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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001227-12 | EudraCT Number |
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This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.
Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib | Experimental | Participants will be administered with upadacitinib once daily (QD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Drug | Upadacitinib will be administered oral as tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib. | UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days). |
| Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Treatment-emergent adverse events were monitored throughout the study to identify any adverse events of special interest that may indicate a trend or risk to participants. AESIs are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Study M16-046 for the UPA/UPA arm or Study M19-850 for the DUPI/UPA arm through 30 days following the last dose of upadacitinib. | UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days). |
| Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Clinical laboratory test values are considered PCI if they meet either the lower-limit or higher-limit PCI criteria defined in the categories below. Percentage of participants with PCI laboratory values are summarized for hematology and chemistry. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. xULN = Times upper limit of the normal range. | From Baseline to 30 days following last dose of study drug (Week 52) |
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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 |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences /ID# 221021 | Little Rock | Arkansas | 72205 | United States | ||
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| 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, 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 originally randomized to upadacitinib or dupilumab in Lead-In Study M16-046 and continued on into this Long-Term Extension Study M19-850.
The ITT Population consists of all enrolled participants who received at least 1 dose of study drug in this study and is used for all efficacy analyses. The Safety Population is the same as the ITT Population and is used for all safety analyses.
A total of 475 participants were enrolled at 114 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 US).
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| ID | Title | Description |
|---|---|---|
| FG000 | DUPI 300mg to UPA 30mg | All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group. |
| FG001 |
| 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 | Jan 7, 2021 | Sep 5, 2024 |
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| Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | PCI post-baseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting], pulse rate [sitting], and weight. Only those categories where at least 1 person had a non-PCI value at Baseline and met the PCI criterion at least once during post-baseline are reported. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. | From Baseline to 30 days following last dose of study drug (Week 52) |
| Duplicate_First OC Dermatology Research Inc /ID# 218619 |
| Fountain Valley |
| California |
| 92708-3701 |
| United States |
| UCSF Fresno /ID# 218453 | Fresno | California | 93701-2302 | United States |
| California Allergy and Asthma Medical Group /ID# 218635 | Los Angeles | California | 90025-7014 | United States |
| Dermatology Research Associates /ID# 218637 | Los Angeles | California | 90045 | United States |
| Dermatology Clinical Trials /ID# 218627 | Newport Beach | California | 92660-7853 | United States |
| Duplicate_UC Davis Health /ID# 218582 | Sacramento | California | 95816-3300 | United States |
| Ucsd /Id# 218629 | San Diego | California | 92103 | United States |
| Clinical Science Institute /ID# 218632 | Santa Monica | California | 90404-2102 | United States |
| Miami Dermatology and Laser Institute /ID# 218664 | Miami | Florida | 33173-3570 | United States |
| Florida International Rsrch cr /ID# 218663 | Miami | Florida | 33173 | United States |
| GCP Research /ID# 218665 | St. Petersburg | Florida | 33705 | United States |
| Clinical Research Trials of Florida, Inc. /ID# 218438 | Tampa | Florida | 33607 | United States |
| Georgia Pollens Clinical Research Centers, Inc /ID# 218441 | Albany | Georgia | 31707-1282 | United States |
| Medical Dermatology Associates of Chicago /ID# 218551 | Chicago | Illinois | 60654-6903 | United States |
| Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552 | Normal | Illinois | 61761 | United States |
| Dawes Fretzin, LLC /ID# 218478 | Indianapolis | Indiana | 46256 | United States |
| Beacon Clinical Research, LLC /ID# 218636 | Quincy | Massachusetts | 02169 | United States |
| Duplicate_Michigan Center for Research Company /ID# 218577 | Clarkston | Michigan | 48346 | United States |
| Henry Ford Medical Center - New Center One /ID# 218575 | Detroit | Michigan | 48202-3046 | United States |
| Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548 | Lincoln | Nebraska | 68505-2343 | United States |
| Skin Specialists, PC /ID# 218549 | Omaha | Nebraska | 68144 | United States |
| University Hospitals Case Medical Center /ID# 218574 | Cleveland | Ohio | 44106 | United States |
| Southside Dermatology /ID# 218477 | Tulsa | Oklahoma | 74132 | United States |
| Oregon Medical Research Center /ID# 218440 | Portland | Oregon | 97223 | United States |
| Oregon Medical Research Center /ID# 218578 | Portland | Oregon | 97239 | United States |
| Duplicate_Medical University of South Carolina /ID# 221072 | Charleston | South Carolina | 29425 | United States |
| Clinical Research Solutions, LLC /ID# 218447 | Jackson | Tennessee | 38305-2163 | United States |
| Orion Clinical Research /ID# 218565 | Austin | Texas | 78759-4100 | United States |
| Sante Clinical Research /ID# 218911 | Kerrville | Texas | 78028-9640 | United States |
| Clinical Research Partners, LLC /ID# 218480 | Richmond | Virginia | 23220-4459 | United States |
| Duplicate_Premier Clinical Research /ID# 218583 | Spokane | Washington | 99202 | United States |
| West Virginia Research Inst /ID# 218479 | South Charleston | West Virginia | 25309 | United States |
| Holdsworth House Medical Practice /ID# 218755 | Darlinghurst | New South Wales | 2010 | Australia |
| The Skin Hospital /ID# 218753 | Darlinghurst | New South Wales | 2010 | Australia |
| Veracity Clinical Research /ID# 218754 | Woolloongabba | Queensland | 4102 | Australia |
| Sinclair Dermatology - Melbourne /ID# 218751 | East Melbourne | Victoria | 3002 | Australia |
| Burswood Dermatology /ID# 218752 | Victoria Park | Western Australia | 6100 | Australia |
| Kirk Barber Research, CA /ID# 218727 | Calgary | Alberta | T2G 1B1 | Canada |
| Duplicate_Dermatology Research Institute Inc. /ID# 218728 | Calgary | Alberta | T2J 7E1 | Canada |
| Dr. Chih-ho Hong Medical Inc. /ID# 218725 | Surrey | British Columbia | V3R 6A7 | Canada |
| Enverus Medical Research /ID# 218726 | Surrey | British Columbia | V3V 0C6 | Canada |
| Dr. Wei Jing Loo Medicine Prof /ID# 218722 | London | Ontario | N6H 5L5 | Canada |
| Duplicate_Lynderm Research Inc. /ID# 218723 | Markham | Ontario | L3P 1X3 | Canada |
| DermEdge Research Inc. /ID# 218721 | Mississauga | Ontario | L4Y 4C5 | Canada |
| North York Research Inc /ID# 218729 | Toronto | Ontario | M2N 3A6 | Canada |
| Duplicate_K. Papp Clinical Research /ID# 218730 | Waterloo | Ontario | N2J 1C4 | Canada |
| Dre Angelique Gagne-Henley M.D. inc. /ID# 218724 | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinicki bolnicki centar Zagreb /ID# 218375 | Zagreb | City of Zagreb | 10000 | Croatia |
| Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376 | Ivanić-Grad | Zagreb County | 10310 | Croatia |
| Fakultni nemocnice Hradec Kralove /ID# 214176 | Hradec Králové | 500 05 | Czechia |
| Nemocnice Jihlava, prispevkova organizace /ID# 214178 | Jihlava | 586 01 | Czechia |
| Fakultni Nemocnice Ostrava /ID# 214177 | Ostrava | 708 52 | Czechia |
| Duplicate_Duplicate_Fakultni Nemocnice v Motole /ID# 214179 | Prague | 150 06 | Czechia |
| Keski-pohjanmaa Central Hospital /ID# 214630 | Kokkola | Keski-Pohjanmaa | 67200 | Finland |
| Duplicate_Oulun yliopistollinen sairaala /ID# 214628 | Oulu | North Ostrobothnia | 90220 | Finland |
| Mikkeli Central Hospital /ID# 214629 | Mikkeli | 50100 | Finland |
| AP-HM - Hopital de la Timone /ID# 218957 | Marseille | Bouches-du-Rhone | 13385 | France |
| Polyclinique Courlancy /ID# 218955 | Reims | Marne | 51100 | France |
| CHU de Nantes, Hotel Dieu -HME /ID# 218959 | Nantes | Pays de la Loire Region | 44000 | France |
| Hôpital Charles-Nicolle /ID# 218960 | Rouen | 76000 | France |
| CHU Toulouse - Hopital Larrey /ID# 218958 | Toulouse | 31400 | France |
| Dermatologische Mahlow /ID# 214225 | Blankenfelde-Mahlow | Brandenburg | 15831 | Germany |
| Duplicate_Klinikum Darmstadt GmbH /ID# 214224 | Darmstadt | Hesse | 64283 | Germany |
| Universitaetsklinikum Frankfurt /ID# 214223 | Frankfurt am Main | Hesse | 60590 | Germany |
| Duplicate_Universitaetsklinikum Muenster /ID# 214222 | Munster | Lower Saxony | 48149 | Germany |
| Medizinische Hochschule Hannover /ID# 214226 | Hanover | 30625 | Germany |
| Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221 | Munich | 81675 | Germany |
| Oroshazi Korhaz /ID# 214986 | Orosháza | Bekes County | 5900 | Hungary |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984 | Kaposvár | Somogy County | 7400 | Hungary |
| Uno Medical Trials Kft /ID# 214987 | Budapest | 1135 | Hungary |
| St Vincent's University Hospital /ID# 213558 | Elm Park | Dublin | D04 T6F4 | Ireland |
| Duplicate_HaEmek Medical Center /ID# 218520 | Afula | Southern District | 1834111 | Israel |
| The Chaim Sheba Medical Center /ID# 218522 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Rabin Medical Center /ID# 218521 | Haifa | 4941492 | Israel |
| Istituto Clinico Humanitas /ID# 215727 | Rozzano | Milano | 20089 | Italy |
| Fondazione PTV Policlinico Tor Vergata /ID# 214093 | Rome | Roma | 00133 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095 | Milan | 20122 | Italy |
| Azienda Ospedaliero-Universitaria di Modena /ID# 214096 | Modena | 41124 | Italy |
| Hospital Sultan Ismail /ID# 218881 | Johor Bahru | Johor | 81100 | Malaysia |
| Hospital Pakar Sultanah Fatimah /ID# 218877 | Muar town | Johor | 84000 | Malaysia |
| Hospital Putrajaya /ID# 218880 | Putrajaya | Putrajaya | 62250 | Malaysia |
| Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879 | Kuala Lumpur | Selangor | 56000 | Malaysia |
| Hospital Pulau Pinang /ID# 218878 | George Town | 10450 | Malaysia |
| University Malaya Med Ctr /ID# 218882 | Kuala Lumpur | 59100 | Malaysia |
| Bravis Ziekenhuis /ID# 218772 | Bergen op Zoom | North Brabant | 4624 VT | Netherlands |
| Duplicate_Erasmus Medisch Centrum /ID# 218770 | Rotterdam | South Holland | 3015 GD | Netherlands |
| Universitair Medisch Centrum Groningen /ID# 218775 | Groningen | 9713 GZ | Netherlands |
| Universitair Medisch Centrum Utrecht /ID# 218771 | Utrecht | 3584 CX | Netherlands |
| Optimal Clinical Trials Ltd /ID# 218688 | Grafotn | Auckland | 1010 | New Zealand |
| Wellington Regional Hospital /ID# 218689 | Newtown | Wellington Region | 6021 | New Zealand |
| Clinical Trials New Zealand /ID# 218690 | Hamilton | 3204 | New Zealand |
| Duplicate_Universitetssykehuset N-Norge, Tromso /ID# 214634 | Tromsø | Troms | 9019 | Norway |
| Duplicate_Pratia MCM Krakow /ID# 214303 | Krakow | Lesser Poland Voivodeship | 30-727 | Poland |
| Klinika Ambroziak Sp. z o.o. /ID# 214301 | Warsaw | Masovian Voivodeship | 02-953 | Poland |
| Duplicate_Duplicate_Royalderm Agnieszka Nawrocka /ID# 214302 | Warsaw | Masovian Voivodeship | 02-962 | Poland |
| ClinicMed Daniluk, Nowak Sp.k. /ID# 214299 | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Dermoklinika Centrum Medyczne s.c. /ID# 214300 | Lodz | Łódź Voivodeship | 90-436 | Poland |
| National University Hospital /ID# 219093 | Singapore | 119074 | Singapore |
| Duplicate_Hospital Universitario de Bellvitge /ID# 214257 | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario Dr. Negrin /ID# 214256 | Las Palmas de Gran Canaria | Las Palmas | 35019 | Spain |
| Hospital de Manises /ID# 214258 | Manises | Valencia | 46940 | Spain |
| Complejo Hospitalario Universitario de Pontevedra /ID# 214255 | Pontevedra | 36071 | Spain |
| Hospital Universitario Arnau Vilanova /ID# 214254 | Valencia | 46015 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 214252 | Valencia | 46026 | Spain |
| National Taiwan University Hospital /ID# 218917 | Taipei City | Taipei | 100 | Taiwan |
| Chung Shan Medical University Hospital /ID# 218919 | Taichung | 40201 | Taiwan |
| China Medical University Hospital /ID# 218409 | Taichung | 40447 | Taiwan |
| Taipei Municipal Wan Fang Hospital /ID# 218918 | Taipei | 116 | Taiwan |
| Kyiv City Clinical Skin and Venereal Hospital /ID# 218382 | Kyiv | Kyivska Oblast | 04209 | Ukraine |
| ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385 | Rivne | 33028 | Ukraine |
| Victoria Hospital /ID# 213564 | Kirkcaldy | Fife | KY2 5AH | United Kingdom |
| Duplicate_The Royal Free London NHS Foundation Trust /ID# 213560 | London | London, City of | NW3 2QG | United Kingdom |
| NHS Greater Glasgow and Clyde /ID# 213561 | Glasgow | Scotland | G12 0XH | United Kingdom |
| University Hospitals Sussex NHS Foundation Trust /ID# 213562 | Worthing | West Sussex | BN11 2DH | United Kingdom |
| UPA 30mg to UPA 30mg |
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Baseline visit for this study was the Week 24 visit of Parent Study M16-046.
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| ID | Title | Description |
|---|---|---|
| BG000 | DUPI 300mg to UPA 30mg | All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group. |
| BG001 | UPA 30mg to UPA 30mg | All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group. |
| 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 |
|
| 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 | Number of Participants With Treatment-Emergent Adverse Events | Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib. | The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier. | Posted | Count of Participants | Participants | UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days). |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Treatment-emergent adverse events were monitored throughout the study to identify any adverse events of special interest that may indicate a trend or risk to participants. AESIs are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Study M16-046 for the UPA/UPA arm or Study M19-850 for the DUPI/UPA arm through 30 days following the last dose of upadacitinib. | The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier. | Posted | Count of Participants | Participants | UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days). |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Clinical laboratory test values are considered PCI if they meet either the lower-limit or higher-limit PCI criteria defined in the categories below. Percentage of participants with PCI laboratory values are summarized for hematology and chemistry. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. xULN = Times upper limit of the normal range. | The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier. | Posted | Number | percentage of participants | From Baseline to 30 days following last dose of study drug (Week 52) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | PCI post-baseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting], pulse rate [sitting], and weight. Only those categories where at least 1 person had a non-PCI value at Baseline and met the PCI criterion at least once during post-baseline are reported. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. | The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier. | Posted | Number | percentage of participants | From Baseline to 30 days following last dose of study drug (Week 52) |
|
All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UPA 30mg to UPA 30mg | All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group. | 1 | 236 | 13 | 236 | 154 | 236 |
| EG001 | DUPI 300mg to UPA 30mg | All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group. | 0 | 239 | 14 | 239 | 149 | 239 |
| EG002 | Total | All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group and participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group. | 1 | 475 | 27 | 475 | 303 | 475 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PANCREATITIS | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| FOOD ALLERGY | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ABSCESS JAW | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| BONE TUBERCULOSIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| BULLOUS IMPETIGO | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| ECZEMA HERPETICUM | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| ERYSIPELAS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| PERICHONDRITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| PILONIDAL DISEASE | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
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| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| ADNEXAL TORSION | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
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| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
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| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| ABORTION INDUCED | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
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| ESSENTIAL HYPERTENSION | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| HERPES SIMPLEX | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| HERPES ZOSTER | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
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| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 25.1 | 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 | Aug 1, 2023 | Sep 5, 2024 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
Not provided
| ≥ 40 to < 65 years |
|
| ≥ 65 years |
|
| 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 |
|
| TEAE leading to discontinuation of study drug |
|
|
|
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
|
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group. |
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