Skip to main content
OpenTrials
Completed

NCT Number: NCT03661138

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ichinomiya Municipal Hospital /ID# 205942, Ichinomiya-shi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Upadacitinib

Drug

Upadacitinib is administered orally.

Other names: ABT-494

Placebo for upadacitinib

Drug

Placebo is administered orally.

Topical Corticosteroids (TCS)

Drug

It is administered concomitantly with upadacitinib or placebo.

Primary outcomes

  1. Number of participants experiencing adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: Rising Up

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2018
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.