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Janus Kinase (JAK) Inhibitor

Upadacitinib for Eczema

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 AD defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA) affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score ≥ 4.

Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Study Summary

This trial will test if upadacitinib is an effective and safe treatment for moderate to severe atopic dermatitis in adolescents and adults.

Who is the study for?

This trial is for adolescents and adults with moderate to severe atopic dermatitis (eczema) who haven't responded well to topical treatments or need systemic therapy. Participants should have a body weight of at least 40 kg if they are between 12 and under 18 years old, and not be pregnant, breastfeeding, or planning pregnancy.Check my eligibility

What is being tested?

The study is testing the effectiveness and safety of Upadacitinib compared to a placebo in treating atopic dermatitis. It's designed for those who require more than just skin creams or ointments due to the severity of their condition.See study design

What are the potential side effects?

Potential side effects may include common cold symptoms, nausea, headaches, and potential increased risk of infection. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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My eczema is severe, covering more than 10% of my body and itches intensely.

Select...

I have had chronic eczema for over 3 years.

Select...

My eczema is severe, covering more than 10% of my body and itches intensely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, 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

Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16

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 SCORAD Score at Week 16

Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16

+41 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343

URINARY TRACT INFECTION

UPPER RESPIRATORY TRACT INFECTION

NASOPHARYNGITIS

HYPERTENSION

100%

80%

60%

40%

20%

Study treatment Arm

Abatacept

Upadacitinib 15 mg

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Upadacitinib 30 mg QDExperimental Treatment1 Intervention

Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.

Group II: Upadacitinib 15 mg QDExperimental Treatment1 Intervention

Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.

Group III: Placebo / UpadacitinibPlacebo Group2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~9670

0 / 3Eligibility criteria met