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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03599622




Registration number
NCT03599622
Ethics application status
Date submitted
11/07/2018
Date registered
25/07/2018
Date last updated
15/07/2019

Titles & IDs
Public title
An Investigational Study of Experimental Medication BMS-986165 in Patients With Moderate to Severe Crohn's Disease
Scientific title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease
Secondary ID [1] 0 0
2017-001976-48
Secondary ID [2] 0 0
IM011-023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Granulomatous Colitis 0 0
Crohn's Disease 0 0
Crohn's Enteritis 0 0
Granulomatous Enteritis 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
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Other interventions - Placebo

Experimental: BMS-986165 Dose 1 -

Experimental: BMS-986165 Dose 2 -

Experimental: BMS-986165 Dose 3 -

Placebo Comparator: Placebo -


Treatment: Drugs: BMS-986165
oral administration

Other interventions: Placebo
oral administration

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects achieving clinical remission - Clinical remission defined by Crohn's Disease Activity Index (CDAI)
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Proportion of subjects achieving endoscopic response - Endoscopic response defined by Simple Endoscopic Score for Crohn's Disease (SES-CD)
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Proportion of subjects who achieve endoscopic remission - Endoscopic remission defined by SES-CD
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Proportion of subjects who achieve a clinical response - Clinical response defined as a reduction from baseline in the CDAI score
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Proportion of subjects who achieve a clinical response - Clinical response defined as a reduction from baseline in the CDAI score
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Proportion of subjects achieving clinical remission - Clinical remission defined by abdominal pain and stool frequency
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
Proportion of subjects achieving endoscopic remission - Endoscopic remission defined by SES-CD
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
Proportion of subjects who achieve an endoscopic response - Endoscopic response defined by SES-CD scores
Timepoint [6] 0 0
52 weeks
Secondary outcome [7] 0 0
Proportion of subjects achieving complete mucosal healing - Complete mucosal healing defined by SES-CD
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Proportion of subjects achieving complete mucosal healing - Complete mucosal healing defined by SES-CD
Timepoint [8] 0 0
52 weeks
Secondary outcome [9] 0 0
Proportion of subjects achieving deep remission - Deep remission is defined as achieving both endoscopic remission defined by SES-CD and clinical remission defined by CDAI
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Proportion of subjects maintaining deep remission - Deep remission is defined as achieving both endoscopic remission defined by SES-CD and clinical remission defined by CDAI
Timepoint [10] 0 0
52 weeks

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- Documented diagnosis of Crohn's Disease for at least 3 months
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe or fulminant colitis that is likely to require surgery or hospitalization

- Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory
including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than
Crohn's Disease

Other protocol defined inclusion/exclusion criteria could apply

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
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Final
Recruitment in Australia
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QLD,VIC
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Local Institution - Herston
Recruitment hospital [2] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Local Institution - Fitzroy
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an investigational study, also known as LATTICE, of the experimental medication
BMS-986165 in patients with moderate to severe Crohn's Disease, a chronic bowel disease that
causes severe inflammation of the digestive tract.
Trial website
https://clinicaltrials.gov/show/NCT03599622
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03599622