A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
NCT ID: NCT02782663
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2016-05-18
2025-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Upadacitinib (ABT-494) Dose A
Open label dose A once daily (QD)
ABT-494
Tablet: Oral
Upadacitinib (ABT-494) Dose B
Open label dose B QD
ABT-494
Tablet: Oral
Interventions
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ABT-494
Tablet: Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If female, participant must be postmenopausal, surgically sterile or on using a birth control method.
Exclusion Criteria
* Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
* Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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UC San Diego Health System /ID# 150041
La Jolla, California, United States
Univ California, San Francisco /ID# 149987
San Francisco, California, United States
Duplicate_University of Florida - Archer /ID# 150033
Gainesville, Florida, United States
The Ctr for Gastro Disorders /ID# 150012
Hollywood, Florida, United States
Nature Coast Clinical Research - Inverness /ID# 149975
Inverness, Florida, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 149870
Macon, Georgia, United States
GI Specialists of GA, PC /ID# 150015
Marietta, Georgia, United States
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900
Topeka, Kansas, United States
Duplicate_University of Louisville /ID# 149884
Louisville, Kentucky, United States
Investigative Clinical Research /ID# 149886
Annapolis, Maryland, United States
Charm City Research Group /ID# 150040
Towson, Maryland, United States
Clin Res Inst of Michigan, LLC /ID# 150008
Chesterfield, Michigan, United States
Mayo Clinic - Rochester /ID# 149894
Rochester, Minnesota, United States
Kansas City Research Institute /ID# 149888
Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 149899
St Louis, Missouri, United States
NYU Langone Long Island Clinical Research Associates /ID# 149976
Lake Success, New York, United States
Weill Cornell Medicine/NYP /ID# 149895
New York, New York, United States
Univ NC Chapel Hill /ID# 149982
Chapel Hill, North Carolina, United States
University Of Cincinnati Medical Center /ID# 149977
Cincinnati, Ohio, United States
Options Health Research, LLC /ID# 150010
Tulsa, Oklahoma, United States
Texas Digestive Disease Consultants - Southlake /ID# 149869
Southlake, Texas, United States
Texas Digestive Disease Consultants - Southlake /ID# 149989
Southlake, Texas, United States
Aspen Clinical Research /ID# 150020
Orem, Utah, United States
University of Virginia /ID# 149881
Charlottesville, Virginia, United States
Virginia Mason Hospital & Medical Center /ID# 150042
Seattle, Washington, United States
University of Washington /ID# 149988
Seattle, Washington, United States
Wisconsin Center for Advanced Research /ID# 149863
Milwaukee, Wisconsin, United States
Duplicate_CHU de Liege /ID# 149912
Liège, , Belgium
University of Alberta Hospital /ID# 149873
Edmonton, Alberta, Canada
University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876
Vancouver, British Columbia, Canada
Duplicate_(G.I.R.I.) GI Research Institute Foundation /ID# 149878
Vancouver, British Columbia, Canada
Toronto Digestive Disease Associates /ID# 149877
Vaughan, Ontario, Canada
Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 149871
Montreal, Quebec, Canada
Hepato-Gastroenterologie HK, s.r.o. /ID# 149882
Hradec Králové, , Czechia
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890
Hvidovre, Capital Region, Denmark
Duplicate_Aarhus University Hospital /ID# 149919
Aarhus N, Central Jutland, Denmark
CHRU Nancy - Hopitaux de Brabois /ID# 149896
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHRU Lille - Hopital Claude Huriez /ID# 149897
Lille, Nord, France
CHU Amiens-Picardie Site Sud /ID# 149921
Amiens, Somme, France
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936
Kiel, Schleswig-Holstein, Germany
DRK Kliniken Berlin Westend /ID# 149905
Berlin, , Germany
Medizinisches Versorgungszentrum Portal 10 /ID# 149930
Münster, , Germany
Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907
Budapest, , Hungary
Yitzhak Shamir Medical Center /ID# 149943
Ẕerifin, Central District, Israel
The Chaim Sheba Medical Center /ID# 149945
Ramat Gan, Tel Aviv, Israel
Rabin Medical Center /ID# 149942
Petah Tikva, , Israel
University of Catanzaro /ID# 149927
Catanzaro, Calabria, Italy
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 149958
Bologna, Emilia-Romagna, Italy
Amsterdam UMC, locatie AMC /ID# 149932
Amsterdam, North Holland, Netherlands
Universitair Medisch Centrum Utrecht /ID# 149933
Utrecht, , Netherlands
Dunedin Hospital /ID# 149964
Otago, Otago, New Zealand
Lovisenberg Diakonale Sykehus /ID# 149967
Oslo, , Norway
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 149978
Warsaw, Masovian Voivodeship, Poland
Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979
Lodz, Łódź Voivodeship, Poland
Cabinet Particular Policlinic Algomed /ID# 149993
Timișoara, , Romania
Duplicate_KM Management, spol. s.r.o. /ID# 149949
Nitra, Nitra Region, Slovakia
Gastro I., s.r.o. /ID# 149948
Prešov, Presov, Slovakia
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996
Ferrol, A Coruna, Spain
Hospital Universitario La Paz /ID# 149997
Madrid, , Spain
Oxford University Hospitals NHS Foundation Trust /ID# 149963
Oxford, Oxfordshire, United Kingdom
Duplicate_Manchester University NHS Foundation Trust /ID# 150006
Manchester, , United Kingdom
Countries
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References
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D'Haens G, Panes J, Louis E, Lacerda A, Zhou Q, Liu J, Loftus EV Jr. Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2337-2346.e3. doi: 10.1016/j.cgh.2021.12.030. Epub 2021 Dec 27.
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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2015-003759-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-327
Identifier Type: -
Identifier Source: org_study_id
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