Mar 2025