A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

Study Overview

• Status: Completed
• Conditions: Crohn's Disease (CD)
• Intervention / Treatment: Drug: ABT-494

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • Duplicate_CHU de Liege /ID# 149912
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital /ID# 149873
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Duplicate_(G.I.R.I.) GI Research Institute Foundation /ID# 149878
  • Ontario
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates /ID# 149877
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 149871
• Czechia
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o. /ID# 149882
• Denmark
  • Hovedstaden
    • Hvidovre, Hovedstaden, Denmark, 2650
      • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890
  • Midtjylland
    • Aarhus N, Midtjylland, Denmark, 8200
      • Duplicate_Aarhus University Hospital /ID# 149919
• France
  • Meurthe-et-Moselle
    • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
      • CHRU Nancy - Hopitaux de Brabois /ID# 149896
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 149897
  • Somme
    • Amiens CEDEX 1, Somme, France, 80054
      • CHU Amiens-Picardie Site Sud /ID# 149921
• Germany
  • Berlin, Germany, 14050
    • DRK Kliniken Berlin Westend /ID# 149905
  • Muenster, Germany, 48155
    • Medizinisches Versorgungszentrum Portal 10 /ID# 149930
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936
• Hungary
  • Budapest, Hungary, 1124
    • Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907
• Israel
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 149942
  • HaMerkaz
    • Zerifin, HaMerkaz, Israel, 70300
      • Yitzhak Shamir Medical Center /ID# 149943
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 149945
• Italy
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • University of Catanzaro /ID# 149927
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 149958
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht /ID# 149933
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, locatie AMC /ID# 149932
• New Zealand
  • Otago, New Zealand, 9016
    • Dunedin Hospital /ID# 149964
• Norway
  • Oslo, Norway, 0440
    • Lovisenberg Diakonale Sykehus /ID# 149967
• Poland
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-302
      • Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-507
      • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 149978
• Romania
  • Timișoara, Romania, 300002
    • Cabinet Particular Policlinic Algomed /ID# 149993
• Slovakia
  • Nitriansky Kraj
    • Nitra, Nitriansky Kraj, Slovakia, 949 01
      • Duplicate_KM Management, spol. s.r.o. /ID# 149949
  • Presovsky Kraj
    • Prešov, Presovsky Kraj, Slovakia, 080 01
      • Gastro I., s.r.o. /ID# 149948
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 149997
  • A Coruna
    • Ferrol, A Coruna, Spain, 15405
      • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996
• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Duplicate_Manchester University NHS Foundation Trust /ID# 150006
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals NHS Foundation Trust /ID# 149963
• United States
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego Health System /ID# 150041
    • San Francisco, California, United States, 94143-2204
      • Univ California, San Francisco /ID# 149987
  • Florida
    • Gainesville, Florida, United States, 32610
      • Duplicate_University of Florida - Archer /ID# 150033
    • Hollywood, Florida, United States, 33021
      • The Ctr for Gastro Disorders /ID# 150012
    • Inverness, Florida, United States, 34452-4717
      • Nature Coast Clinical Research - Inverness /ID# 149975
  • Georgia
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia, LLC /ID# 149870
    • Marietta, Georgia, United States, 30060
      • GI Specialists of GA, PC /ID# 150015
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Duplicate_University of Louisville /ID# 149884
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Investigative Clinical Research /ID# 149886
    • Towson, Maryland, United States, 21204
      • Charm City Research Group /ID# 150040
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clin Res Inst of Michigan, LLC /ID# 150008
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 149894
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Research Institute /ID# 149888
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 149899
  • New York
    • Lake Success, New York, United States, 11042
      • NYU Langone Long Island Clinical Research Associates /ID# 149976
    • New York, New York, United States, 10021-4872
      • Weill Cornell Medicine/NYP /ID# 149895
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514-4220
      • Univ NC Chapel Hill /ID# 149982
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University Of Cincinnati Medical Center /ID# 149977
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC /ID# 150010
  • Texas
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants - Southlake /ID# 149869
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants - Southlake /ID# 149989
  • Utah
    • Orem, Utah, United States, 84058
      • Aspen Clinical Research /ID# 150020
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia /ID# 149881
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington /ID# 149988
    • Seattle, Washington, United States, 98101
      • Virginia Mason Hospital & Medical Center /ID# 150042
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research /ID# 149863

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participant must have completed Study M13-740 through Week 52.
• If female, participant must be postmenopausal, surgically sterile or on using a birth control method.

Exclusion Criteria:

• For any reason participant is considered by the investigator to be an unsuitable candidate
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upadacitinib (ABT-494) Dose A; Open label dose A once daily (QD)	Drug: ABT-494; Tablet: Oral; Other Names: RINVOQ; Upadacitinib
Experimental: Upadacitinib (ABT-494) Dose B; Open label dose B QD	Drug: ABT-494; Tablet: Oral; Other Names: RINVOQ; Upadacitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Remission	It is defined as the percentage of participants achieving clinical remission and endoscopic remission.	Up to Month 96
Percentage of Participants in Remission at Week 0 Who Maintain Remission	Remission is defined as participants achieving clinical remission and endoscopic remission.	Up to Month 96
Percentage of Participants Achieving Response	It is defined as the percentage of participants achieving clinical response and endoscopic response.	Up to Month 96
Percentage of Participants Achieving Clinical Remission	Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain.	Up to Month 96
Percentage of Participants Achieving Modified Clinical Remission	Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.	Up to Month 96
Percentage of Participants Achieving Enhanced Clinical Response	Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.	Up to Month 96
Percentage of Participants Achieving Clinical Response	Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.	Up to Month 96
Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.	Up to Month 96
Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission	Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.	Up to Month 96
Percentage of Participants Achieving Endoscopic Improvement	Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission.	Up to Month 96
Percentage of Participants Achieving Endoscopic Response	Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.	Up to Month 96
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission	It is defined as CDAI less than 150.	Up to Month 96
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response	CDAI response is defined as a reduction in CDAI by >= 70 from baseline of Study M13-740.	Up to Month 96
Percentage of Participants Achieving Enhanced CDAI Response	Enhanced CDAI response is defined as reduction in CDAI by >= 100 from baseline of Study M13-740.	Up to Month 96
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission	IBDQ remission is defined as IBDQ >= 170.	Up to Month 96
Percentage of Participants Achieving IBDQ Response	IBDQ response is defined as an increase in IBDQ score >= 16 point from Baseline of Study M13-740.	Up to Month 96
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free	Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free	Up to Month 96
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission	Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission	Up to Month 96
Percentage of Participants Achieving Remission and Normal C-Reactive Protein	Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission.	Up to Month 96

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

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): May 18, 2016
• Primary Completion (Actual): July 18, 2025
• Study Completion (Actual): July 18, 2025

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 23, 2016
• First Posted (Estimated): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Tolerability; Crohn's Disease; ABT-494
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Upadacitinib
• Other Study ID Numbers: M14-327; 2015-003759-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about 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; ANALYTIC_CODE; 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.: No