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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002482-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab (Period 1) | Experimental | Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16. Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to < 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16. |
|
| Upadacitinib (Period 1) | Experimental | Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
|
| Dupilumab -> Upadacitinib (Period 2) | Experimental | At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with < EASI 75 or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Dupilumab is administered as a subcutaneous (SC) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists /ID# 250212 | Phoenix | Arizona | 85006 | United States | ||
| Alliance Dermatology and Mohs Center /ID# 249671 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41533220 | Derived | Bunick CG, Magnolo N, Moore A, Abe M, Gao X, Lynde C, Ibrahim N, Levy G, Calimlim BM, Wu X, Armendariz Y, Grada A, Eyerich K. Switching from Dupilumab to Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis After Inadequate Response to Dupilumab: Efficacy and Safety Results from Period 2 of Phase 3b/4 Study (LEVEL UP). Am J Clin Dermatol. 2026 Mar;27(2):391-399. doi: 10.1007/s40257-025-01003-0. Epub 2026 Jan 14. |
| Label | URL |
|---|---|
| Related info | View source |
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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, analyses plans, 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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Participants who met eligibility criteria were randomized in a 1:1 ratio to receive either upadacitinib 15 mg QD or dupilumab as per its label in Period 1. At Week 16, participants from both Period 1 arms with a < EASI 75 response entered Period 2; those from the dupilumab arm were offered the option to receive upadacitinib 15 mg QD while those from the upadacitinib arm either continued (if already receiving 30 mg) or escalated to upadacitinib 30 mg QD (if receiving 15 mg QD) until Week 32.
Participants were randomized at 214 sites located in 28 countries (Australia, Belgium, Bulgaria, Canada, China, Croatia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and the United States/Puerto Rico).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dupilumab (Period 1) | Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16. Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to < 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Baseline - Week 16) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2023 | Jan 24, 2025 |
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| Upadacitinib -> Upadacitinib 30 mg (Period 2) | Experimental | At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures. |
|
| Upadacitinib | Drug | Extended-release tablet |
|
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| Baseline and Week 16 |
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 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 using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Baseline and Week 16 |
| Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 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 using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Baseline and Week 16 |
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 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 using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Baseline and Week 4 |
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 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 using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Baseline and Week 2 |
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Baseline and Week 4 |
| Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Baseline and Week 2 |
| Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Baseline and Week 16 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Clinical Trials Institute - Northwest Arkansas /ID# 249838 | Fayetteville | Arkansas | 72703 | United States |
| Arkansas Research Trials /ID# 250722 | North Little Rock | Arkansas | 72217 | United States |
| Joseph Raoof Md,Inc /Id# 250211 | Encino | California | 91436 | United States |
| First OC Dermatology /ID# 250686 | Fountain Valley | California | 92708 | United States |
| Antelope Valley Clinical Trials /ID# 249946 | Lancaster | California | 93534 | United States |
| Dermatology Research Associates /ID# 249829 | Los Angeles | California | 90045 | United States |
| University of California Davis Health /ID# 250044 | Sacramento | California | 95817 | United States |
| Clinical Trials Research Institute /ID# 250213 | Thousand Oaks | California | 91320-2130 | United States |
| Western States Clinical Res /ID# 250274 | Wheat Ridge | Colorado | 80033-2896 | United States |
| UConn Health /ID# 253807 | Farmington | Connecticut | 06030 | United States |
| Yale Center for Clinical Investigation /ID# 254791 | New Haven | Connecticut | 06519 | United States |
| Clearlyderm Dermatology /ID# 250457 | Boca Raton | Florida | 33428 | United States |
| Skin Care Research Boca Raton /ID# 250458 | Boca Raton | Florida | 33486-2269 | United States |
| Olympian Clinical Research /ID# 250453 | Clearwater | Florida | 33756 | United States |
| Skin Care Research - Hollywood /ID# 250459 | Hollywood | Florida | 33021-6748 | United States |
| Solutions Through Adv Rch /ID# 250455 | Jacksonville | Florida | 32256 | United States |
| GSI Clinical Research, LLC /ID# 250768 | Margate | Florida | 33063 | United States |
| D&H National Research Centers /ID# 250734 | Miami | Florida | 33155 | United States |
| Florida International Rsrch cr /ID# 249667 | Miami | Florida | 33173 | United States |
| Wellness Clinical Research - Miami Lakes /ID# 250236 | Miami Lakes | Florida | 33016 | United States |
| Tory P Sullivan, MD PA /ID# 251136 | North Miami Beach | Florida | 33162-4708 | United States |
| Precision Clinical Research /ID# 250990 | Sunrise | Florida | 33351-7311 | United States |
| Advanced Clinical Research Institute /ID# 250460 | Tampa | Florida | 33607 | United States |
| Metabolic Research Inst /ID# 250046 | West Palm Beach | Florida | 33401 | United States |
| Treasure Valley Medical Research /ID# 250727 | Boise | Idaho | 83706 | United States |
| Dawes Fretzin, LLC /ID# 250276 | Indianapolis | Indiana | 46256 | United States |
| Randall Dermatology of West Lafayette /ID# 250234 | West Lafayette | Indiana | 47906-1569 | United States |
| Beth Israel Deaconess Medical Center /ID# 251212 | Boston | Massachusetts | 02215-5400 | United States |
| Beacon Clinical Research, LLC /ID# 251412 | Quincy | Massachusetts | 02169 | United States |
| Clarkston Dermatology /ID# 250225 | Clarkston | Michigan | 48346 | United States |
| Henry Ford Medical Center - New Center One /ID# 250228 | Detroit | Michigan | 48202-3046 | United States |
| Cleaver Dermatology /ID# 250725 | Kirksville | Missouri | 63501-5362 | United States |
| MediSearch Clinical Trials /ID# 250272 | Saint Joseph | Missouri | 64506 | United States |
| Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616 | Lincoln | Nebraska | 68505-2343 | United States |
| Physician Research Collaboration, LLC /ID# 251099 | Lincoln | Nebraska | 68516 | United States |
| Montefiore Medical Center - Moses Campus /ID# 251214 | The Bronx | New York | 10467 | United States |
| Derm of Greater Columbus /ID# 250049 | Bexley | Ohio | 43209-2422 | United States |
| Univ Hosp Cleveland /ID# 250699 | Cleveland | Ohio | 44106 | United States |
| Wright State Physicians - Fairborn /ID# 254167 | Fairborn | Ohio | 45324-2640 | United States |
| Vital Prospects Clinical Research Institute, PC /ID# 249840 | Tulsa | Oklahoma | 74136-7049 | United States |
| Oregon Dermatology and Research Center /ID# 250726 | Portland | Oregon | 97210 | United States |
| Oregon Medical Research Center /ID# 249666 | Portland | Oregon | 97223 | United States |
| Oregon Medical Research Center /ID# 250712 | Portland | Oregon | 97239 | United States |
| University of Pittsburgh MC /ID# 251208 | Pittsburgh | Pennsylvania | 15260 | United States |
| Duplicate_Medical University of South Carolina /ID# 251218 | Charleston | South Carolina | 29425-8903 | United States |
| Health Concepts /ID# 250988 | Rapid City | South Dakota | 57702 | United States |
| International Clinical Research - Tennessee LLC /ID# 250724 | Murfreesboro | Tennessee | 37130-2450 | United States |
| Arlington Research Center, Inc /ID# 250468 | Arlington | Texas | 76011 | United States |
| Orion Clinical Research /ID# 250473 | Austin | Texas | 78759-4100 | United States |
| Bellaire Dermatology Associates /ID# 250739 | Bellaire | Texas | 77401 | United States |
| Modern Research Associates, PLLC /ID# 250688 | Dallas | Texas | 75231 | United States |
| Center for Clinical Studies - Houston - Northwest Freeway /ID# 250039 | Houston | Texas | 77065 | United States |
| Texas Dermatology and Laser Specialists /ID# 250367 | San Antonio | Texas | 78218-3128 | United States |
| University of Utah /ID# 250042 | Murray | Utah | 84107 | United States |
| University of Virginia - Dermatology /ID# 254166 | Charlottesville | Virginia | 22903 | United States |
| Virginia Clinical Research, Inc. /ID# 249908 | Norfolk | Virginia | 23502 | United States |
| Premier Specialist /ID# 250572 | Kogarah | New South Wales | 2217 | Australia |
| Veracity Clinical Research /ID# 249943 | Woolloongabba | Queensland | 4102 | Australia |
| Skin Health Institute Inc /ID# 249938 | Carlton | Victoria | 3053 | Australia |
| Sinclair Dermatology - Melbourne /ID# 249937 | East Melbourne | Victoria | 3002 | Australia |
| Fremantle Dermatology /ID# 249941 | Fremantle | Western Australia | 6160 | Australia |
| Cliniques Universitaires UCL Saint-Luc /ID# 251403 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| Grand Hopital de Charleroi /ID# 251401 | Charleroi | Hainaut | 6000 | Belgium |
| Universitair Ziekenhuis Leuven /ID# 251399 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| CHU de Liege /ID# 251400 | Liège | 4000 | Belgium |
| UMHAT Dr Georgi Stranski EAD /ID# 251268 | Pleven | Smolyan | 5800 | Bulgaria |
| Diagnostic Consultative Center Aleksandrovska /ID# 251137 | Sofiya | Sofia | 1431 | Bulgaria |
| DCC Pulmed AD /ID# 251271 | Plovdiv | 4001 | Bulgaria |
| Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 251272 | Sofia | 1407 | Bulgaria |
| Diagnostic consultative center Focus-5 /ID# 251269 | Sofia | 1463 | Bulgaria |
| Medical Center Euroderma /ID# 251267 | Sofia | 1606 | Bulgaria |
| Medical center EuroHealth /ID# 251270 | Sofia | 1606 | Bulgaria |
| Military Medical Academy Multiprofile Hospital /ID# 251187 | Sofia | 1606 | Bulgaria |
| MC Zara-Med EOOD /ID# 251135 | Stara Zagora | 6000 | Bulgaria |
| Dermatology Research Institute - Blackfoot Trail /ID# 251642 | Calgary | Alberta | T2J 7E1 | Canada |
| Beacon Dermatology Inc /ID# 250336 | Calgary | Alberta | T3A 2N1 | Canada |
| Alberta DermaSurgery Centre /ID# 250217 | Edmonton | Alberta | T6G 1C3 | Canada |
| Dr. Chih-ho Hong Medical Inc. /ID# 251643 | Surrey | British Columbia | V3R 6A7 | Canada |
| Enverus Medical Research /ID# 251645 | Surrey | British Columbia | V3V 0C6 | Canada |
| Wiseman Dermatology Research /ID# 250219 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Brunswick Dermatology Center /ID# 250220 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| LEADER Research /ID# 251647 | Hamilton | Ontario | L8L 3C3 | Canada |
| DermEffects /ID# 250223 | London | Ontario | N6H 5L5 | Canada |
| Lynde Institute for Dermatology /ID# 251854 | Markham | Ontario | L3P 1X2 | Canada |
| DermEdge Research Inc. /ID# 250216 | Mississauga | Ontario | L4Y 4C5 | Canada |
| SKiN Centre for Dermatology /ID# 251853 | Peterborough | Ontario | K9J 5K2 | Canada |
| Toronto Dermatology Centre /ID# 252098 | Toronto | Ontario | M3H 5Y8 | Canada |
| Research Toronto /ID# 250222 | Toronto | Ontario | M4W 2N4 | Canada |
| Private Practice - Dr. Kim Papp Clinical Research /ID# 251644 | Waterloo | Ontario | N2J 1C4 | Canada |
| Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427 | Québec | Quebec | G1V 4X7 | Canada |
| The First Affiliated Hospital Of Fujian Medical University /ID# 249674 | Fuzhou | Fujian | 350005 | China |
| Dermatology Hospital of Southern Medical University /ID# 250121 | Guangzhou | Guangdong | 510091 | China |
| Guangzhou First People's Hospital /ID# 249695 | Guangzhou | Guangdong | 510180 | China |
| The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694 | Guangzhou | Guangdong | 510260 | China |
| The University of Hong Kong- Shenzhen Hospital /ID# 249436 | Shenzhen | Guangdong | 518048 | China |
| The Second Xiangya Hospital of Central South University /ID# 249657 | Changsha | Guizhou | 410011 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485 | Wuhan | Hubei | 430022 | China |
| The First Hospital of China Medical University /ID# 249638 | Shenyang | Liaoning | 110001 | China |
| Huashan Hospital, Fudan University /ID# 250025 | Shanghai | Shanghai Municipality | 200040 | China |
| Shanghai Skin Disease Hospital /ID# 249392 | Shanghai | Shanghai Municipality | 200443 | China |
| Tianjin Medical University General Hospital /ID# 250246 | Tianjin | Tianjin Municipality | 300052 | China |
| Hangzhou First People's Hospital /ID# 249437 | Hangzhou | Zhejiang | 310003 | China |
| The second affiliated hospital of Zhejiang University school of medicine /ID# 249655 | Hangzhou | Zhejiang | 310009 | China |
| Zhejiang Provincial People's Hospital /ID# 249653 | Hangzhou | Zhejiang | 310014 | China |
| Poliklinika Solmed /ID# 252138 | Grad Zagreb | City of Zagreb | 10000 | Croatia |
| DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591 | Zagreb | City of Zagreb | 10000 | Croatia |
| Djecja bolnica Srebrnjak /ID# 249594 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinicki bolnicki centar Zagreb /ID# 249596 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinika za dječje bolesti Zagreb /ID# 249590 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinicki bolnicki centar Rijeka /ID# 249593 | Rijeka | Primorje-Gorski Kotar County | 51000 | Croatia |
| Klinicki Bolnicki Centar (KBC) Split /ID# 249879 | Split | Split-Dalmatia County | 21000 | Croatia |
| Bispebjerg and Frederiksberg Hospital /ID# 248902 | Copenhagen NV | Capital Region | 2400 | Denmark |
| Herlev and Gentofte Hospital /ID# 248900 | Hellerup | Capital Region | 2900 | Denmark |
| Aarhus Universitetshospital - Skejby /ID# 248899 | Aarhus | Central Jutland | 8200 | Denmark |
| Roskilde Sygehus /ID# 248901 | Roskilde | Region Sjælland | 4000 | Denmark |
| Hopital Saint Joseph /ID# 251053 | Marseille | Bouches-du-Rhone | 13008 | France |
| CHU de Nantes, Hotel Dieu -HME /ID# 251347 | Nantes | Pays de la Loire Region | 44000 | France |
| HCL - Hopital Lyon Sud /ID# 251343 | Pierre-Bénite | Rhone | 69495 | France |
| Hôpital Saint-Louis /ID# 251052 | Paris | 75010 | France |
| Hôpital Charles-Nicolle /ID# 251055 | Rouen | 76000 | France |
| CHU Toulouse - Hopital Larrey /ID# 251344 | Toulouse | 31400 | France |
| Universitaetsklinikum Freiburg /ID# 249555 | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitaetsklinik Heidelberg /ID# 251458 | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Universitaetsklinikum Tuebingen /ID# 249552 | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306 | Blankenfelde-Mahlow | Brandenburg | 15831 | Germany |
| Klinikum Darmstadt /ID# 251391 | Darmstadt | Hesse | 64283 | Germany |
| Universitaetsklinikum Frankfurt /ID# 249544 | Frankfurt am Main | Hesse | 60590 | Germany |
| Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 251392 | Bramsche | Lower Saxony | 49565 | Germany |
| Universitaetsklinikum Bonn /ID# 250307 | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Universitaetsklinikum Muenster /ID# 249404 | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitaetsmedizin Mainz /ID# 249549 | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Fachklinik Bad Bentheim /ID# 249545 | Bad Bentheim | Saarland | 48455 | Germany |
| Universitaetsklinikum Leipzig /ID# 249562 | Leipzig | Saxony | 04103 | Germany |
| Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560 | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566 | Bochum | 44793 | Germany |
| Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 251844 | Dresden | 01307 | Germany |
| Derma Study Center Friedrichshafen GmbH /ID# 251460 | Friedrichshafen | 88045 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf /ID# 249547 | Hamburg | 20246 | Germany |
| Dermatologikum Hamburg /ID# 251390 | Hamburg | 20354 | Germany |
| Klinikum rechts der Isar /ID# 249548 | Munich | 81675 | Germany |
| 401 GSNA - 401 Army General Hospital /ID# 251843 | Athens | Attica | 11527 | Greece |
| General Hospital Andreas Syggros /ID# 251842 | Athens | Attica | 16121 | Greece |
| Papageorgiou General Hospital /ID# 251840 | Thessaloniki | Evrytania | 56429 | Greece |
| Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 249850 | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
| Debreceni Egyetem-Klinikai Kozpont /ID# 249849 | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Gyongyosi Bugat Pal Korhaz /ID# 251367 | Gyöngyös | Heves County | 3200 | Hungary |
| Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419 | Pecs | Nógrád megye | 7624 | Hungary |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 249848 | Kaposvár | Somogy County | 7400 | Hungary |
| Clinexpert Kft /ID# 249822 | Budapest | 1033 | Hungary |
| Semmelweis Egyetem /ID# 251368 | Budapest | 1085 | Hungary |
| UNO Medical Trials /ID# 249820 | Budapest | 1135 | Hungary |
| DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 249819 | Debrecen | 4031 | Hungary |
| Szegedi Tudományegyetem /ID# 249818 | Szeged | 6720 | Hungary |
| Allergo-Derm Bakos Kft. /ID# 249821 | Szolnok | 5000 | Hungary |
| Hadassah Medical Center-Hebrew University /ID# 251576 | Jerusalem | Jerusalem | 91120 | Israel |
| Rabin Medical Center /ID# 251578 | Haifa | 4941492 | Israel |
| CAST - Center for Advanced Studies and Technology /ID# 251495 | Chieti | L Aquila | 66100 | Italy |
| Presidio Ospedaliero San Salvatore /ID# 250127 | L’Aquila | L Aquila | 67100 | Italy |
| IRCCS Istituto Clinico Humanitas /ID# 251493 | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250125 | Rome | Roma | 00133 | Italy |
| IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558 | Rome | Roma | 00144 | Italy |
| Policlinico Agostino Gemelli /ID# 251494 | Rome | Roma | 00168 | Italy |
| ASST degli Spedali Civili di Brescia /ID# 250129 | Brescia | 25123 | Italy |
| Ospedale Piero Palagi /ID# 250206 | Florence | 50122 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 250123 | Milan | 20122 | Italy |
| Azienda Ospedaliero-Universitaria di Modena /ID# 250128 | Modena | 41124 | Italy |
| Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 251572 | Perugia | 06156 | Italy |
| Azienda Ospedaliero Universitaria Pisana /ID# 250124 | Pisa | 56126 | Italy |
| Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 252549 | Sapporo | Hokkaido | 060-0063 | Japan |
| Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 252554 | Kawasaki-shi | Kanagawa | 211-0063 | Japan |
| National Hospital Organization Sagamihara National Hospital /ID# 254518 | Sagamihara-shi | Kanagawa | 252-0392 | Japan |
| Queen's Square Medical Center, Dermatology and Allergology /ID# 252551 | Yokohama | Kanagawa | 220-6208 | Japan |
| Osaka Habikino Medical Center /ID# 252550 | Habikino-shi | Osaka | 583-8588 | Japan |
| Dermatology and Ophthalmology Kume Clinic /ID# 254570 | Sakai-shi | Osaka | 5938324 | Japan |
| Naoko Dermatology Clinic /ID# 254571 | Setagaya-ku | Tokyo | 158-0097 | Japan |
| Centro de Dermatologia de Monterrey /ID# 249126 | Monterrey | Estado de Baja California | 64640 | Mexico |
| Eukarya PharmaSite, SC /ID# 249702 | Monterrey | Nuevo León | 64718 | Mexico |
| Cryptex Investigacion Clinica S.A de C.V /ID# 249994 | Mexico City | 06100 | Mexico |
| Clinical Research Institute SC /ID# 249647 | Tlalnepantla | 54055 | Mexico |
| Arké Estudios Clinicos Veracruz /ID# 250147 | Veracruz | 91910 | Mexico |
| Bravis Ziekenhuis /ID# 251395 | Bergen op Zoom | North Brabant | 4624 VT | Netherlands |
| Amsterdam UMC, locatie AMC /ID# 251397 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Solumed Centrum Medyczne /ID# 249641 | Poznan | Greater Poland Voivodeship | 60-529 | Poland |
| MICS Centrum Medyczne Torun /ID# 251433 | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny /ID# 252082 | Cracow | Lesser Poland Voivodeship | 30-438 | Poland |
| Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 251437 | Krakow | Lesser Poland Voivodeship | 31-011 | Poland |
| Klinika Ambroziak Sp. z o.o. /ID# 249406 | Warsaw | Masovian Voivodeship | 02-953 | Poland |
| Royalderm Agnieszka Nawrocka /ID# 251432 | Warsaw | Masovian Voivodeship | 02-962 | Poland |
| Bodyclinic Sp. z o.o. sp.k. /ID# 249599 | Warsaw | Masovian Voivodeship | 03-712 | Poland |
| Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o /ID# 249598 | Iwonicz-Zdrój | Podkarpackie Voivodeship | 38-440 | Poland |
| INTER CLINIC Piotr Adrian Klimiuk /ID# 251430 | Bialystok | Podlaskie Voivodeship | 15-077 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431 | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 251438 | Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630 | Cracow | 30-033 | Poland |
| Dermed Centrum Medyczne Sp. z o.o /ID# 251429 | Lodz | Łódź Voivodeship | 90-265 | Poland |
| Centro Hospitalar Do Alto Ave - Hospital Senhora Da Oliveira /ID# 249196 | Guimarães | Braga District | 4839-008 | Portugal |
| Hospital CUF Descobertas /ID# 249193 | Lisboa | Madeira | 1998-018 | Portugal |
| Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191 | Porto | Madeira | 4099-001 | Portugal |
| Hospital Garcia de Orta /ID# 251455 | Almada | Setúbal District | 2805-267 | Portugal |
| 2CA-Braga, Hospital de Braga /ID# 250480 | Braga | 4710-243 | Portugal |
| Unidade Local de Saude da Regiao de Leiria, EPE /ID# 249194 | Leiria | 2410-197 | Portugal |
| Centro Hospitalar de Lisboa Central /ID# 249195 | Lisbon | 1169-050 | Portugal |
| Unidade Local de Saúde de Matosinhos, EPE /ID# 249197 | Matosinhos Municipality | 4464-513 | Portugal |
| Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192 | Porto | 4200-319 | Portugal |
| Dr. Samuel Sanchez PSC /ID# 250389 | Caguas | 00727 | Puerto Rico |
| Alma M. Cruz Santana, MD-Private practice /ID# 250393 | Carolina | 00985 | Puerto Rico |
| Clinical Research Puerto Rico /ID# 250394 | San Juan | 00909-1711 | Puerto Rico |
| GCM Medical Group PSC /ID# 250391 | San Juan | 00917-3104 | Puerto Rico |
| Bio Terra Med SRL /ID# 249624 | Bucharest | Bucharest | 010701 | Romania |
| Private Practice - Dr. Orasan Remus /ID# 249625 | Cluj-Napoca | Cluj | 400006 | Romania |
| Derma therapy spol /ID# 249783 | Bratislava | Bratislava Region | 851 01 | Slovakia |
| Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746 | Bratislava | 811 09 | Slovakia |
| BeneDerma s.r.o. /ID# 251791 | Bratislava | 841 04 | Slovakia |
| University of Pretoria /ID# 250208 | Pretoria | Gauteng | 0001 | South Africa |
| About Allergy /ID# 249697 | Pretoria | Gauteng | 0181 | South Africa |
| Highway Medical Centre /ID# 250103 | Durban | KwaZulu-Natal | 3630 | South Africa |
| Allergy & Immunology (AIU) /ID# 249619 | Cape Town | Western Cape | 7700 | South Africa |
| Spoke Research Inc /ID# 250091 | CAPE TOWN Milnerton | Western Cape | 7441 | South Africa |
| Pusan National University Hospital /ID# 249852 | Busan | Busan Gwang Yeogsi | 49241 | South Korea |
| Kyungpook National University Hospital /ID# 249855 | Junggu | Daegu Gwang Yeogsi | 41944 | South Korea |
| Korea University Ansan Hospital /ID# 249814 | Ansan-si | Gyeonggido | 15355 | South Korea |
| Soon Chun Hyang University Hospital Bucheon /ID# 249812 | Bucheon-si | Gyeonggido | 14584 | South Korea |
| Chungang University Hospital /ID# 251490 | Dongjak-gu | Gyeonggido | 06973 | South Korea |
| Ajou University Hospital /ID# 251491 | Suwon | Gyeonggido | 16499 | South Korea |
| Seoul National University Hospital /ID# 251492 | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Konkuk University Medical Center /ID# 249811 | Seoul | Seoul Teugbyeolsi | 05030 | South Korea |
| Hospital Universitario Germans Trias i Pujol /ID# 251523 | Badalona | Barcelona | 08916 | Spain |
| Hospital Sant Joan de Deu /ID# 249602 | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Universitario Basurto /ID# 249784 | Bilbao | Vizcaya | 48013 | Spain |
| Hospital General Universitario de Alicante Doctor Balmis /ID# 251517 | Alicante | 03010 | Spain |
| Hospital Universitario Virgen de las Nieves /ID# 249785 | Granada | 18014 | Spain |
| Hospital Universitario La Paz /ID# 251518 | Madrid | 28046 | Spain |
| Hospital Universitario Virgen Macarena /ID# 249603 | Seville | 41009 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 251524 | Valencia | 46026 | Spain |
| Skane University hospital /ID# 250332 | Malmö | Skåne County | 214 28 | Sweden |
| Karolinska University Hospital Solna /ID# 250328 | Solna | Stockholm County | 171 64 | Sweden |
| Norrlands University hospital /ID# 250329 | Umeå | Västerbotten County | 581 85 | Sweden |
| Malarsjukhuset /ID# 251908 | Eskilstuna | 633 49 | Sweden |
| Kantonsspital St. Gallen /ID# 250606 | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Inselspital, Universitaetsspital Bern /ID# 250577 | Bern | 3010 | Switzerland |
| Kaohsiung Chang Gung Memorial Hospital /ID# 249260 | Kaohsiung City | Kaohsiung | 833 | Taiwan |
| Taichung Veterans General Hospital /ID# 249261 | Taichung | Keelung | 40705 | Taiwan |
| National Taiwan University Hospital /ID# 249258 | Taipei City | Taipei | 100 | Taiwan |
| National Taiwan University Hospital - Hsinchu branch /ID# 249265 | Hsinchu | 30059 | Taiwan |
| Taipei Medical University Shuang Ho Hospital /ID# 249256 | New Taipei City | 23561 | Taiwan |
| Mackay Memorial Hospital /ID# 249259 | Taipei | 104 | Taiwan |
| Taipei Veterans General Hosp /ID# 249263 | Taipei | 11217 | Taiwan |
| Taipei Municipal Wan Fang Hospital /ID# 251500 | Taipei | 116 | Taiwan |
| Linkou Chang Gung Memorial Hospital /ID# 249257 | Taoyuan City | 333 | Taiwan |
| Gaziantep Universitesi /ID# 249868 | Gaziantep | Adana | 27310 | Turkey (Türkiye) |
| Ankara City Hospital /ID# 249870 | Ankara | 06800 | Turkey (Türkiye) |
| Akdeniz Universitesi Tip Fakul /ID# 249866 | Antalya | 07059 | Turkey (Türkiye) |
| Uludag University Medical Faculty /ID# 249864 | Bursa | 16059 | Turkey (Türkiye) |
| Erciyes University Medical Faculty /ID# 249863 | Kayseri | 38039 | Turkey (Türkiye) |
| Ondokuz Mayis Universitesi /ID# 249865 | Samsun | 55139 | Turkey (Türkiye) |
| FG001 | Upadacitinib (Period 1) | Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
| FG002 | Dupilumab -> Upadacitinib (Period 2) | At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with < EASI 75 or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32. |
| FG003 | Upadacitinib -> Upadacitinib 30 mg (Period 2) | At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Period 2 (Week 16 - Week 32) |
|
|
Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline, analyzed per the treatment group to which they were randomized
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dupilumab (Period 1) | Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16. Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to < 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16. |
| BG001 | Upadacitinib (Period 1) | Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 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 using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 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 using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 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 using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 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 using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
|
All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dupilumab (Period 1) | Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16. Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to < 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16. | 0 | 462 | 5 | 462 | 87 | 462 |
| EG001 | Upadacitinib (Period 1) | Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. | 0 | 458 | 4 | 458 | 156 | 458 |
| EG002 | Dupilumab -> Upadacitinib (Period 2) | At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with < EASI 75 or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32. | 0 | 208 | 0 | 208 | 57 | 208 |
| EG003 | Upadacitinib -> Upadacitinib 30 mg (Period 2) | At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures. | 0 | 147 | 4 | 147 | 30 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| JUVENILE IDIOPATHIC ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| MIGRAINE WITHOUT AURA | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERY OCCLUSION | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2024 | Jan 24, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
| C000613732 | upadacitinib |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Other, not specified |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Upadacitinib (Period 1) | Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
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Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
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Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
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Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
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Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
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| OG001 | Upadacitinib (Period 1) | Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
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| OG001 | Upadacitinib (Period 1) | Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
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| OG001 | Upadacitinib (Period 1) | Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response. |
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