AD Up

[M16-047] A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224016

Enrollment

Registered

2018-08-22

Start date

2018-10-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

investigational material(s) Generic name etc : ABT-494 / M16-047 INN of investigational material : Upadacitinib Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus - Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis

Exclusion criteria

Exclusion criteria: - Prior exposure to any Janus kinase (JAK) inhibitor - Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study - Requirement of prohibited medications during the study - Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions - Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Design outcomes

Primary

Measure	Time frame
efficacy - Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline at Week 16; - Proportion of subjects achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline at Week 16.	—

Secondary

Measure	Time frame
efficacy - Proportion of participants achieving an improvement (reduction) of 4 or more in worst pruritus Numerical Rating Scale (NRS) at week 16 - Proportion of participants achieving EASI 90 at week 16 - Proportion of subjects achieving EASI 75 at Week 4 - Proportion of subjects achieving EASI 100 at Week 16 in certain arms - Proportion of subjects achieving vIGA-AD of 0 at Week 16 in certain arms	—

Measure

Time frame

efficacy - Proportion of participants achieving an improvement (reduction) of 4 or more in worst pruritus Numerical Rating Scale (NRS) at week 16 - Proportion of participants achieving EASI 90 at week 16 - Proportion of subjects achieving EASI 75 at Week 4 - Proportion of subjects achieving EASI 100 at Week 16 in certain arms - Proportion of subjects achieving vIGA-AD of 0 at Week 16 in certain arms

—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactContact for Patients and HCP

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026