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

NCT02782663 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: M14-3272015-003759-23
• Study Type: interventional
• Target: 107
• Locations: 18 countries
• Sites: 61

Brief Summary

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

Conditions

Crohn's Disease (CD)

Keywords

Crohn's Disease; Efficacy; Safety; Tolerability; ABT-494

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (2)

Upadacitinib (ABT-494) Dose A

EXPERIMENTAL

Open label dose A once daily (QD)

Drug: ABT-494

Upadacitinib (ABT-494) Dose B

EXPERIMENTAL

Open label dose B QD

Drug: ABT-494

Interventions

ABT-494 DRUG

Tablet: Oral

Also known as: Upadacitinib, RINVOQ

Upadacitinib (ABT-494) Dose A; Upadacitinib (ABT-494) Dose B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (61)

UC San Diego Health System /ID# 150041

La Jolla, California, 92037, United States

Location

Univ California, San Francisco /ID# 149987

San Francisco, California, 94143-2204, United States

Location

Duplicate_University of Florida - Archer /ID# 150033

Gainesville, Florida, 32610, United States

Location

The Ctr for Gastro Disorders /ID# 150012

Hollywood, Florida, 33021, United States

Location

Nature Coast Clinical Research - Inverness /ID# 149975

Inverness, Florida, 34452-4717, United States

Location

Gastroenterology Associates of Central Georgia, LLC /ID# 149870

Macon, Georgia, 31201, United States

Location

GI Specialists of GA, PC /ID# 150015

Marietta, Georgia, 30060, United States

Location

Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900

Topeka, Kansas, 66606, United States

Location

Duplicate_University of Louisville /ID# 149884

Louisville, Kentucky, 40202, United States

Location

Investigative Clinical Research /ID# 149886

Annapolis, Maryland, 21401, United States

Location

Charm City Research Group /ID# 150040

Towson, Maryland, 21204, United States

Location

Clin Res Inst of Michigan, LLC /ID# 150008

Chesterfield, Michigan, 48047, United States

Location

Mayo Clinic - Rochester /ID# 149894

Rochester, Minnesota, 55905-0001, United States

Location

Kansas City Research Institute /ID# 149888

Kansas City, Missouri, 64131, United States

Location

Washington University-School of Medicine /ID# 149899

St Louis, Missouri, 63110, United States

Location

NYU Langone Long Island Clinical Research Associates /ID# 149976

Lake Success, New York, 11042, United States

Location

Weill Cornell Medicine/NYP /ID# 149895

New York, New York, 10021-4872, United States

Location

Univ NC Chapel Hill /ID# 149982

Chapel Hill, North Carolina, 27514-4220, United States

Location

University Of Cincinnati Medical Center /ID# 149977

Cincinnati, Ohio, 45219, United States

Location

Options Health Research, LLC /ID# 150010

Tulsa, Oklahoma, 74104, United States

Location

Texas Digestive Disease Consultants - Southlake /ID# 149869

Southlake, Texas, 76092, United States

Location

Texas Digestive Disease Consultants - Southlake /ID# 149989

Southlake, Texas, 76092, United States

Location

Aspen Clinical Research /ID# 150020

Orem, Utah, 84058, United States

Location

University of Virginia /ID# 149881

Charlottesville, Virginia, 22908, United States

Location

Virginia Mason Hospital & Medical Center /ID# 150042

Seattle, Washington, 98101, United States

Location

University of Washington /ID# 149988

Seattle, Washington, 98109, United States

Location

Wisconsin Center for Advanced Research /ID# 149863

Milwaukee, Wisconsin, 53215, United States

Location

Duplicate_CHU de Liege /ID# 149912

Liège, 4000, Belgium

Location

University of Alberta Hospital /ID# 149873

Edmonton, Alberta, T6G 2B7, Canada

Location

University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Duplicate_(G.I.R.I.) GI Research Institute Foundation /ID# 149878

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Toronto Digestive Disease Associates /ID# 149877

Vaughan, Ontario, L4L 4Y7, Canada

Location

Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 149871

Montreal, Quebec, H4A 3J1, Canada

Location

Hepato-Gastroenterologie HK, s.r.o. /ID# 149882

Hradec Králové, 500 12, Czechia

Location

Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890

Hvidovre, Capital Region, 2650, Denmark

Location

Duplicate_Aarhus University Hospital /ID# 149919

Aarhus N, Central Jutland, 8200, Denmark

Location

CHRU Nancy - Hopitaux de Brabois /ID# 149896

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

CHRU Lille - Hopital Claude Huriez /ID# 149897

Lille, Nord, 59037, France

Location

CHU Amiens-Picardie Site Sud /ID# 149921

Amiens, Somme, 80054, France

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936

Kiel, Schleswig-Holstein, 24105, Germany

Location

DRK Kliniken Berlin Westend /ID# 149905

Berlin, 14050, Germany

Location

Medizinisches Versorgungszentrum Portal 10 /ID# 149930

Münster, 48155, Germany

Location

Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907

Budapest, 1124, Hungary

Location

Yitzhak Shamir Medical Center /ID# 149943

Ẕerifin, Central District, 70300, Israel

Location

The Chaim Sheba Medical Center /ID# 149945

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Rabin Medical Center /ID# 149942

Petah Tikva, 4941492, Israel

Location

University of Catanzaro /ID# 149927

Catanzaro, Calabria, 88100, Italy

Location

Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 149958

Bologna, Emilia-Romagna, 40138, Italy

Location

Amsterdam UMC, locatie AMC /ID# 149932

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Universitair Medisch Centrum Utrecht /ID# 149933

Utrecht, 3584 CX, Netherlands

Location

Dunedin Hospital /ID# 149964

Otago, Otago, 9016, New Zealand

Location

Lovisenberg Diakonale Sykehus /ID# 149967

Oslo, 0440, Norway

Location

Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 149978

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979

Lodz, Łódź Voivodeship, 90-302, Poland

Location

Cabinet Particular Policlinic Algomed /ID# 149993

Timișoara, 300002, Romania

Location

Duplicate_KM Management, spol. s.r.o. /ID# 149949

Nitra, Nitra Region, 949 01, Slovakia

Location

Gastro I., s.r.o. /ID# 149948

Prešov, Presov, 080 01, Slovakia

Location

Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996

Ferrol, A Coruna, 15405, Spain

Location

Hospital Universitario La Paz /ID# 149997

Madrid, 28046, Spain

Location

Oxford University Hospitals NHS Foundation Trust /ID# 149963

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Duplicate_Manchester University NHS Foundation Trust /ID# 150006

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34968730 DERIVED

Related Links

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

MeSH Terms

Conditions

Crohn Disease

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 25, 2016
• Study Start: May 18, 2016
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

NO (1); IL (3); DK (2); NZ (1); HU (1); GB (2); CA (5); US (27); BE (1); FR (3); IT (2); SL (2); DE (3); PL (2); ES (2); CZ (1); RO (1); NL (2)