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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03345849




Registration number
NCT03345849
Ethics application status
Date submitted
15/11/2017
Date registered
17/11/2017

Titles & IDs
Public title
A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
Secondary ID [1] 0 0
2017-001240-35
Secondary ID [2] 0 0
M14-433
Universal Trial Number (UTN)
Trial acronym
U-EXCEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 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 - Upadacitinib
Treatment: Drugs - Placebo for Upadacitinib

Placebo comparator: Placebo - Participants will receive placebo once daily for 12 weeks in Part 1. Clinical non-responders will receive 45 mg upadacitinib once daily for 12 weeks in Part 2.

Experimental: Upadacitinib - Participants will receive 45 mg upadacitinib once daily for 12 weeks in Part 1. Clinical non-responders will receive 30 mg upadacitinib once daily for 12 weeks in Part 2.


Treatment: Drugs: Upadacitinib
Oral; Tablet

Treatment: Drugs: Placebo for Upadacitinib
Oral; Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Percentage of Participants With Endoscopic Response at Week 12
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Endoscopic Remission at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per CDAI at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2
Timepoint [5] 0 0
Baseline and Week 2
Secondary outcome [6] 0 0
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Percentage of Participants With Clinical Remission Per CDAI at Week 4
Timepoint [7] 0 0
Week 4
Secondary outcome [8] 0 0
Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During the 12-Week Induction Period
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Percentage of Participants With Resolution of Extra-Intestinal Manifestation (EIMs) at Week 12
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Percentage of Participants With Clinical Remission Per PROs at Week 4
Timepoint [10] 0 0
Week 4
Secondary outcome [11] 0 0
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per PROs at Week 12
Timepoint [11] 0 0
Week 12

Eligibility
Key inclusion criteria
* Confirmed diagnosis of CD for at least 3 months prior to Baseline.
* Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
* Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
* Demonstrated an inadequate response or intolerance to one or more conventional and/or biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids, immunosuppressants or biologic therapies for CD), in the opinion of the investigator.

* Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).
* If female, participant must meet the contraception recommendations.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
* Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, or any other manifestation that might require surgery while enrolled in the study.
* Participant with ostomy or ileoanal pouch.
* Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
* Screening laboratory and other analyses show abnormal results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/01/2022
Sample size
Target
Accrual to date
Final
526
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital /ID# 171512 - Concord
Recruitment hospital [2] 0 0
Coral Sea Clinical Research institute /ID# 212988 - North Mackay
Recruitment hospital [3] 0 0
Mater Misericordiae Limited /ID# 204909 - South Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital /ID# 171514 - Adelaide
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Box Hill Hospital /ID# 203736 - Box Hill
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 171513 - Murdoch
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2139 - Concord
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4740 - North Mackay
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4101 - South Brisbane
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5000 - Adelaide
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3128 - Box Hill
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6150 - Murdoch
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Slovakia
State/province [206] 0 0
Banska Bystrica
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Slovakia
State/province [207] 0 0
Nitra
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Slovenia
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Ljubljana
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Free State
Country [210] 0 0
South Africa
State/province [210] 0 0
Gauteng
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South Africa
State/province [211] 0 0
Western Cape
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Spain
State/province [212] 0 0
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State/province [213] 0 0
Navarra
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Spain
State/province [214] 0 0
A Coruna
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Spain
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Barcelona
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Spain
State/province [216] 0 0
Girona
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Spain
State/province [217] 0 0
Huelva
Country [218] 0 0
Spain
State/province [218] 0 0
Madrid
Country [219] 0 0
Spain
State/province [219] 0 0
Salamanca
Country [220] 0 0
Spain
State/province [220] 0 0
Sevilla
Country [221] 0 0
Spain
State/province [221] 0 0
Valencia
Country [222] 0 0
Sweden
State/province [222] 0 0
Hallands Lan
Country [223] 0 0
Sweden
State/province [223] 0 0
Stockholms Lan
Country [224] 0 0
Sweden
State/province [224] 0 0
Vastra Gotalands Lan
Country [225] 0 0
Switzerland
State/province [225] 0 0
Zuerich
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Switzerland
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Taichung City
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Taiwan
State/province [228] 0 0
Taichung
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Taiwan
State/province [229] 0 0
Taipei City
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Turkey
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Istanbul
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Turkey
State/province [231] 0 0
Kayseri
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Turkey
State/province [232] 0 0
Ankara
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Turkey
State/province [233] 0 0
Battalgazi/malatya
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Turkey
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Hatay
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Turkey
State/province [235] 0 0
Mersin
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Turkey
State/province [236] 0 0
Sisli
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Turkey
State/province [237] 0 0
Yenimahalle
Country [238] 0 0
Ukraine
State/province [238] 0 0
Kyivska Oblast
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Ukraine
State/province [239] 0 0
Kharkiv
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Ukraine
State/province [240] 0 0
Kyiv
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Ukraine
State/province [241] 0 0
Lviv
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Ukraine
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Vinnytsia
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United Kingdom
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Antrim
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United Kingdom
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United Kingdom
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Bath
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United Kingdom
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Birmingham
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Dudley
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United Kingdom
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London
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Stockport
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United Kingdom
State/province [251] 0 0
Taunton
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United Kingdom
State/province [252] 0 0
Tooting
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United Kingdom
State/province [253] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03345849