Clinical trial NCT04195698: Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Upadacitinib
ABT-494
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: 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).
measure: Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
timeFrame: 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).
measure: Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
timeFrame: From Baseline to 30 days following last dose of study drug (Week 52)
measure: Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
timeFrame: From Baseline to 30 days following last dose of study drug (Week 52)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences /ID# 221021
state: Arkansas
city: Fountain Valley
country: United States
facility: Duplicate_First OC Dermatology Research Inc /ID# 218619
state: California
city: Fresno
country: United States
facility: UCSF Fresno /ID# 218453
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group /ID# 218635
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates /ID# 218637
state: California
city: Newport Beach
country: United States
facility: Dermatology Clinical Trials /ID# 218627
state: California
city: Sacramento
country: United States
facility: Duplicate_UC Davis Health /ID# 218582
state: California
city: San Diego
country: United States
facility: Ucsd /Id# 218629
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute /ID# 218632
state: California
city: Miami
country: United States
facility: Miami Dermatology and Laser Institute /ID# 218664
state: Florida
city: Miami
country: United States
facility: Florida International Rsrch cr /ID# 218663
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research /ID# 218665
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc. /ID# 218438
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc /ID# 218441
state: Georgia
city: Chicago
country: United States
facility: Medical Dermatology Associates of Chicago /ID# 218551
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 218478
state: Indiana
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC /ID# 218636
state: Massachusetts
city: Clarkston
country: United States
facility: Duplicate_Michigan Center for Research Company /ID# 218577
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One /ID# 218575
state: Michigan
city: Lincoln
country: United States
facility: Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548
state: Nebraska
city: Omaha
country: United States
facility: Skin Specialists, PC /ID# 218549
state: Nebraska
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center /ID# 218574
state: Ohio
city: Tulsa
country: United States
facility: Southside Dermatology /ID# 218477
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center /ID# 218440
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center /ID# 218578
state: Oregon
city: Charleston
country: United States
facility: Duplicate_Medical University of South Carolina /ID# 221072
state: South Carolina
city: Jackson
country: United States
facility: Clinical Research Solutions, LLC /ID# 218447
state: Tennessee
city: Austin
country: United States
facility: Orion Clinical Research /ID# 218565
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research /ID# 218911
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners, LLC /ID# 218480
state: Virginia
city: Spokane
country: United States
facility: Duplicate_Premier Clinical Research /ID# 218583
state: Washington
city: South Charleston
country: United States
facility: West Virginia Research Inst /ID# 218479
state: West Virginia
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice /ID# 218755
state: New South Wales
city: Darlinghurst
country: Australia
facility: The Skin Hospital /ID# 218753
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research /ID# 218754
state: Queensland
city: East Melbourne
country: Australia
facility: Sinclair Dermatology - Melbourne /ID# 218751
state: Victoria
city: Victoria Park
country: Australia
facility: Burswood Dermatology /ID# 218752
state: Western Australia
city: Calgary
country: Canada
facility: Kirk Barber Research, CA /ID# 218727
state: Alberta
city: Calgary
country: Canada
facility: Duplicate_Dermatology Research Institute Inc. /ID# 218728
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 218725
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research /ID# 218726
state: British Columbia
city: London
country: Canada
facility: Dr. Wei Jing Loo Medicine Prof /ID# 218722
state: Ontario
city: Markham
country: Canada
facility: Duplicate_Lynderm Research Inc. /ID# 218723
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Inc. /ID# 218721
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc /ID# 218729
state: Ontario
city: Waterloo
country: Canada
facility: Duplicate_K. Papp Clinical Research /ID# 218730
state: Ontario
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 218724
state: Quebec
city: Zagreb
country: Croatia
facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 218375
state: Grad Zagreb
city: Ivanic-Grad
country: Croatia
facility: Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376
state: Zagrebacka Zupanija
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove /ID# 214176
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava, prispevkova organizace /ID# 214178
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava /ID# 214177
city: Praha
country: Czechia
facility: Duplicate_Duplicate_Fakultni Nemocnice v Motole /ID# 214179
city: Kokkola
country: Finland
facility: Keski-pohjanmaa Central Hospital /ID# 214630
state: Keski-Pohjanmaa
city: Oulu
country: Finland
facility: Duplicate_Oulun yliopistollinen sairaala /ID# 214628
state: Pohjois-Pohjanmaa
city: Mikkeli
country: Finland
facility: Mikkeli Central Hospital /ID# 214629
city: Marseille CEDEX 05
country: France
facility: AP-HM - Hopital de la Timone /ID# 218957
state: Bouches-du-Rhone
city: Reims
country: France
facility: Polyclinique Courlancy /ID# 218955
state: Marne
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 218959
state: Pays-de-la-Loire
city: Rouen
country: France
facility: Hôpital Charles-Nicolle /ID# 218960
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Larrey /ID# 218958
city: Blankenfelde-Mahlow
country: Germany
facility: Dermatologische Mahlow /ID# 214225
state: Brandenburg
city: Darmstadt
country: Germany
facility: Duplicate_Klinikum Darmstadt GmbH /ID# 214224
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 214223
state: Hessen
city: Munster
country: Germany
facility: Duplicate_Universitaetsklinikum Muenster /ID# 214222
state: Niedersachsen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 214226
city: Munich
country: Germany
facility: Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221
city: Oroshaza
country: Hungary
facility: Oroshazi Korhaz /ID# 214986
state: Bekes
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984
state: Somogy
city: Budapest
country: Hungary
facility: Uno Medical Trials Kft /ID# 214987
city: Elm Park
country: Ireland
facility: St Vincent's University Hospital /ID# 213558
state: Dublin
city: Afula
country: Israel
facility: Duplicate_HaEmek Medical Center /ID# 218520
state: HaDarom
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 218522
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 218521
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas /ID# 215727
state: Milano
city: Rome
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata /ID# 214093
state: Roma
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 214096
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail /ID# 218881
state: Johor
city: Muar
country: Malaysia
facility: Hospital Pakar Sultanah Fatimah /ID# 218877
state: Johor
city: Kuala Lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879
state: Selangor
city: Putrajaya
country: Malaysia
facility: Hospital Putrajaya /ID# 218880
state: Wilayah Persekutuan Putrajaya
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Med Ctr /ID# 218882
city: Penang
country: Malaysia
facility: Hospital Pulau Pinang /ID# 218878
city: Bergen op Zoom
country: Netherlands
facility: Bravis Ziekenhuis /ID# 218772
state: Noord-Brabant
city: Rotterdam
country: Netherlands
facility: Duplicate_Erasmus Medisch Centrum /ID# 218770
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 218775
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht /ID# 218771
city: Grafotn
country: New Zealand
facility: Optimal Clinical Trials Ltd /ID# 218688
state: Auckland
city: Newtown
country: New Zealand
facility: Wellington Regional Hospital /ID# 218689
state: Wellington
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand /ID# 218690
city: Tromso
country: Norway
facility: Duplicate_Universitetssykehuset N-Norge, Tromso /ID# 214634
state: Troms
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne s.c. /ID# 214300
state: Lodzkie
city: Krakow
country: Poland
facility: Duplicate_Pratia MCM Krakow /ID# 214303
state: Malopolskie
city: Warszawa
country: Poland
facility: Klinika Ambroziak Sp. z o.o. /ID# 214301
state: Mazowieckie
city: Warszawa
country: Poland
facility: Duplicate_Duplicate_Royalderm Agnieszka Nawrocka /ID# 214302
state: Mazowieckie
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Sp.k. /ID# 214299
state: Podlaskie
city: Singapore
country: Singapore
facility: National University Hospital /ID# 219093
city: L'Hospitalet de Llobregat
country: Spain
facility: Duplicate_Hospital Universitario de Bellvitge /ID# 214257
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Dr. Negrin /ID# 214256
state: Las Palmas
city: Manises
country: Spain
facility: Hospital de Manises /ID# 214258
state: Valencia
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra /ID# 214255
city: Valencia
country: Spain
facility: Hospital Universitario Arnau Vilanova /ID# 214254
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 214252
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 218917
state: Taipei
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital /ID# 218919
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 218409
city: Taipei
country: Taiwan
facility: Taipei Municipal Wan Fang Hospital /ID# 218918
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Skin and Venereal Hospital /ID# 218382
state: Kyivska Oblast
city: Rivne
country: Ukraine
facility: ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385
city: Kirkcaldy
country: United Kingdom
facility: Victoria Hospital /ID# 213564
state: Fife
city: London
country: United Kingdom
facility: Duplicate_The Royal Free London NHS Foundation Trust /ID# 213560
state: London, City Of
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 213561
state: Scotland
city: Worthing
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust /ID# 213562
state: West Sussex
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: