Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Public ClinicalTrials.gov record NCT04345367. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04345367
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 727 participants
Conditions and interventions
Conditions
Interventions
- Abrocitinib 200 mg Drug
- Dupilumab 300 mg Combination Product
Drug · Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 11, 2020 (Actual)
- Primary completion
- Jul 13, 2021 (Actual)
- Completion
- Jul 13, 2021 (Actual)
- Last update posted
- Jul 8, 2022
2020 – 2021
United States locations
- U.S. sites
- 49
- U.S. states
- 21
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin & Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | — |
| Clinical Research Center Of Alabama | Birmingham | Alabama | 35209 | — |
| Alliance Dermatology & MOHS Center, PC | Phoenix | Arizona | 85032 | — |
| First OC Dermatology | Fountain Valley | California | 92708 | — |
| Ark Clinical Research | Long Beach | California | 90806 | — |
| Beach Allergy and Asthma Specialty Group, A Medical Corporation | Long Beach | California | 90808 | — |
| Wallace Medical Group, Inc | Los Angeles | California | 90056 | — |
| Empire Clinical Research | Pomona | California | 91767 | — |
| MedDerm Associates | San Diego | California | 92103 | — |
| University of California San Diego Dermatology | San Diego | California | 92122 | — |
| University Clinical Trials Inc. | San Diego | California | 92123 | — |
| Synergy Dermatology | San Francisco | California | 94132 | — |
| Wolverine Clinical Trials, Llc | Santa Ana | California | 92705 | — |
| Clinical Science Institute | Santa Monica | California | 90404 | — |
| Skin Care Research, LLC | Boca Raton | Florida | 33486 | — |
| Olympian Clinical Research | Largo | Florida | 33770 | — |
| Miami Dermatology & Laser Research, LLC | Miami | Florida | 33173 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| Accel Research Sites - Pure Skin Dermatology & Aesthetics | Orlando | Florida | 32819 | — |
| Clinical Research Trials of Florida, Inc. | Tampa | Florida | 33607 | — |
| Olympian Clinical Research | Tampa | Florida | 33614 | — |
| Integrated Clinical Research | West Palm Beach | Florida | 33406 | — |
| One Health Research Clinic | Norcross | Georgia | 30093 | — |
| Sneeze, Wheeze & Itch Associates, LLC | Normal | Illinois | 61761 | — |
| Dundee Dermatology | West Dundee | Illinois | 60118 | — |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | — |
| The South Bend Clinic Center for Research | South Bend | Indiana | 46617 | — |
| Epiphany Dermatology of Kansas, LLC | Overland Park | Kansas | 66215 | — |
| Avant Research Associates, LLC | Crowley | Louisiana | 70526 | — |
| MetroBoston Clinical Partners, LLC | Brighton | Massachusetts | 02135 | — |
| Onyx Clinical Research | Flint | Michigan | 48507 | — |
| Linden Road Imaging Center | Flint | Michigan | 48532 | — |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | — |
| Regional Medical Imaging, P.C. ( Local X-Ray) | Royal Oak | Michigan | 48067 | — |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | — |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | — |
| Vivida Dermatology | Las Vegas | Nevada | 89148 | — |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | — |
| Boice-Willis Clinic, PA | Rocky Mount | North Carolina | 27804 | — |
| Carolina Research Center, Inc. | Shelby | North Carolina | 28150 | — |
| Oregon Medical Research Center | Portland | Oregon | 97223 | — |
| Paddington Testing Co, Inc. | Philadelphia | Pennsylvania | 19103 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| International Clinical Research - Tennessee LLC | Murfreesboro | Tennessee | 37130 | — |
| Center for Clinical Studies, LTD. LLP | Houston | Texas | 77004 | — |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | — |
| Acclaim Dermatology, PLLC | Sugar Land | Texas | 77479 | — |
| Jordan Valley Dermatology Center | West Jordan | Utah | 84088 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 102 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04345367, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2022 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04345367 live on ClinicalTrials.gov.