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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02365649




Registration number
NCT02365649
Ethics application status
Date submitted
16/02/2015
Date registered
19/02/2015
Date last updated
6/11/2017

Titles & IDs
Public title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Secondary ID [1] 0 0
2014-003240-12
Secondary ID [2] 0 0
M13-740
Universal Trial Number (UTN)
Trial acronym
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 - ABT-494
Treatment: Drugs - Placebo

Active Comparator: Induction Period ABT-494 Low Dose - Induction Period ABT-494 Low Dose orally dosed twice a day

Active Comparator: Induction Period ABT-494 Low/Medium Dose - Induction Period ABT-494 Low/Medium Dose orally dosed twice a day

Active Comparator: Induction Period ABT-494 Twice Daily Medium/High Dose - Induction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day

Active Comparator: Induction Period ABT-494 High Dose - Induction Period ABT-494 High Dose orally dosed twice a day

Active Comparator: Induction Period ABT-494 Once Daily Medium/High Dose - Induction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day

Placebo Comparator: Induction Period Placebo - Induction Period Placebo orally dosed twice a day

Active Comparator: Extension Phase ABT-494 Low Dose - Extension Phase ABT-494 Low Dose orally dosed twice a day

Active Comparator: Extension Phase ABT-494 Medium Dose - Extension Phase ABT-494 Medium Dose orally dosed twice a day

Active Comparator: Extension Phase ABT-494 High Dose - Extension Phase ABT-494 High Dose orally dosed twice a day


Treatment: Drugs: ABT-494
Oral Dosing

Treatment: Drugs: Placebo
Oral Dosing

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects who achieve endoscopic remission - Endoscopic remission will be determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD).
Timepoint [1] 0 0
Up to Week 16
Primary outcome [2] 0 0
Proportion of subjects who achieve clinical remission - Clinical remission to be determined at Week16
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
Proportion of subjects who achieve Crohn's Disease Activity Index (CDAI) less than 150 - Outcome to be measured by using CDAI
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Proportion of subjects with decrease in CDAI greater than or equal to 70 points - Outcome to be measured by using CDAI
Timepoint [2] 0 0
Up to Week 16
Secondary outcome [3] 0 0
Proportion of subjects who achieve remission at Week 52 - Remission to be determined at Week 52
Timepoint [3] 0 0
Week 52

Eligibility
Key inclusion criteria
1. Diagnosis of Crohn's disease (CD) for at least 90 days.

2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
equal to 450.

3. Subject inadequately responded to or experience intolerance to previous treatment with
immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or
anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.

2. Subject who has had surgical bowel resections in the past 6 months or is planning
resection.

3. Subjects with an ostomy or ileoanal pouch.

4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

5. Subject who has short bowel syndrome.

6. Subject with recurring infections or active Tuberculosis (TB).

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 2
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
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 hospital [1] 0 0
Concord Repatriation and General Hospital /ID# 133172 - Concord
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital /ID# 138163 - Herston
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
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United States of America
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California
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Colorado
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Florida
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Michigan
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Minnesota
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Mississippi
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Missouri
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North Carolina
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Oklahoma
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Tennessee
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Liege
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Roeselare
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Canada
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Edmonton
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London
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Montreal
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Sudbury
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Hradec Kralove
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Ramat Gan
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Israel
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Zerifin, Be'er Ya'akov
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Bologna
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Lodz
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Oxford
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United Kingdom
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Southampton, Hampshire

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

Ethics approval
Ethics application status

Summary
Brief summary
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately
to severely active Crohn's Disease with a history of inadequate response to or intolerance to
Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
Trial website
https://clinicaltrials.gov/show/NCT02365649
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ana Lacerda, MD
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