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Open-Label Extension Study of Upadacitinib in 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. Identifier: NCT04195698
Recruitment Status : Active, not recruiting
First Posted : December 12, 2019
Last Update Posted : September 2, 2021
Information provided by (Responsible Party):

Brief Summary:

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Upadacitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 485 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : March 2, 2023
Estimated Study Completion Date : March 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Upadacitinib
Participants will be administered with upadacitinib once daily (QD)
Drug: Upadacitinib
Upadacitinib will be administered oral as tablet
Other Names:
  • ABT-494

Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: From Baseline to 30 days following last dose of study drug (Week 52) ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.
  • Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.

Exclusion Criteria:

  • Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
  • 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 identifier (NCT number): NCT04195698

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Sponsors and Collaborators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
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Responsible Party: AbbVie Identifier: NCT04195698    
Other Study ID Numbers: M19-850
2019-001227-12 ( EudraCT Number )
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021
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)
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.

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