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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002264-57 | EudraCT Number |
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This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
The study is comprised of a 35-day screening period, a 24-week double-blinded treatment period, and a follow-up visit 12 weeks after the last dose. Participants who complete Week 24 have the option to enroll into an open-label study (Study M19-850; NCT04195698) of upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52 weeks.
Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either upadacitinib or dupilumab. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and age (<40, ≥ 40 to < 65, ≥ 65 years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib 30 mg QD | Experimental | Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22. |
|
| Dupilumab 300 mg EOW | Experimental | Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Biological | Extended release tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at 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 using an electronic hand-held device. Participants were asked to rate 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). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement. |
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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 |
|---|---|---|---|---|---|---|
| Clinical Research Center AL /ID# 210277 | Birmingham | Alabama | 35209-6802 | United States | ||
| University of Arkansas for Medical Sciences /ID# 211688 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34347860 | Result | Blauvelt A, Teixeira HD, Simpson EL, Costanzo A, De Bruin-Weller M, Barbarot S, Prajapati VH, Lio P, Hu X, Wu T, Liu J, Ladizinski B, Chu AD, Eyerich K. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2021 Sep 1;157(9):1047-1055. doi: 10.1001/jamadermatol.2021.3023. | |
| 42223292 |
| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | 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 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.
For details on when studies are available for sharing, please refer to the link below.
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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Participants were randomly assigned in a 1:1 ratio to receive upadacitinib or dupilumab. Randomization was stratified by disease severity (Validated Investigator Global Assessment Scale for Atopic Dermatitis [vIGA-AD] moderate [3] vs severe [4]) and age (<40, ≥ 40 to < 65, ≥ 65 years).
Participants were randomized at 128 sites located in 22 countries (Australia, Canada, Croatia, Czechia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Taiwan, Ukraine, United Kingdom, and the United States).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dupilumab 300 mg EOW | Participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally once a day (QD) up to Week 24. |
| FG001 | Upadacitinib 30 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Nov 10, 2020 | Jan 10, 2022 |
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| Dupilumab | Biological | Dupilumab is administered as a subcutaneous (SC) injection |
|
|
| Placebo to dupilumab | Drug | Placebo administered as a subcutaneous injection |
|
| Placebo to upadacitinib | Drug | Tablet |
|
| Baseline (Week 0) to Week 16 |
| Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Baseline and Week 16 |
| Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Baseline and Week 16 |
| Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at 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 using an electronic hand-held device. Participants were asked to rate 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). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement. | Baseline (Week 0) to Week 4 |
| Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Baseline and Week 2 |
| Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at 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 using an electronic hand-held device. Participants were asked to rate 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). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement. | Baseline (Week 0) to Week 1 |
| Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at 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 using an electronic hand-held device. Participants were asked to rate 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 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Tien Q Nguyen MD, Inc /ID# 208934 | Fountain Valley | California | 92708-3701 | United States |
| UCSF Fresno /ID# 213253 | Fresno | California | 93701-2302 | United States |
| Jonathan Corren, MD. INC /ID# 208987 | Los Angeles | California | 90025-4749 | United States |
| California Allergy and Asthma Medical Group /ID# 213680 | Los Angeles | California | 90025-7014 | United States |
| Dermatology Research Associates /ID# 209097 | Los Angeles | California | 90045 | United States |
| Los Angelos Cataract Center /ID# 208524 | Los Angeles | California | 90056 | United States |
| Dermatology Clinical Trials /ID# 214622 | Newport Beach | California | 92660-7853 | United States |
| UC Davis Health /ID# 209285 | Sacramento | California | 95816 | United States |
| Ucsd /Id# 208990 | San Diego | California | 92103 | United States |
| Clinical Science Institute /ID# 211022 | Santa Monica | California | 90404-2102 | United States |
| The Community Research of South Florida /ID# 211145 | Hialeah | Florida | 33016-1897 | United States |
| Miami Dermatology and Laser Institute /ID# 212938 | Miami | Florida | 33173-3570 | United States |
| Florida International Rsrch cr /ID# 211562 | Miami | Florida | 33173 | United States |
| Progressive Medical Research /ID# 211994 | Port Orange | Florida | 32127 | United States |
| GCP Research /ID# 216020 | St. Petersburg | Florida | 33705 | United States |
| Clinical Research Trials of Florida, Inc. /ID# 210751 | Tampa | Florida | 33607 | United States |
| Integrated Clinical Research LLC /ID# 208831 | West Palm Beach | Florida | 33406-6063 | United States |
| Georgia Pollens Clinical Research Centers, Inc /ID# 211092 | Albany | Georgia | 31707-1282 | United States |
| Meridian Clinical Research Dermatology /ID# 213251 | Savannah | Georgia | 31406-2632 | United States |
| Northwestern University Feinberg School of Medicine /ID# 208680 | Chicago | Illinois | 60611-2927 | United States |
| Medical Dermatology Associates of Chicago /ID# 210265 | Chicago | Illinois | 60654-6903 | United States |
| Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058 | Normal | Illinois | 61761 | United States |
| Dawes Fretzin, LLC /ID# 209187 | Indianapolis | Indiana | 46256 | United States |
| Beacon Clinical Research, LLC /ID# 209280 | Quincy | Massachusetts | 02169 | United States |
| Clarkston Skin Research /ID# 208739 | Clarkston | Michigan | 48346 | United States |
| Henry Ford Health System /ID# 208741 | Detroit | Michigan | 48202 | United States |
| Clinical Research Institute, Inc /ID# 210852 | Minneapolis | Minnesota | 55402-2606 | United States |
| Allergy, Asthma & Immunology Associates, PC /ID# 213481 | Lincoln | Nebraska | 68505-2343 | United States |
| Skin Specialists, PC /ID# 208843 | Omaha | Nebraska | 68144 | United States |
| Dartmouth-Hitchcock Medical Center /ID# 213727 | Lebanon | New Hampshire | 03756 | United States |
| Forest Hills Dermatology Group /ID# 209249 | Kew Gardens | New York | 11415 | United States |
| Montefiore Medical Center /ID# 209647 | The Bronx | New York | 10467 | United States |
| Wake Forest Univ HS /ID# 208892 | Winston-Salem | North Carolina | 27157 | United States |
| Univ Hosp Cleveland /ID# 208852 | Cleveland | Ohio | 44106 | United States |
| The Ohio State University /ID# 209254 | Columbus | Ohio | 43210-1257 | United States |
| Southside Dermatology /ID# 212004 | Tulsa | Oklahoma | 74132 | United States |
| Oregon Medical Res Center PC /ID# 208807 | Portland | Oregon | 97223 | United States |
| Oregon Health and Science University /ID# 208809 | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina /ID# 211054 | Charleston | South Carolina | 29425 | United States |
| Clinical Research Solutions, LLC /ID# 212542 | Jackson | Tennessee | 38305-2163 | United States |
| Orion Clinical Research /ID# 208765 | Austin | Texas | 78759-4100 | United States |
| DiscoveResearch, Inc. /ID# 213171 | Bryan | Texas | 77802 | United States |
