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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
26/07/2018
Date last updated
11/06/2020

Titles & IDs
Public title
An Investigational Study of Experimental Medication BMS-986165 in Participants 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 -

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 participants who achieve endoscopic remission
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Proportion of participants who achieve a clinical response
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Proportion of Participants maintaining deep remission
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Proportion of participants who achieve PRO2 remission
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Changes from baseline in SES-CD
Timepoint [5] 0 0
12 Weeks
Secondary outcome [6] 0 0
Proportion of participants achieving endoscopic normalization
Timepoint [6] 0 0
12 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
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
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Monash Medical Centre - Clayton
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4029 - Herston
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4101 - South Brisbane
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- Clayton
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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-CD, of the experimental medication
BMS-986165 in participants 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