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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.

Must not have

Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Requirement of prohibited medications during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 16

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe skin itching and rash covering more than 10% of my body.

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I have had chronic eczema for over 3 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I do not need medications that are not allowed in the study.

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I have previously taken a JAK inhibitor medication.

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I don't have skin conditions that need systemic treatment or could affect atopic dermatitis assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 16

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

Pivotal Trial

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

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

~11250