Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
NCT04345367
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 18 years of age or older
- Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
- Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
- Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease
- Acute or chronic medical or laboratory abnormality that may increase the risk
associated with study participation
- Have increased risk of developing venous thromboembolism
- Unwilling to discontinue current AD medications prior to the study or require
treatment with prohibited medications during the study
- Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including
dupilumab, lebrikizumab or tralokinumab
- Other active non-AD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,
malignancies, current or history of certain infections, lymphoproliferative disorders
and other medical conditions at the discretion of the investigator
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling
to use contraception
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Anaheim, California
- Birmingham, Alabama
- Lancaster, California
- Long Beach, California
- San Diego, California
- Farmington, Connecticut
- Delray Beach, Florida
- Hollywood, Florida
- Miami, Florida
- Sarasota, Florida
- Sunrise, Florida
- West Dundee, Illinois
- Evansville, Indiana
- Evansville, Indiana
- Lexington, Kentucky
- Ypsilanti, Michigan
- Kirksville, Missouri
- Bexley, Ohio
- Norman, Oklahoma
- Rapid City, South Dakota
- Memphis, Tennessee
- Houston, Texas
- Morgantown, West Virginia
- Markham, Ontario
- Peterborough, Ontario
- Chicago, Illinois
- Charleston, South Carolina
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy | ||||
Official Title ICMJE | A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS | ||||
Brief Summary | This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||
Condition ICMJE | Atopic Dermatitis | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE |
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE | 724 | ||||
Original Estimated Enrollment ICMJE | 600 | ||||
Estimated Study Completion Date ICMJE | July 14, 2021 | ||||
Estimated Primary Completion Date | July 14, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Bulgaria, Canada, Chile, Finland, Germany, Hungary, Italy, Korea, Republic of, Latvia, Poland, Slovakia, Spain, Taiwan, United States | ||||
Removed Location Countries | Belgium, Czechia | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT04345367 | ||||
Other Study ID Numbers ICMJE | B7451050 2019-004013-13 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
| ||||
PRS Account | Pfizer | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |