Upadacitinib for Eczema

Recruiting in Palo Alto (17 mi)

+203 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?

This trial is testing upadacitinib, an oral medication, to see if it can help people with severe eczema. The medication works by calming down the overactive immune system to reduce skin inflammation and itching. Upadacitinib is approved in many countries for the treatment of atopic dermatitis in individuals whose disease is not adequately controlled with other treatments or when those treatments are not suitable.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

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

I am between 12 and 18 years old and weigh at least 40 kg.

I have had chronic eczema for over 3 years.

See 3 more

Exclusion Criteria

I have previously taken medication that targets Janus kinase (JAK).

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

I do not have skin conditions or infections that need strong medication or could affect skin assessments.

See 2 more

Treatment Details

Interventions

Placebo for Upadacitinib (Drug)
Upadacitinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe 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.

Participant Groups

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 Canada for the following indications: