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Monoclonal Antibodies

Upadacitinib vs Dupilumab for Eczema (Start Up Trial)

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Baseline weekly average of daily Worst Itch Scale (WIS) or Worst Scratch/Itch numerical rating scale (WSI-NRS) ≥ 4
≥ 10% Body Surface Area of AD involvement at the Baseline Visit
Must not have
Known history of retinal detachment, previous cataract surgery, previous significant ocular trauma, or a known congenital ocular abnormality
Diagnosed active parasitic infection or suspected/high risk of parasitic infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 160
Awards & highlights

Summary

This trial compares two drugs, upadacitinib and dupilumab, in children with moderate to severe atopic dermatitis who need systemic treatment. Participants will be given either upadac

Who is the study for?
Children aged 2 to less than 12 with moderate to severe atopic dermatitis (eczema) who haven't responded well to topical treatments or for whom systemic therapy is advised. They must weigh at least 10 kg and meet certain criteria for disease severity, including an EASI score ≥16 and itchiness rating ≥4. Children previously treated with dupilumab without success or those unable to use it due to allergies can join.
What is being tested?
The trial compares oral upadacitinib taken daily against subcutaneous dupilumab injections every few weeks in children with eczema. It aims to assess side effects and how the disease responds over time, involving regular hospital visits, clinical assessments, blood tests, and questionnaires.
What are the potential side effects?
Potential side effects may include reactions where the medicine enters the body, changes in liver enzymes seen in blood tests indicating liver impact, gastrointestinal symptoms like stomach pain or bowel movement changes, skin issues such as rashes or itching beyond their usual eczema symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My worst daily itch is rated 4 or higher on a scale.
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At least 10% of my skin is affected by my condition.
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My weight and height are above the 5th percentile for my age.
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I've had poor responses to two steroid treatments over 14 days in the last 6 months.
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I have used dupilumab before without any issues or poor response.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of serious eye problems or surgeries.
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I have or might have a parasitic infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 160
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 160 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving a 75% Reduction from Baseline in Eczema Area and Severity Index Score (EASI 75)
Secondary study objectives
Percent change in Scoring Atopic Dermatitis (SCORAD) from Baseline
Percentage of participants achieving Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points
Percentage of participants achieving a 50% reduction from Baseline in EASI score (EASI 50)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Randomized CohortExperimental Treatment2 Interventions
Participants in the Randomized Cohort will be randomized to receive either medium dose upadacitinib daily adult equivalent dose, low dose upadacitinib daily adult equivalent dose or dupilumab every 2 weeks or 4 weeks (at the label-indicated dose and frequency).
Group II: Dupi-IR CohortExperimental Treatment1 Intervention
Participants in this cohort will receive upadacitinib medium dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960
Upadacitinib
2014
Completed Phase 3
~9710

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,103 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
155,423 Total Patients Enrolled
~450 spots leftby Aug 2027
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