Rising Up

A Phase 3 Randomized, Multicenter, Double-Blind Study to Evaluate the Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects in Japan With Moderate to Severe Atopic Dermatitis [M17-377]

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224059

Enrollment

264

Registered

2018-09-14

Start date

2018-11-17

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 / M17-377 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. -Able to tolerate topical corticosteroids for atopic dermatitis lesions.

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
safety Number of participants experiencing adverse events	—

Secondary

Measure	Time frame
safety -	—

Countries

Japan

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