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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 160

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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