| Epiphany Dermatology - Fort Worth /ID# 211187 | Fort Worth | Texas | 76244-6548 | United States |
| Sante Clinical Research /ID# 212970 | Kerrville | Texas | 78028-9640 | United States |
| Stephen Miller, MD PA /ID# 210071 | San Antonio | Texas | 78249 | United States |
| Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153 | Sugar Land | Texas | 77479-3153 | United States |
| University of Utah /ID# 209001 | Salt Lake City | Utah | 84112-5500 | United States |
| Clinical Research Partners, LLC /ID# 212262 | Richmond | Virginia | 23220-4459 | United States |
| Premier Clinical Research /ID# 212142 | Spokane | Washington | 99202 | United States |
| West Virginia Research Inst /ID# 212730 | South Charleston | West Virginia | 25309 | United States |
| Holdsworth House Medical Practice /ID# 214565 | Darlinghurst | New South Wales | 2010 | Australia |
| The Skin Hospital /ID# 214401 | Darlinghurst | New South Wales | 2010 | Australia |
| Veracity Clinical Research /ID# 211134 | Woolloongabba | Queensland | 4102 | Australia |
| Sinclair Dermatology /ID# 209395 | East Melbourne | Victoria | 3002 | Australia |
| Burswood Dermatology /ID# 214875 | Victoria Park | Western Australia | 6100 | Australia |
| Kirk Barber Research, CA /ID# 209504 | Calgary | Alberta | T2G 1B1 | Canada |
| Dermatology Research Institute Inc. /ID# 210942 | Calgary | Alberta | T2J 7E1 | Canada |
| Dr. Chih-ho Hong Medical Inc. /ID# 211032 | Surrey | British Columbia | V3R 6A7 | Canada |
| Enverus Medical Research /ID# 209503 | Surrey | British Columbia | V3V 0C6 | Canada |
| Dr. Wei Jing Loo Medicine Prof /ID# 211400 | London | Ontario | N6H 5L5 | Canada |
| Lynderm Research Inc. /ID# 209505 | Markham | Ontario | L3P 1X2 | Canada |
| DermEdge Research Inc. /ID# 211122 | Mississauga | Ontario | L5H 1G9 | Canada |
| Niakosari Medicine Professional Corporation /ID# 211401 | Toronto | Ontario | M2M 4J5 | Canada |
| K. Papp Clinical Research /ID# 209509 | Waterloo | Ontario | N2J 1C4 | Canada |
| Dre Angelique Gagne-Henley M.D. inc. /ID# 209498 | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 209935 | Zagreb | City of Zagreb | 10000 | Croatia |
| Djecja bolnica Srebrnjak /ID# 209939 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinicki bolnicki centar Zagreb /ID# 209976 | Zagreb | City of Zagreb | 10000 | Croatia |
| Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 209937 | Ivanić-Grad | Zagreb County | 10310 | Croatia |
| Fakultni Nemocnice Brno /ID# 212968 | Brno | 625 00 | Czechia |
| FN Hradec Kralove /ID# 209116 | Hradec Králové | 500 05 | Czechia |
| Nemocnice Jihlava, prispevkova organizace /ID# 209131 | Jihlava | 586 01 | Czechia |
| Fakultni nemocnice Ostrava /ID# 209117 | Ostrava | 708 52 | Czechia |
| Fakultni Nemocnice v Motole /ID# 209209 | Prague | 150 06 | Czechia |
| Keski-pohjanmaa Central Hospital /ID# 209534 | Kokkola | Keski-Pohjanmaa | 67200 | Finland |
| Oulu University Hospital /ID# 208961 | Oulu | North Ostrobothnia | 90220 | Finland |
| Mikkeli Central Hospital /ID# 210125 | Mikkeli | 50100 | Finland |
| Pihlajalinna Turku /ID# 209599 | Turku | 20100 | Finland |
| CHRU Lille - Hopital Claude Huriez /ID# 209317 | Lille | Hauts-de-France | 59045 | France |
| CHU de Nantes - Hotel Dieu /ID# 208974 | Nantes | Pays de la Loire Region | 44093 | France |
| Charles Nicolle CHU Rouen /ID# 208973 | Rouen | Seine-Maritime | 76031 | France |
| Hopital de la Timone /ID# 211245 | Marseille | 13385 | France |
| Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 213374 | Nice | 06202 | France |
| Polyclinique Courlancy /ID# 208975 | Reims | 51100 | France |
| Hopital Larrey - CHU de Toulouse /ID# 208976 | Toulouse | 31059 | France |
| Universitatsklinikum Munster /ID# 210935 | Munster | Lower Saxony | 48149 | Germany |
| Gemeinschaftspraxis /ID# 211174 | Blankenfeld-mahlow | 15831 | Germany |
| Hautklinik Klinikum Darmstadt /ID# 210938 | Darmstadt | 64283 | Germany |
| Universitaetsklinikum Frankfurt /ID# 210934 | Frankfurt | 60590 | Germany |
| Medizinische Hochschule Hannover /ID# 210939 | Hanover | 30625 | Germany |
| TU Uniklinik Munchen /ID# 210937 | Munich | 80802 | Germany |
| Oroshazi Korhaz /ID# 210150 | Orosháza | Bekes County | 5900 | Hungary |
| Uno Medical Trials Kft /ID# 211177 | Budapest XIII | 1135 | Hungary |
| Debreceni Egyetem Klinikai Kozpont /ID# 210893 | Debrecen | 4032 | Hungary |
| Somogy Megyei Kaposi Mor Oktat /ID# 210149 | Kaposvár | 7400 | Hungary |
| Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 210892 | Pécs | 7624 | Hungary |
| St Vincent's University Hosp /ID# 208441 | Dublin | D04 T6F4 | Ireland |
| University Hospital Waterford /ID# 208442 | Waterford | X91 ER8E | Ireland |
| HaEmek Medical Center /ID# 210153 | Afula | 1834111 | Israel |
| Rabin Medical Center /ID# 210012 | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center /ID# 210013 | Ramat Gan | 5239424 | Israel |
| Ichilov Medical Center /ID# 210014 | Tel Aviv | 64239 | Israel |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 210632 | Milan | Lombardy | 20122 | Italy |
| IBD Center - IRCCS Istituto Clinico Humanitas /ID# 215726 | Rozzano | Milano | 20089 | Italy |
| A.O. Policlinico Sant'Orsola Malpighi /ID# 209111 | Bologna | 40138 | Italy |
| A.O.U. di Brescia /ID# 209115 | Brescia | 25123 | Italy |
| Ospedale San Giovanni di Dio /ID# 209109 | Cagliari | 9124 | Italy |
| AO Univ di Modena /ID# 209110 | Modena | 41100 | Italy |
| Policlinico Univ Tor Vergata /ID# 209112 | Rome | 00133 | Italy |
| Hospital Sultan Ismail /ID# 211037 | Johor Bahru | Johor | 81100 | Malaysia |
| Hospital Pakar Sultanah Fatimah /ID# 210185 | Muar town | Johor | 84000 | Malaysia |
| UKM Medical Centre /ID# 209178 | Kuala Lumpur | Selangor | 56000 | Malaysia |
| Hospital Pulau Pinang /ID# 210212 | George Town | 10450 | Malaysia |
| University Malaya Med Ctr /ID# 208861 | Kuala Lumpur | 59100 | Malaysia |
| Hospital Putrajaya /ID# 209177 | Putrajaya | 62250 | Malaysia |
| Bravis Ziekenhuis /ID# 208584 | Bergen op Zoom | North Brabant | 4624 VT | Netherlands |
| Academisch Medisch Centrum /ID# 208578 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Centrum Oosterwal /ID# 209641 | Alkmaar | 1817 MS | Netherlands |
| Universitair Medisch Centrum Groningen /ID# 208583 | Groningen | 9713 GZ | Netherlands |
| Erasmus Medisch Centrum /ID# 208582 | Rotterdam | 3015 GD | Netherlands |
| Universitair Medisch Centrum Utrecht /ID# 208579 | Utrecht | 3584 CX | Netherlands |
| Optimal Clinical Trials Ltd /ID# 209475 | Auckland | 1010 | New Zealand |
| Clinical Trials NZ /ID# 215590 | Hamilton | 3206 | New Zealand |
| Wellington Hospital (Capital and Coast District Health Board) /ID# 215001 | Wellington | 6021 | New Zealand |
| St. Olavs Hospital HF /ID# 209137 | Trondheim | Sor-Trondelag | 7006 | Norway |
| Universitetssykehuset N-Norge, Harstad /ID# 209105 | Harstad | Troms | 9406 | Norway |
| Universitetssykehuset N-Norge, Tromso /ID# 209103 | Tromsø | Troms | 9019 | Norway |
| Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy /ID# 211103 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-094 | Poland |
| Pratia MCM Krakow /ID# 207444 | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Klinika Ambroziak Sp. z o.o. /ID# 207443 | Warsaw | Masovian Voivodeship | 02-758 | Poland |
| Royalderm Agnieszka Nawrocka /ID# 211015 | Warsaw | Masovian Voivodeship | 02-962 | Poland |
| ClinicMed Daniluk, Nowak Sp.j. /ID# 211112 | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Dermoklinika Medical Center /ID# 211026 | Lodz | Łódź Voivodeship | 90-436 | Poland |
| National Skin Centre /ID# 208775 | Singapore | Central Singapore | 308205 | Singapore |
| National University Hospital /ID# 208774 | Singapore | 119074 | Singapore |
| Singapore General Hospital /ID# 208776 | Singapore | 169608 | Singapore |
| Hospital Universitario de Bellvitge /ID# 207063 | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario Dr. Negrin /ID# 208969 | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Hospital de Manises /ID# 207062 | Manises | Valencia | 46940 | Spain |
| Complejo Hospitalario Universitario de Pontevedra /ID# 207139 | Pontevedra | 36071 | Spain |
| Hospital Universitario Arnau Vilanova /ID# 207065 | Valencia | 46015 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 207064 | Valencia | 46026 | Spain |
| Skanes Universitetssjukhus /ID# 206783 | Malmö | Skåne County | 214 28 | Sweden |
| Karolinska University Hospital /ID# 207909 | Stockholm | SE-17176 | Sweden |
| China Medical University Hosp /ID# 209770 | Taichung | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital /ID# 208309 | Taipei City | Taipei | 100 | Taiwan |
| Chung Shan Medical University /ID# 208311 | Taichung | 40201 | Taiwan |
| Taipei Municipal Wan Fang Hospital /ID# 209987 | Taipei | 116 | Taiwan |
| Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 210435 | Zaporizhzhya | Zaporizhzhia Oblast | 69063 | Ukraine |
| Kyiv City Clinical Skin and Venereal Hospital /ID# 210755 | Kyiv | 04209 | Ukraine |
| ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210434 | Rivne | 33028 | Ukraine |
| Royal Alex Childrens County Hospital /ID# 209709 | Brighton | Brighton And Hove | BN2 5BE | United Kingdom |
| Victoria Hospital /ID# 209853 | Kirkcaldy | Fife | KY2 5AH | United Kingdom |
| Royal Hospital for Children /ID# 210451 | Glasgow | Glasgow City | G51 4TF | United Kingdom |
| The Royal Free Hospital /ID# 208659 | London | London, City of | NW3 2QG | United Kingdom |
| Guy's and St Thomas' NHS Found /ID# 208881 | London | London, City of | SE1 9RT | United Kingdom |
| Cardiff & Vale University Health Board /ID# 209745 | Cardiff | Wales | CF14 4XN | United Kingdom |
| Blauvelt A, Simpson EL, Eyerich K, de Bruin-Weller M, Barbarot S, Lio PA, Hurst W, Tcherny-Lessenot S, Levy S, Bastian M. Benefit-risk profile comparison between dupilumab and upadacitinib: a structured benefit-risk assessment of the Heads Up trial. J Dermatolog Treat. 2026 Dec;37(1):2675726. doi: 10.1080/09546634.2026.2675726. Epub 2026 Jun 1. |
| 40457140 | Derived | Simpson EL, Silverberg JI, Prajapati VH, Eyerich K, Katoh N, Boguniewicz M, Guttman-Yassky E, Song EJ, Lee WJ, Teixeira HD, Wu T, Sancho Sanchez C, Vigna N, Calimlim BM, de Bruin-Weller M. Rapid Itch Improvement and Skin Clearance with Upadacitinib Versus Placebo (Measure Up 1 and Measure Up 2) and Versus Dupilumab (Heads Up): Results from Three Phase 3 Clinical Trials in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Aug;15(8):2061-2076. doi: 10.1007/s13555-025-01443-w. Epub 2025 Jun 2. |
| 39110139 | Derived | Blauvelt A, Eyerich K, Irvine AD, de Bruin-Weller M, Kwatra SG, Gooderham M, Kim B, Calimlim BM, Lee WJ, Raymundo EM, Liu Y, Ofori S, Platt AM, Silverberg JI. More Time Spent with Clear Skin and No Itch with Upadacitinib versus Dupilumab for Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2621-2630. doi: 10.1007/s13555-024-01242-9. Epub 2024 Aug 7. |
Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22. |
| COMPLETED |
|
| NOT COMPLETED |
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The intent-to-treat (ITT) population includes all randomized participants according to the treatment groups that they were randomized to.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dupilumab 300 mg EOW | Participants received a loading dose of 600 mg dupilumab by SC injection on Day 1 followed by 300 mg dupilumab SC EOW until Week 22 and placebo to upadacitinib orally QD up to Week 24. |
| BG001 | Upadacitinib 30 mg QD | Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Disease Severity | Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale:
| Count of Participants | Participants |
| |||||||||||||||
| Eczema Area and Severity Index (EASI) Score | EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Duration Since AD Diagnosis | Mean | Standard Deviation | years |
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| 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 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at 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 using an electronic hand-held device. Participants were asked to rate 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). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement. | Intent-to-treat population with non-missing Baseline and at least one post-baseline value; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded. | Posted | Least Squares Mean | Standard Error | percent change | Baseline (Week 0) to Week 16 |
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| Secondary | Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) 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 EASI Score (EASI 90) at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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| Secondary | Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at 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 using an electronic hand-held device. Participants were asked to rate 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). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement. | Intent-to-treat population with non-missing Baseline and at least one post-baseline value; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded. | Posted | Least Squares Mean | Standard Error | percent change | Baseline (Week 0) to Week 4 |
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| Secondary | Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Intent-to-treat population; Non-responder imputation while incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 2 |
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| Secondary | Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at 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 using an electronic hand-held device. Participants were asked to rate 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). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement. | Intent-to-treat population with non-missing Baseline and at least one post-baseline value; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded. | Posted | Least Squares Mean | Standard Error | percent change | Baseline (Week 0) to Week 1 |
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| Secondary | Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at 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 using an electronic hand-held device. Participants were asked to rate 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 population with Worst Pruritus NRS ≥ 4 at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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All-cause mortality was recorded from Day 1 up to 12 weeks after last injection (34 weeks). Treatment-emergent adverse events are from first dose of upadacitinib/dupilumab through 30 days following the last dose of upadacitinib or 84 days following the last dose of dupilumab (up to 34 weeks).
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 300 mg EOW | Participants received a loading dose of 600 mg dupilumab by SC injection on Day 1 followed by 300 mg dupilumab SC EOW until Week 22 and placebo to upadacitinib orally QD up to Week 24. | 0 | 331 | 7 | 331 | 134 | 331 |
| EG001 | Upadacitinib 30 mg QD | Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22. | 1 | 342 | 14 | 342 | 167 | 342 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| GLAUCOMA | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| INCARCERATED UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| FOOD ALLERGY | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| TYPE I HYPERSENSITIVITY | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| BETA HAEMOLYTIC STREPTOCOCCAL INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| ERYSIPELAS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| HERPES SIMPLEX | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| PELVIC ABSCESS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
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| PARATHYROID TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
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| INTENTIONAL SELF-INJURY | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| ABORTION INDUCED | Surgical and medical procedures | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONJUNCTIVITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| FOLLICULITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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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 | Nov 2, 2020 | Jan 10, 2022 | 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 |
|---|---|
| C000613732 | upadacitinib |
| C582203 | dupilumab |
Not provided
Not provided
Not provided
| ≥ 40 to < 65 years |
|
| ≥ 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian/Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Multiple |
|
| 4 (Severe) |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22.
|
|
|
Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22.
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22.
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
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