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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02782663




Registration number
NCT02782663
Ethics application status
Date submitted
23/05/2016
Date registered
25/05/2016
Date last updated
6/05/2023

Titles & IDs
Public title
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
2015-003759-23
Secondary ID [2] 0 0
M14-327
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease (CD) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-494

Experimental: Upadacitinib (ABT-494) Dose A - Open label dose A once daily (QD)

Experimental: Upadacitinib (ABT-494) Dose B - Open label dose B QD


Treatment: Drugs: ABT-494
Tablet: Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Remission
Timepoint [1] 0 0
Up to Month 96
Primary outcome [2] 0 0
Percentage of Participants in Remission at Week 0 Who Maintain Remission
Timepoint [2] 0 0
Up to Month 96
Primary outcome [3] 0 0
Percentage of Participants Achieving Response
Timepoint [3] 0 0
Up to Month 96
Primary outcome [4] 0 0
Percentage of Participants Achieving Clinical Remission
Timepoint [4] 0 0
Up to Month 96
Primary outcome [5] 0 0
Percentage of Participants Achieving Modified Clinical Remission
Timepoint [5] 0 0
Up to Month 96
Primary outcome [6] 0 0
Percentage of Participants Achieving Enhanced Clinical Response
Timepoint [6] 0 0
Up to Month 96
Primary outcome [7] 0 0
Percentage of Participants Achieving Clinical Response
Timepoint [7] 0 0
Up to Month 96
Primary outcome [8] 0 0
Percentage of Participants Achieving Endoscopic Remission
Timepoint [8] 0 0
Up to Month 96
Primary outcome [9] 0 0
Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission
Timepoint [9] 0 0
Up to Month 96
Primary outcome [10] 0 0
Percentage of Participants Achieving Endoscopic Improvement
Timepoint [10] 0 0
Up to Month 96
Primary outcome [11] 0 0
Percentage of Participants Achieving Endoscopic Response
Timepoint [11] 0 0
Up to Month 96
Primary outcome [12] 0 0
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission
Timepoint [12] 0 0
Up to Month 96
Primary outcome [13] 0 0
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response
Timepoint [13] 0 0
Up to Month 96
Primary outcome [14] 0 0
Percentage of Participants Achieving Enhanced CDAI Response
Timepoint [14] 0 0
Up to Month 96
Primary outcome [15] 0 0
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission
Timepoint [15] 0 0
Up to Month 96
Primary outcome [16] 0 0
Percentage of Participants Achieving IBDQ Response
Timepoint [16] 0 0
Up to Month 96
Primary outcome [17] 0 0
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free
Timepoint [17] 0 0
Up to Month 96
Primary outcome [18] 0 0
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission
Timepoint [18] 0 0
Up to Month 96
Primary outcome [19] 0 0
Percentage of Participants Achieving Remission and Normal C-Reactive Protein
Timepoint [19] 0 0
Up to Month 96

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/09/2025
Actual
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Florida
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Georgia
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United States of America
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Kansas
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United States of America
State/province [5] 0 0
Kentucky
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United States of America
State/province [6] 0 0
Maryland
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United States of America
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Michigan
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Oklahoma
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United States of America
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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Belgium
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Liege
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Hradec Kralove
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Denmark
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Hovedstaden
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Denmark
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Midtjylland
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France
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Hauts-de-France
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France
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Meurthe-et-Moselle
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France
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Somme
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Muenster
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Hungary
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Budapest
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Israel
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Tel-Aviv
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Israel
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Be'Er Ya'Akov
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Israel
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Petakh Tikva
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Italy
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Calabria
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Italy
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Bologna
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Netherlands
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Amsterdam
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Netherlands
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Utrecht
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New Zealand
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Otago
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Norway
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Oslo
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Poland
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Lodzkie
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Poland
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Mazowieckie
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Romania
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Timi?oara
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Slovakia
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Nitra
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Slovakia
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Presov
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Spain
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A Coruna
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Spain
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Madrid
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United Kingdom
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Oxfordshire
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy,
safety, and tolerability of Upadacitinib (ABT-494).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02782663
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02782663