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

Crohn's Disease (CD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02782663
• Other study ID #: M14-327
• Secondary ID: 2015-003759-23
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 18, 2016
• Est. completion date: September 17, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: September 17, 2025
• Est. primary completion date: September 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease (CD)

Intervention

Drug:
• ABT-494
Tablet: Oral

Locations

Country	Name	City	State
Belgium	CHU de Liege /ID# 149912	Liege
Canada	University of Alberta Hospital /ID# 149873	Edmonton	Alberta
Canada	Royal Victoria Hospital / McGill University Health Centre /ID# 149871	Montreal	Quebec
Canada	GIRI Gastrointestinal Research Institute /ID# 149878	Vancouver	British Columbia
Canada	University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates, Inc. /ID# 149877	Vaughan	Ontario
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 149882	Hradec Kralove
Denmark	Duplicate_Aarhus University Hospital /ID# 149919	Aarhus N	Midtjylland
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890	Hvidovre	Hovedstaden
France	CHU Amiens-Picardie Site Sud /ID# 149921	Amiens CEDEX 1	Somme
France	CHRU Lille - Hopital Claude Huriez /ID# 149897	Lille	Nord
France	CHRU Nancy - Hopitaux de Brabois /ID# 149896	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
Germany	DRK Kliniken Berlin Westend /ID# 149905	Berlin
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936	Kiel	Schleswig-Holstein
Germany	Medizinisches Versorgungszentrum Portal 10 /ID# 149930	Muenster
Hungary	Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907	Budapest
Israel	Rabin Medical Center /ID# 149942	Haifa
Israel	The Chaim Sheba Medical Center /ID# 149945	Ramat Gan	Tel-Aviv
Israel	Yitzhak Shamir Medical Center /ID# 149943	Zerifin	HaMerkaz
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 149958	Bologna
Italy	University of Catanzaro /ID# 149927	Catanzaro	Calabria
Netherlands	Amsterdam UMC, locatie AMC /ID# 149932	Amsterdam	Noord-Holland
Netherlands	Universitair Medisch Centrum Utrecht /ID# 149933	Utrecht
New Zealand	Dunedin Hospital /ID# 149964	Otago
Norway	Lovisenberg Diakonale Sykehus /ID# 149967	Oslo
Poland	Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979	Lodz	Lodzkie
Poland	Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 149978	Warszawa	Mazowieckie
Romania	Cabinet Particular Policlinic Algomed /ID# 149993	Timi?oara
Slovakia	Duplicate_KM Management, spol. s.r.o. /ID# 149949	Nitra	Nitriansky Kraj
Slovakia	Gastro I., s.r.o. /ID# 149948	Prešov	Presovsky Kraj
Spain	Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996	Ferrol	A Coruna
Spain	Hospital Universitario La Paz /ID# 149997	Madrid
United Kingdom	Duplicate_Manchester University NHS Foundation Trust /ID# 150006	Manchester
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 149963	Oxford	Oxfordshire
United States	Investigative Clinical Research /ID# 149886	Annapolis	Maryland
United States	Univ NC Chapel Hill /ID# 149982	Chapel Hill	North Carolina
United States	University of Virginia /ID# 149881	Charlottesville	Virginia
United States	Clin Res Inst of Michigan, LLC /ID# 150008	Chesterfield	Michigan
United States	University of Cincinnati /ID# 149977	Cincinnati	Ohio
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	Kansas City Research Institute /ID# 149888	Kansas City	Missouri
United States	UC San Diego Health System /ID# 150041	La Jolla	California
United States	NYU Langone Long Island Clinical Research Associates /ID# 149976	Lake Success	New York
United States	Duplicate_University of Louisville /ID# 149884	Louisville	Kentucky
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	Wisconsin Center for Advanced Research /ID# 149863	Milwaukee	Wisconsin
United States	Weill Cornell Medicine/NYP /ID# 149895	New York	New York
United States	Aspen Clinical Research /ID# 150020	Orem	Utah
United States	Mayo Clinic - Rochester /ID# 149894	Rochester	Minnesota
United States	Washington University-School of Medicine /ID# 149899	Saint Louis	Missouri
United States	Univ California, San Francisco /ID# 149987	San Francisco	California
United States	University of Washington /ID# 149988	Seattle	Washington
United States	Virginia Mason Hospital & Medical Center /ID# 150042	Seattle	Washington
United States	Texas Digestive Disease Consultants - Southlake /ID# 149869	Southlake	Texas
United States	Texas Digestive Disease Consultants - Southlake /ID# 149989	Southlake	Texas
United States	Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900	Topeka	Kansas
United States	Charm City Research Group /ID# 150040	Towson	Maryland
United States	Options Health Research, LLC /ID# 150010	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  New Zealand,  Norway,  Poland,  Romania,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Remission	It is defined as the percentage of participants achieving clinical remission and endoscopic remission.	Up to Month 96
Primary	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
Primary	Percentage of Participants Achieving Response	It is defined as the percentage of participants achieving clinical response and endoscopic response.	Up to Month 96
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.	Up to Month 96
Primary	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
Primary	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
Primary	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
Primary	Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission	It is defined as CDAI less than 150.	Up to Month 96
Primary	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
Primary	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
Primary	Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission	IBDQ remission is defined as IBDQ >= 170.	Up to Month 96
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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