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

October 4, 2023 updated by: AbbVie

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 /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
        • 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 1X2
        • 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
        • 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
        • 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
        • 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
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt /ID# 214224
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover /ID# 214226
      • Mahlow, Germany, 15831
        • Dermatologische Gemeinschaftspraxis Mahlow /ID# 214225
      • Munich, Germany, 81675
        • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 214223
    • Niedersachsen
      • Munster, Niedersachsen, Germany, 48149
        • 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
      • Afula, Israel, 1834111
        • HaEmek Medical Center /ID# 218520
      • Petakh Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 218521
    • 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
        • Erasmus Medisch Centrum /ID# 218770
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Clinical Trials NZ /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
        • 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
        • Pratia MCM Krakow /ID# 214303
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-962
        • Royalderm Agnieszka Nawrocka /ID# 214302
      • Warszawa, Mazowieckie, Poland, 02-953
        • Klinika Ambroziak Sp. z o.o. /ID# 214301
    • 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
        • 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 City, 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
      • Worthing, United Kingdom, BN11 2DH
        • University Hospitals Sussex NHS Foundation Trust /ID# 213562
    • Fife
      • Kirkcaldy, Fife, United Kingdom, KY2 5AH
        • Victoria Hospital /ID# 213564
    • London, City Of
      • London, London, City Of, United Kingdom, NW3 2QG
        • The Royal Free London NHS Foundation Trust /ID# 213560
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde /ID# 213561
  • 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
        • 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
        • 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
        • Michigan Center for Research Company /ID# 218577
      • Detroit, Michigan, United States, 48202-3046
        • Henry Ford Medical Center /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, 97223
        • Oregon Medical Res Center PC /ID# 218440
      • Portland, Oregon, United States, 97239
        • Oregon Medical Research Center /ID# 218578
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • 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
        • Premier Clinical Research /ID# 218583
    • West Virginia
      • South Charleston, West Virginia, United States, 25309
        • West Virginia Research Inst /ID# 218479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 Adverse Events
Time Frame: From Baseline to 30 days following last dose of study drug (Week 52)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
From Baseline to 30 days following last dose of study drug (Week 52)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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