Lattice Study for Ulcerative Colitis (LATTICE-UC): A Phase 2 Randomized, Double-Blind, Placebo- Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis
The purpose of the LATTICE-UC is to evaluate how well the oral investigational drug (called BMS- 986165) works and how safe it is for patients with moderately to severely active ulcerative colitis.
Key Inclusion Criteria*:
Women or men may be able to take part in the LATTICE-UC study if you;
- Are 18 to 80 years old
- Have been diagnosed with UC for at least 12 weeks
- Currently have symptoms associated with moderately to severely active UC (adapted Mayo score of 5 to 9 points, endoscopic subscore of >= 2)
- Have not improved, or have not been able to tolerate, at least 1 prior UC medication. Eligible medications include 5-ASAs (such as sulfasalazine or mesalamine), corticosteroids, immunomodulators and biologic drugs (such as infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab).
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 Crohn's disease, indeterminate colitis, or ischemic colitis.
- Currently have fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
- History of colonic resection
*Other inclusion and exclusion criteria apply
- The LATTICE-UC 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 UC.
- Participants will have a 2 out of 3 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 the 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 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-UC 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 ulcerative colitis.
- This study will evaluate if BMS-986165 is safe and effective in the treatment of ulcerative colitis.
- 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 Ulcerative Colitis, 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.