Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib for the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Upadacitinib

• Study Type: Interventional
• Enrollment (Actual): 475
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice /ID# 218755
    • Darlinghurst, New South Wales, Australia, 2010
      • The Skin Hospital /ID# 218753
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research /ID# 218754
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology - Melbourne /ID# 218751
  • Western Australia
    • Victoria Park, Western Australia, Australia, 6100
      • Burswood Dermatology /ID# 218752
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Kirk Barber Research, CA /ID# 218727
    • Calgary, Alberta, Canada, T2J 7E1
      • Duplicate_Dermatology Research Institute Inc. /ID# 218728
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc. /ID# 218725
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical Research /ID# 218726
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Dr. Wei Jing Loo Medicine Prof /ID# 218722
    • Markham, Ontario, Canada, L3P 1X3
      • Duplicate_Lynderm Research Inc. /ID# 218723
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research Inc. /ID# 218721
    • Toronto, Ontario, Canada, M2N 3A6
      • North York Research Inc /ID# 218729
    • Waterloo, Ontario, Canada, N2J 1C4
      • Duplicate_K. Papp Clinical Research /ID# 218730
  • Quebec
    • Saint-Jerome, Quebec, Canada, J7Z 7E2
      • Dre Angelique Gagne-Henley M.D. inc. /ID# 218724
• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Zagreb /ID# 218375
  • Zagrebacka Zupanija
    • Ivanic-Grad, Zagrebacka Zupanija, Croatia, 10310
      • Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove /ID# 214176
  • Jihlava, Czechia, 586 01
    • Nemocnice Jihlava, prispevkova organizace /ID# 214178
  • Ostrava, Czechia, 708 52
    • Fakultni Nemocnice Ostrava /ID# 214177
  • Praha, Czechia, 150 06
    • Duplicate_Duplicate_Fakultni Nemocnice v Motole /ID# 214179
• Finland
  • Mikkeli, Finland, 50100
    • Mikkeli Central Hospital /ID# 214629
  • Keski-Pohjanmaa
    • Kokkola, Keski-Pohjanmaa, Finland, 67200
      • Keski-pohjanmaa Central Hospital /ID# 214630
  • Pohjois-Pohjanmaa
    • Oulu, Pohjois-Pohjanmaa, Finland, 90220
      • Duplicate_Oulun yliopistollinen sairaala /ID# 214628
• France
  • Rouen, France, 76000
    • Hôpital Charles-Nicolle /ID# 218960
  • Toulouse, France, 31400
    • CHU Toulouse - Hopital Larrey /ID# 218958
  • Bouches-du-Rhone
    • Marseille CEDEX 05, Bouches-du-Rhone, France, 13385
      • AP-HM - Hopital de la Timone /ID# 218957
  • Marne
    • Reims, Marne, France, 51100
      • Polyclinique Courlancy /ID# 218955
  • Pays-de-la-Loire
    • Nantes, Pays-de-la-Loire, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 218959
• Germany
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover /ID# 214226
  • Munich, Germany, 81675
    • Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221
  • Brandenburg
    • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
      • Dermatologische Mahlow /ID# 214225
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Duplicate_Klinikum Darmstadt GmbH /ID# 214224
    • Frankfurt am Main, Hessen, Germany, 60590
      • Universitaetsklinikum Frankfurt /ID# 214223
  • Niedersachsen
    • Munster, Niedersachsen, Germany, 48149
      • Duplicate_Universitaetsklinikum Muenster /ID# 214222
• Hungary
  • Budapest, Hungary, 1135
    • Uno Medical Trials Kft /ID# 214987
  • Bekes
    • Oroshaza, Bekes, Hungary, 5900
      • Oroshazi Korhaz /ID# 214986
  • Somogy
    • Kaposvár, Somogy, Hungary, 7400
      • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984
• Ireland
  • Dublin
    • Elm Park, Dublin, Ireland, D04 T6F4
      • St Vincent's University Hospital /ID# 213558
• Israel
  • Haifa, Israel, 4941492
    • Rabin Medical Center /ID# 218521
  • HaDarom
    • Afula, HaDarom, Israel, 1834111
      • Duplicate_HaEmek Medical Center /ID# 218520
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 218522
• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095
  • Modena, Italy, 41124
    • Azienda Ospedaliero-Universitaria di Modena /ID# 214096
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas /ID# 215727
  • Roma
    • Rome, Roma, Italy, 00133
      • Fondazione PTV Policlinico Tor Vergata /ID# 214093
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Med Ctr /ID# 218882
  • Penang, Malaysia, 10450
    • Hospital Pulau Pinang /ID# 218878
  • Johor
    • Johor Bahru, Johor, Malaysia, 81100
      • Hospital Sultan Ismail /ID# 218881
    • Muar, Johor, Malaysia, 84000
      • Hospital Pakar Sultanah Fatimah /ID# 218877
  • Selangor
    • Kuala Lumpur, Selangor, Malaysia, 56000
      • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879
  • Wilayah Persekutuan Putrajaya
    • Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250
      • Hospital Putrajaya /ID# 218880
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen /ID# 218775
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht /ID# 218771
  • Noord-Brabant
    • Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
      • Bravis Ziekenhuis /ID# 218772
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Duplicate_Erasmus Medisch Centrum /ID# 218770
• New Zealand
  • Hamilton, New Zealand, 3204
    • Clinical Trials New Zealand /ID# 218690
  • Auckland
    • Grafotn, Auckland, New Zealand, 1010
      • Optimal Clinical Trials Ltd /ID# 218688
  • Wellington
    • Newtown, Wellington, New Zealand, 6021
      • Wellington Regional Hospital /ID# 218689
• Norway
  • Troms
    • Tromso, Troms, Norway, 9019
      • Duplicate_Universitetssykehuset N-Norge, Tromso /ID# 214634
• Poland
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-436
      • Dermoklinika Centrum Medyczne s.c. /ID# 214300
  • Malopolskie
    • Krakow, Malopolskie, Poland, 30-727
      • Duplicate_Pratia MCM Krakow /ID# 214303
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-953
      • Klinika Ambroziak Sp. z o.o. /ID# 214301
    • Warszawa, Mazowieckie, Poland, 02-962
      • Duplicate_Duplicate_Royalderm Agnieszka Nawrocka /ID# 214302
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-879
      • ClinicMed Daniluk, Nowak Sp.k. /ID# 214299
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital /ID# 219093
• Spain
  • Pontevedra, Spain, 36071
    • Complejo Hospitalario Universitario de Pontevedra /ID# 214255
  • Valencia, Spain, 46015
    • Hospital Universitario Arnau Vilanova /ID# 214254
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 214252
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Duplicate_Hospital Universitario de Bellvitge /ID# 214257
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
      • Hospital Universitario Dr. Negrin /ID# 214256
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Hospital de Manises /ID# 214258
• Taiwan
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital /ID# 218919
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 218409
  • Taipei, Taiwan, 116
    • Taipei Municipal Wan Fang Hospital /ID# 218918
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 218917
• Ukraine
  • Rivne, Ukraine, 33028
    • ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385
  • Kyivska Oblast
    • Kyiv, Kyivska Oblast, Ukraine, 04209
      • Kyiv City Clinical Skin and Venereal Hospital /ID# 218382
• United Kingdom
  • Fife
    • Kirkcaldy, Fife, United Kingdom, KY2 5AH
      • Victoria Hospital /ID# 213564
  • London, City Of
    • London, London, City Of, United Kingdom, NW3 2QG
      • Duplicate_The Royal Free London NHS Foundation Trust /ID# 213560
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0XH
      • NHS Greater Glasgow and Clyde /ID# 213561
  • West Sussex
    • Worthing, West Sussex, United Kingdom, BN11 2DH
      • University Hospitals Sussex NHS Foundation Trust /ID# 213562
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences /ID# 221021
  • California
    • Fountain Valley, California, United States, 92708-3701
      • Duplicate_First OC Dermatology Research Inc /ID# 218619
    • Fresno, California, United States, 93701-2302
      • UCSF Fresno /ID# 218453
    • Los Angeles, California, United States, 90025-7014
      • California Allergy and Asthma Medical Group /ID# 218635
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates /ID# 218637
    • Newport Beach, California, United States, 92660-7853
      • Dermatology Clinical Trials /ID# 218627
    • Sacramento, California, United States, 95816-3300
      • Duplicate_UC Davis Health /ID# 218582
    • San Diego, California, United States, 92103
      • Ucsd /Id# 218629
    • Santa Monica, California, United States, 90404-2102
      • Clinical Science Institute /ID# 218632
  • Florida
    • Miami, Florida, United States, 33173-3570
      • Miami Dermatology and Laser Institute /ID# 218664
    • Miami, Florida, United States, 33173
      • Florida International Rsrch cr /ID# 218663
    • Saint Petersburg, Florida, United States, 33705
      • GCP Research /ID# 218665
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida, Inc. /ID# 218438
  • Georgia
    • Albany, Georgia, United States, 31707-1282
      • Georgia Pollens Clinical Research Centers, Inc /ID# 218441
  • Illinois
    • Chicago, Illinois, United States, 60654-6903
      • Medical Dermatology Associates of Chicago /ID# 218551
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin, LLC /ID# 218478
  • Massachusetts
    • Quincy, Massachusetts, United States, 02169
      • Beacon Clinical Research, LLC /ID# 218636
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Duplicate_Michigan Center for Research Company /ID# 218577
    • Detroit, Michigan, United States, 48202-3046
      • Henry Ford Medical Center - New Center One /ID# 218575
  • Nebraska
    • Lincoln, Nebraska, United States, 68505-2343
      • Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC /ID# 218549
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center /ID# 218574
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74132
      • Southside Dermatology /ID# 218477
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Medical Research Center /ID# 218578
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center /ID# 218440
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Duplicate_Medical University of South Carolina /ID# 221072
  • Tennessee
    • Jackson, Tennessee, United States, 38305-2163
      • Clinical Research Solutions, LLC /ID# 218447
  • Texas
    • Austin, Texas, United States, 78759-4100
      • Orion Clinical Research /ID# 218565
    • Kerrville, Texas, United States, 78028-9640
      • Sante Clinical Research /ID# 218911
  • Virginia
    • Richmond, Virginia, United States, 23220-4459
      • Clinical Research Partners, LLC /ID# 218480
  • Washington
    • Spokane, Washington, United States, 99202
      • Duplicate_Premier Clinical Research /ID# 218583
  • West Virginia
    • South Charleston, West Virginia, United States, 25309
      • West Virginia Research Inst /ID# 218479

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.
• Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.

Exclusion Criteria:

• Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
• Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upadacitinib; Participants will be administered with upadacitinib once daily (QD)	Drug: Upadacitinib; Upadacitinib will be administered oral as tablet; Other Names: RINVOQ; ABT-494

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): September 11, 2023
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Upadacitinib; Atopic Dermatitis; RINVOQ; ABT-494
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Upadacitinib
• Other Study ID Numbers: M19-850; 2019-001227-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: 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/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes