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Lattice Study for Crohn’s Disease (LATTICE-CD): A Phase 2 Randomized, Double-Blind, Placebo- Controlled Study of the Safety and Efficacy of BMS 986165 in Participants with Moderate to Severe Crohn's Disease

Published: 10/28/2020

General Information:

Bristol-Myers Squibb
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Study Objective

The purpose of the LATTICE-CD is to evaluate how well an oral investigational drug (called BMS- 986165) works and how safe it is for patients with moderately to severely active Crohn’s disease.

Phase of study
Phase 2
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Eligibility:

Age
Adult (18+)
Gender
Female
Male
Disease Type
Crohn's Disease
Severity
Moderate
Severe
Eligibility Criteria

Key Inclusion Criteria*:
Women or men may be able to take part in the LATTICE-CD study if you;

  • Are 18 to 75 years of age
  • Have been diagnosed with Crohn's disease for at least 3 months
  • Currently have symptoms associated with moderately to severely active Crohn’s disease
  • Have not improved, or have not been able to tolerate, at least 1 prior Crohn’s disease medication. Eligible medications include 5-ASAs (such as sulfasalazine or mesalamine), corticosteroids, immunomodulators and biologic drugs (such as infliximab, adalimumab, certolizumab pegol, vedolizumab or natalizumab).

Key Exclusion Criteria*:
You may not be able to take part in this study if any of the following apply to you:

  • Diagnosis of another disease that can cause inflammation of the colon or intestine, such as ulcerative colitis, indeterminate colitis, radiation colitis or ischemic colitis
  • Currently have severe or fulminant colitis that is likely to require surgery or hospitalization

*Other inclusion and exclusion criteria apply

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Study Details:

Study Description:

  • The LATTICE-CD study is designed to evaluate the safety and effectiveness of BMS-986165, an oral investigational study drug, compared with placebo (an inactive substance) to see if it may reduce symptoms of moderate to severe CD.
  • Participants will have a 3 out of 4 chance of receiving the active investigational drug at the start of the study.
  • Treatment assignment is blinded, so that neither you nor your doctor will know if you are receiving active study drug or placebo.
  • Participants who do not have an adequate response at Week 12 may be eligible to receive open- label BMS-986165, where you will know that you are receiving the active investigational drug.
  • Participation in the blinded period of this study is expected to last up to 52 weeks (1 year).
  • Depending on your response and the study doctor’s recommendation, you may be eligible to receive active study drug for an additional 52 weeks (1 year) within this study.

Description of treatment or intervention (mechanism of action):

  • In the LATTICE-CD study, doctors want to evaluate the investigational drug BMS-986165.
  • They want to compare the investigational drug to placebo, which looks like the investigational drug, but contains no active medication.
  • The investigational drug is thought to act on the body’s immune system to inhibit inflammation pathways that are thought to be important in Crohn’s disease.
  • This study will evaluate if BMS-986165 is safe and effective in the treatment of Crohn’s disease.
  • The patient will receive either placebo or the investigational drug.

Patient Participation Requirements:

If qualified, patients will be asked to:

  • Attend all study visits (12 during the first 52 week treatment period).
  • Take the oral investigational drug as directed.
  • A variety of assessments such as lab tests, vital signs, physical exams, and endoscopies will be performed.
  • Complete all questionnaires at study visits and maintain a daily electronic diary (to be provided) at home reporting details of Crohn’s disease, study dosing frequency, and any symptoms or side effects experienced.

Possible risks and side effects:

  • BMS-986165 is still being studied, so not all of its potential side-effects are known.
  • The most common side-effects seen in a recent Phase 2 clinical trial of BMS-986165 in psoriasis, a skin disease, included nose and throat irritation, headache, diarrhea, nausea and upper respiratory tract infection.
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Contact Information:

Site Locations

University of Miami Miller School of Medicine 1120 Northwest 14th Street Room 969 Miami, Florida 33136
Raciel Del Rio
1 (305) 243-6405
[email protected]
Louisiana Research Center 1800 East 70th Street Shreveport, Louisiana 71105
Tricia Walker
1 (318) 525-3233
[email protected]
Texas Clinical Research Institute 1009 Magnolia Street Arlington, Texas 76012
Ian Mumm
1 (817) 471-1070
[email protected]
Florida Center for Gastroenterology 8250 Bryan Dairy Road Suite 200 Largo, Florida 33777
Joann Stell
1 (727) 544-1600 ext: 335
[email protected]
Southern Star Research Institute - Medical Center Office 2833 Babcock Road Suite 206 San Antonio, Texas 78229
Rebecca Delagarza
1 (210) 581-2794
[email protected]
Florida Medical Clinic - Clinical Research Division 38135 Market Square Zephyrhills, Florida 33542
William Johnston
1 (813) 780-8368 ext: 185
[email protected]
Penn State Health Milton S. Hershey Medical Center 200 Campus Drive Entrance 4 Suite 2400 Hershey, Pennsylvania 17033
Zvjezdana Chroneos
1 (717) 531-0003 ext: 322136
[email protected]
Gastroenterology Associates of Western Michigan 2093 Health Drive Suite 201 Wyoming, Michigan 49519
Kayla Hinson
1 (616) 328-5319
[email protected]
Tyler Research Institute 1720 South Beckham Avenue Tyler, Texas 75701
Deborah Nelson
1 (903) 630-6211
[email protected]
Clinical Research Institute of Michigan 30795 23 Mile Road Suite 206 Chesterfield, Michigan 48047
Aaron Ryder
1 (586) 598-3329
[email protected]
Advanced Research Institute - New Port Richey 7114 Congress Street New Port Richey, Florida 34653
Christina Velazquez
1 (727) 835-3261
[email protected]
New York Langone Long Island Clinical Research Associates 1999 Marcus Avenue Suite 300 Lake Success, New York 11042
Susan Eugene
1 (516) 466-1051 ext: x330
[email protected]
The Medical Research Center of Connecticut 2200 Whitney Avenue Suite 370 Hamden, Connecticut 06518
Jennifer Nikolich
1 (203) 281-5161
[email protected]
Advanced Biomedical Research of America 8420 South Eastern Avenue Suite 102 Las Vegas, Nevada 89123
Adrian Bratu
1 (702) 898-2088
[email protected]
Clinical Research of West Florida - Tampa 5115 North Armenia Avenue Tampa, Florida 33603
Justin Busby
1 (813) 870-1292
[email protected]
Digestive Health Center - Ocean Springs 3890 Bienville Boulevard Ocean Springs, Mississippi 39564
LuAn Brown
1 (228) 218-1672
[email protected]
Spring Gastroenterology Associates - Houston 6225 FM2920 Road Suite 203 Spring, Texas 77379
Merzieh Aijaz
1 (832) 653-9490
[email protected]
Florida Hospital Orlando 601 East Rollins Street Orlando, Florida 32803
Yvette Trahan
1 (407) 609-3947
[email protected]
Hunter Holmes McGuire Veterans Administration Medical Center 1201 Broad Rock Boulevard Gi Section (111-N) Richmond, Virginia 23249
Lisa Markwalter
1 (804) 675-6789
[email protected]
University of Iowa Hospitals and Clinics 200 Hawkins Drive Iowa City, Iowa 52242
Debi Heitshusen
1 (319) 353-4574
[email protected]
Digestive Health Associates of Texas - Richardson 7150 North President George Bush Highway Suite 201 Garland, Texas 75044
Arlen Waclawczyk
1 (972) 265-8201
[email protected]
Vanderbilt University Medical Center 1211 21st Avenue South Medical Arts Building Room 103C Nashville, Tennessee 37212
Mary Kay West
1 (615) 875-3399
[email protected]
University of Pittsburgh Medical Center G310 Presbyterian Hospital 200 Lothrop Street Pittsburgh, Pennsylvania 15260
Lori Snyder
1 (412) 647-8362
[email protected]
Huron Gastroenterology Associates 5300 Elliott Drive Ypsilanti, Michigan 48197
Ellen Dobrusin
1 (734) 714-0523
[email protected]
Clinical Trials of South Carolina 2695 Elms Plantation Boulevard Suite A & D Charleston, South Carolina 29406
Nathelia O'Banner
1 (843) 725-5067
[email protected]
Troy Gastroenterology 4550 Investment Drive Suite 260 Troy, Michigan 48098
Barbara Gosler
1 (248) 267-8485
[email protected]
Gastroenterology Consultants of Clearwater 508 Jeffords Street Suite D Clearwater, Florida 33756
Emilee Cabatana
1 (727) 336-5490
[email protected]
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