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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661138
Recruitment Status : Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Upadacitinib Drug: Placebo for upadacitinib Drug: Topical Corticosteroids (TCS) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 27, 2018
Estimated Primary Completion Date : February 25, 2022
Estimated Study Completion Date : February 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids

Arm Intervention/treatment
Experimental: Arm A
Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
Drug: Upadacitinib
Upadacitinib is administered orally.
Other Name: ABT-494

Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.

Experimental: Arm B
Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
Drug: Upadacitinib
Upadacitinib is administered orally.
Other Name: ABT-494

Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.

Experimental: Arm C
Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
Drug: Upadacitinib
Upadacitinib is administered orally.
Other Name: ABT-494

Drug: Placebo for upadacitinib
Placebo is administered orally.

Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.

Experimental: Arm D
Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
Drug: Upadacitinib
Upadacitinib is administered orally.
Other Name: ABT-494

Drug: Placebo for upadacitinib
Placebo is administered orally.

Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661138


Locations
Show Show 43 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03661138    
Other Study ID Numbers: M17-377
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Upadacitinib
Topical Corticosteroids
Atopic Dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents