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An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599622
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Granulomatous Colitis Crohn's Disease Crohn's Enteritis Granulomatous Enteritis Drug: BMS-986165 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : December 26, 2022
Estimated Study Completion Date : December 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1 Drug: BMS-986165
oral administration

Experimental: BMS-986165 Dose 2 Drug: BMS-986165
oral administration

Placebo Comparator: Placebo Other: Placebo
oral administration




Primary Outcome Measures :
  1. Proportion of subjects achieving clinical remission [ Time Frame: 12 weeks ]
    Clinical remission defined by Crohn's Disease Activity Index (CDAI)

  2. Proportion of subjects achieving endoscopic response [ Time Frame: 12 weeks ]
    Endoscopic response defined by Simple Endoscopic Score for Crohn's Disease (SES-CD)


Secondary Outcome Measures :
  1. Proportion of participants who achieve endoscopic remission [ Time Frame: 12 weeks ]
  2. Proportion of participants who achieve a clinical response [ Time Frame: 12 weeks ]
  3. Proportion of Participants maintaining deep remission [ Time Frame: 12 weeks ]
  4. Proportion of participants who achieve PRO2 remission [ Time Frame: 12 weeks ]
  5. Changes from baseline in SES-CD [ Time Frame: 12 Weeks ]
  6. Proportion of participants achieving endoscopic normalization [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

Documented diagnosis of Crohn's Disease for at least 3 months

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599622


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 260 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03599622     History of Changes
Other Study ID Numbers: IM011-023
2017-001976-48 ( EudraCT Number )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Enteritis
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases