Upadacitinib for Eczema
(Measure Up 1 Trial)

Recruiting in Palo Alto (17 mi)

+184 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Eligibility Criteria

This trial is for adolescents and adults with moderate to severe atopic dermatitis (eczema) who weigh at least 40 kg, have a history of inadequate response to certain topical treatments, and are candidates for systemic therapy. Participants should not be pregnant or breastfeeding, must discontinue other eczema treatments before the study, and cannot have used JAK inhibitors previously.

Inclusion Criteria

I have used a moisturizer twice a day for at least a week.

Your eczema is very severe, with a score of 16 or higher on a special scale.

Your skin condition is rated as moderate or worse by the study doctor at the screening and baseline visits.

+11 more

Exclusion Criteria

I do not have active skin diseases or infections that need systemic treatment.

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

I cannot or do not want to stop my current skin treatment before the study.

+2 more

Participant Groups

The trial is testing Upadacitinib's effectiveness in treating moderate to severe eczema compared to a placebo. It aims to see if this drug can improve symptoms in those who haven't responded well enough to topical therapies.

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.

Upadacitinib is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Rinvoq for: