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:
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
Louisiana Research Center
1800 East 70th Street
Shreveport,
Louisiana 71105
Texas Clinical Research Institute
1009 Magnolia Street
Arlington,
Texas 76012
Florida Center for Gastroenterology
8250 Bryan Dairy Road
Suite 200
Largo,
Florida 33777
Southern Star Research Institute - Medical Center Office
2833 Babcock Road
Suite 206
San Antonio,
Texas 78229
Florida Medical Clinic - Clinical Research Division
38135 Market Square
Zephyrhills,
Florida 33542
Penn State Health Milton S. Hershey Medical Center
200 Campus Drive
Entrance 4 Suite 2400
Hershey,
Pennsylvania 17033
Gastroenterology Associates of Western Michigan
2093 Health Drive
Suite 201
Wyoming,
Michigan 49519
Tyler Research Institute
1720 South Beckham Avenue
Tyler,
Texas 75701
Clinical Research Institute of Michigan
30795 23 Mile Road
Suite 206
Chesterfield,
Michigan 48047
Advanced Research Institute - New Port Richey
7114 Congress Street
New Port Richey,
Florida 34653
New York Langone Long Island Clinical Research Associates
1999 Marcus Avenue
Suite 300
Lake Success,
New York 11042
The Medical Research Center of Connecticut
2200 Whitney Avenue
Suite 370
Hamden,
Connecticut 06518
Advanced Biomedical Research of America
8420 South Eastern Avenue
Suite 102
Las Vegas,
Nevada 89123
Clinical Research of West Florida - Tampa
5115 North Armenia Avenue
Tampa,
Florida 33603
Digestive Health Center - Ocean Springs
3890 Bienville Boulevard
Ocean Springs,
Mississippi 39564
Spring Gastroenterology Associates - Houston
6225 FM2920 Road
Suite 203
Spring,
Texas 77379
Florida Hospital Orlando
601 East Rollins Street
Orlando,
Florida 32803
Hunter Holmes McGuire Veterans Administration Medical Center
1201 Broad Rock Boulevard
Gi Section (111-N)
Richmond,
Virginia 23249
University of Iowa Hospitals and Clinics
200 Hawkins Drive
Iowa City,
Iowa 52242
Digestive Health Associates of Texas - Richardson
7150 North President George Bush Highway
Suite 201
Garland,
Texas 75044
Vanderbilt University Medical Center
1211 21st Avenue South
Medical Arts Building Room 103C
Nashville,
Tennessee 37212
University of Pittsburgh Medical Center
G310 Presbyterian Hospital
200 Lothrop Street
Pittsburgh,
Pennsylvania 15260
Huron Gastroenterology Associates
5300 Elliott Drive
Ypsilanti,
Michigan 48197
Clinical Trials of South Carolina
2695 Elms Plantation Boulevard
Suite A & D
Charleston,
South Carolina 29406
Troy Gastroenterology
4550 Investment Drive
Suite 260
Troy,
Michigan 48098
Gastroenterology Consultants of Clearwater
508 Jeffords Street
Suite D
Clearwater,
Florida 33756
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