Upadacitinib + Topical Corticosteroids for Eczema
(AD Up Trial)

Recruiting in Palo Alto (17 mi)

+196 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

Trial Summary

What is the purpose of this trial?

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

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

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

I've tried creams or pills for my skin condition without success.

I have had chronic eczema for over 3 years.

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Exclusion Criteria

I cannot or do not want to stop my current eczema treatments before the study.

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

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

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Treatment Details

Interventions

Topical corticosteroids (TCS) (Corticosteroid)
Upadacitinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.