A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Conditions

Atopic Dermatitis

Keywords

Upadacitinib, Topical Corticosteroids, Atopic Dermatitis

Brief summary

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

Norito Katoh, Masanori Ikeda, Yukihiro Ohya, Hiroyuki Murota, Xiaofei Hu et al. (10 authors)

Dermatology and Therapy2023-12-2110 citations

10.1007/s13555-023-01071-2

Acne Among Japanese Patients with Atopic Dermatitis Receiving Upadacitinib in the Phase 3 Rising Up Study

Nobukazu Hayashi, Masanori Ikeda, John Liu, Eliza M. Raymundo, Yingyi Liu et al. (7 authors)

Dermatology and Therapy2023-06-258 citations

10.1007/s13555-023-00961-9

Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study

Norito Katoh, Yukihiro Ohya, Hiroyuki Murota, Masanori Ikeda, Xiaofei Hu et al. (11 authors)

Dermatology and Therapy2022-11-1929 citations

10.1007/s13555-022-00842-7

Growth analysis among adolescents with moderate-to-severe atopic dermatitis receiving upadacitinib in combination with topical corticosteroids in Japan: A case study series from a phase 3, randomized, controlled trial (Rising Up)

Toshiaki Tanaka, Takuya Sasaki, Kimitoshi Ikeda, Jianzhong Liu, Allan R. Tenorio et al. (6 authors)

World Allergy Organization Journal2022-09-017 citations

10.1016/j.waojou.2022.100678

Interventions

DRUGUpadacitinib

Upadacitinib is administered orally.

DRUGPlacebo for upadacitinib

Placebo is administered orally.

DRUGTopical Corticosteroids (TCS)

It is administered concomitantly with upadacitinib or placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

No

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

* 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. * Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants experiencing adverse events	Up to 141 Weeks	Adverse events are defined as those that began or worsened in severity after the first dose of study drug but within 30 days after the last dose of study drug.

Countries

Japan

Outcome results

None listed