A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up)
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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: NCT03738397 |
Recruitment Status :
Completed
First Posted : November 13, 2018
Last Update Posted : January 13, 2021
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Condition or disease | Intervention/treatment | Phase |
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Atopic Dermatitis | Drug: Upadacitinib (ABT-494) Drug: Dupilumab Drug: Placebo | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 689 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis |
Actual Study Start Date : | February 21, 2019 |
Actual Primary Completion Date : | August 27, 2020 |
Actual Study Completion Date : | December 9, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Participants administered with upadacitinib
Participants are administered with upadacitinib from baseline to week 24 and placebo pre-filled syringe at baseline visit (2 injections) followed by an injection every other week until week 22
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Drug: Upadacitinib (ABT-494)
Oral; Tablet
Other Names:
Drug: Placebo Placebo pre-filled syringe is as administered subcutaneous (SC) injections |
Experimental: Participants administered with dupilumab
Participants are administered with dupilumab (2 injections) at baseline followed by one every other week until week 22 and placebo tablets daily from baseline to week 24
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Drug: Dupilumab
Dupilumab is administered as a subcutaneous (SC) injection Drug: Placebo Oral; Tablet |
- Percentage of participants achieving a 75% reduction in Eczema Area and Severity Index (EASI) (EASI 75) from Baseline [ Time Frame: At Week 16 ]The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
- Percent change in worst pruritus numerical rating scale (NRS) [ Time Frame: From Baseline (Week 0) to Week 16 ]The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
- Percentage of participants achieving a 100% reduction in EASI (EASI 100) [ Time Frame: At Week 16 ]The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
- Percentage of participants achieving a 90% reduction in EASI (EASI 90) [ Time Frame: At Week 16 ]The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
- Percent change in worst pruritus NRS [ Time Frame: From Baseline (Week 0) to Week 4 ]The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
- Percentage of participants achieving a 75% reduction in EASI (EASI 75) [ Time Frame: At Week 2 ]The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
- Percent change in worst pruritus NRS [ Time Frame: From Baseline (Week 0) to Week 1 ]The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.

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.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface Area (BSA) and pruritus.
- Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.
Exclusion Criteria:
- Participant has prior exposure to Janus Kinase (JAK) inhibitor.
- Participant has prior exposure to dupilumab.
- Participant is unable or unwilling to discontinue current AD treatments prior to the study.
- Participant has requirement of prohibited medications during the study.
- Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
- Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

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): NCT03738397

Study Director: | AbbVie Inc. | AbbVie |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT03738397 |
Other Study ID Numbers: |
M16-046 2018-002264-57 ( EudraCT Number ) |
First Posted: | November 13, 2018 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | January 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. |
URL: | https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html |
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 |
Upadacitinib ABT-494 Dupilumab Atopic Dermatitis |
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 |