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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02782663
Ethics application status
Date submitted
23/05/2016
Date registered
25/05/2016
Date last updated
17/02/2020

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 - It is defined as the percentage of participants achieving clinical remission and endoscopic 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 - Remission is defined as participants achieving clinical remission and endoscopic remission.
Timepoint [2] 0 0
Up to Month 96
Primary outcome [3] 0 0
Percentage of Participants Achieving Response - It is defined as the percentage of participants achieving clinical response and endoscopic response.
Timepoint [3] 0 0
Up to Month 96
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to Month 96
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
Up to Month 96
Primary outcome [6] 0 0
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.
Timepoint [6] 0 0
Up to Month 96
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
Up to Month 96
Primary outcome [8] 0 0
Percentage of Participants Achieving Endoscopic Remission - Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
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 - Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
Timepoint [9] 0 0
Up to Month 96
Primary outcome [10] 0 0
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.
Timepoint [10] 0 0
Up to Month 96
Primary outcome [11] 0 0
Percentage of Participants Achieving Endoscopic Response - Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.
Timepoint [11] 0 0
Up to Month 96
Primary outcome [12] 0 0
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission - It is defined as CDAI less than 150.
Timepoint [12] 0 0
Up to Month 96
Primary outcome [13] 0 0
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.
Timepoint [13] 0 0
Up to Month 96
Primary outcome [14] 0 0
Percentage of Participants Achieving Enhanced CDAI Response - Enhanced CDAI response is defined as reduction in CDAI by >= 100 from baseline of Study M13-740.
Timepoint [14] 0 0
Up to Month 96
Primary outcome [15] 0 0
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission - IBDQ remission is defined as IBDQ >= 170.
Timepoint [15] 0 0
Up to Month 96
Primary outcome [16] 0 0
Percentage of Participants Achieving IBDQ Response - IBDQ response is defined as an increase in IBDQ score >= 16 point from Baseline of Study M13-740.
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 - 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 - 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
Timepoint [18] 0 0
Up to Month 96
Primary outcome [19] 0 0
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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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United States of America
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Georgia
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United States of America
State/province [4] 0 0
Kansas
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United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
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United States of America
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New York
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United States of America
State/province [11] 0 0
North Carolina
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United States of America
State/province [12] 0 0
Ohio
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United States of America
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Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Belgium
State/province [19] 0 0
Liege
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Denmark
State/province [25] 0 0
Midtjylland
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Denmark
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Hvidovre
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France
State/province [27] 0 0
Hauts-de-France
Country [28] 0 0
France
State/province [28] 0 0
Meurthe-et-Moselle
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France
State/province [29] 0 0
Somme
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Germany
State/province [30] 0 0
Schleswig-Holstein
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Germany
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Berlin
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Germany
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Munster
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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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Ramat Gan
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Italy
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Calabria
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Italy
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Emilia-Romagna
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Netherlands
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Noord-Holland
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Netherlands
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Utrecht
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New Zealand
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Dunedin
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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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Timisoara
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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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Ferrol
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Spain
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Madrid
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United Kingdom
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Manchester
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United Kingdom
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Oxford

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/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
Other publications