A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Public ClinicalTrials.gov record NCT05601882. 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/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment Period 1 and a 16-week treatment Period 2. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05601882
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 920 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 64 Years
- 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
- Nov 28, 2022 (Actual)
- Primary completion
- Mar 19, 2024 (Actual)
- Completion
- Aug 8, 2024 (Actual)
- Last update posted
- Feb 14, 2025
2022 – 2024
United States locations
- U.S. sites
- 58
- U.S. states
- 23
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Dermatology Specialists /ID# 250212 | Phoenix | Arizona | 85006 | — |
| Alliance Dermatology and Mohs Center /ID# 249671 | Phoenix | Arizona | 85032 | — |
| Clinical Trials Institute - Northwest Arkansas /ID# 249838 | Fayetteville | Arkansas | 72703 | — |
| Arkansas Research Trials /ID# 250722 | North Little Rock | Arkansas | 72217 | — |
| Joseph Raoof Md,Inc /Id# 250211 | Encino | California | 91436 | — |
| First OC Dermatology /ID# 250686 | Fountain Valley | California | 92708 | — |
| Antelope Valley Clinical Trials /ID# 249946 | Lancaster | California | 93534 | — |
| Dermatology Research Associates /ID# 249829 | Los Angeles | California | 90045 | — |
| University of California Davis Health /ID# 250044 | Sacramento | California | 95817 | — |
| Clinical Trials Research Institute /ID# 250213 | Thousand Oaks | California | 91320-2130 | — |
| Western States Clinical Res /ID# 250274 | Wheat Ridge | Colorado | 80033-2896 | — |
| UConn Health /ID# 253807 | Farmington | Connecticut | 06030 | — |
| Yale Center for Clinical Investigation /ID# 254791 | New Haven | Connecticut | 06519 | — |
| Clearlyderm Dermatology /ID# 250457 | Boca Raton | Florida | 33428 | — |
| Skin Care Research Boca Raton /ID# 250458 | Boca Raton | Florida | 33486-2269 | — |
| Olympian Clinical Research /ID# 250453 | Clearwater | Florida | 33756 | — |
| Skin Care Research - Hollywood /ID# 250459 | Hollywood | Florida | 33021-6748 | — |
| Solutions Through Adv Rch /ID# 250455 | Jacksonville | Florida | 32256 | — |
| GSI Clinical Research, LLC /ID# 250768 | Margate | Florida | 33063 | — |
| D&H National Research Centers /ID# 250734 | Miami | Florida | 33155 | — |
| Florida International Rsrch cr /ID# 249667 | Miami | Florida | 33173 | — |
| Wellness Clinical Research - Miami Lakes /ID# 250236 | Miami Lakes | Florida | 33016 | — |
| Tory P Sullivan, MD PA /ID# 251136 | North Miami Beach | Florida | 33162-4708 | — |
| Precision Clinical Research /ID# 250990 | Sunrise | Florida | 33351-7311 | — |
| Advanced Clinical Research Institute /ID# 250460 | Tampa | Florida | 33607 | — |
| Metabolic Research Inst /ID# 250046 | West Palm Beach | Florida | 33401 | — |
| Treasure Valley Medical Research /ID# 250727 | Boise | Idaho | 83706 | — |
| Dawes Fretzin, LLC /ID# 250276 | Indianapolis | Indiana | 46256 | — |
| Randall Dermatology of West Lafayette /ID# 250234 | West Lafayette | Indiana | 47906-1569 | — |
| Beth Israel Deaconess Medical Center /ID# 251212 | Boston | Massachusetts | 02215-5400 | — |
| Beacon Clinical Research, LLC /ID# 251412 | Quincy | Massachusetts | 02169 | — |
| Clarkston Dermatology /ID# 250225 | Clarkston | Michigan | 48346 | — |
| Henry Ford Medical Center - New Center One /ID# 250228 | Detroit | Michigan | 48202-3046 | — |
| Cleaver Dermatology /ID# 250725 | Kirksville | Missouri | 63501-5362 | — |
| MediSearch Clinical Trials /ID# 250272 | Saint Joseph | Missouri | 64506 | — |
| Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616 | Lincoln | Nebraska | 68505-2343 | — |
| Physician Research Collaboration, LLC /ID# 251099 | Lincoln | Nebraska | 68516 | — |
| Montefiore Medical Center - Moses Campus /ID# 251214 | The Bronx | New York | 10467 | — |
| Derm of Greater Columbus /ID# 250049 | Bexley | Ohio | 43209-2422 | — |
| Univ Hosp Cleveland /ID# 250699 | Cleveland | Ohio | 44106 | — |
| Wright State Physicians - Fairborn /ID# 254167 | Fairborn | Ohio | 45324-2640 | — |
| Vital Prospects Clinical Research Institute, PC /ID# 249840 | Tulsa | Oklahoma | 74136-7049 | — |
| Oregon Dermatology and Research Center /ID# 250726 | Portland | Oregon | 97210 | — |
| Oregon Medical Research Center /ID# 249666 | Portland | Oregon | 97223 | — |
| Oregon Medical Research Center /ID# 250712 | Portland | Oregon | 97239 | — |
| University of Pittsburgh MC /ID# 251208 | Pittsburgh | Pennsylvania | 15260 | — |
| Duplicate_Medical University of South Carolina /ID# 251218 | Charleston | South Carolina | 29425-8903 | — |
| Health Concepts /ID# 250988 | Rapid City | South Dakota | 57702 | — |
| International Clinical Research - Tennessee LLC /ID# 250724 | Murfreesboro | Tennessee | 37130-2450 | — |
| Arlington Research Center, Inc /ID# 250468 | Arlington | Texas | 76011 | — |
| Orion Clinical Research /ID# 250473 | Austin | Texas | 78759-4100 | — |
| Bellaire Dermatology Associates /ID# 250739 | Bellaire | Texas | 77401 | — |
| Modern Research Associates, PLLC /ID# 250688 | Dallas | Texas | 75231 | — |
| Center for Clinical Studies - Houston - Northwest Freeway /ID# 250039 | Houston | Texas | 77065 | — |
| Texas Dermatology and Laser Specialists /ID# 250367 | San Antonio | Texas | 78218-3128 | — |
| University of Utah /ID# 250042 | Murray | Utah | 84107 | — |
| University of Virginia - Dermatology /ID# 254166 | Charlottesville | Virginia | 22903 | — |
| Virginia Clinical Research, Inc. /ID# 249908 | Norfolk | Virginia | 23502 | — |
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 199 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05601882, 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 Feb 14, 2025 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05601882 live on ClinicalTrials.gov.