Crohn's Disease Inflammatory Bowel Disease
Conditions
Interventions
Patients will be asked to delivering vagal nerve stimulator treatments using a
small magnet each day during the study. For other see page 17 'Schedule of
Assessments' of the study protocol and secti
Sponsors
SetPoint Medical Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Male or female subjects aged 18-75 years, inclusive -Written informed consent prior to any of the screening procedures -Diagnosis of Crohn's disease for more than 4 months prior to Week -4 Visit, with small bowel and/or colonic involvement -Current evidence of moderately-to-severely active disease defined by a Week -4 Visit Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive -Simple Endoscopic Score for Crohn*s Disease evaluation at baseline showing presence of a minimal ulcer score of 2 or 3 in at least 1 segment -Levels of fecal calprotectin greater than or equal to 200 microgram/gram feces at Week -4 Visit -History of inadequate response and/or intolerance or adverse events to one or more TNF-alpha inhibitors (e.g., infliximab, adalimumab, or certolizumab pegol) or vedolizumab. -Female subjects of child-bearing potential are eligible if not pregnant, not planning to become pregnant during the course of the study, and committed to use of contraceptive methods with a failure rate of less than 1 percent per year
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not to be enrolled in this study: -Celiac disease -Diagnosis of ulcerative or indeterminate colitis -Enterocutaneous, abdominal or pelvic fistulae with abscesses, or fistulae likely to require surgery during the course of the study period -Bowel surgery, other than appendectomy, within 12 weeks prior to Week -4 Visit and/or has planned surgery or deemed likely to need surgery for Crohn's disease during the study period -Extensive colonic resection, subtotal or total colectomy -Presence of ileostomies, colostomies or rectal pouches -Fixed symptomatic stenoses of small bowel or colon -History of more than 3 small bowel resections or diagnosis of short bowel syndrome -Use of prohibited medications inside the specified washout period (prior to Week -4 Visit), and throughout the study. Prohibited medications include the following: • TNF antagonists and vedolizumab may continue throughout the study, but treatments should have been given at a stable dose for at least 6 months prior to the screening date and should be maintained at this level throughout the study. • Use of natalizumab within 8 weeks • Use of glucocorticoids at doses greater than 10 mg prednisone orally QD, or an equivalent dose of other oral or parenteral glucocorticoids within 4 weeks • Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks • Use of intravenous antibiotics for Crohn's disease within 4 weeks • Use of parenteral, tube or enteral feeding, or elemental diet within 2 weeks • Rectal Treatment: Use of 5-aminosalicylates or corticosteroid enemas or suppositories within 2 weeks • Azathioprine, 6-mercaptopurine and methotrexate can be continued throughout the trial. These medications must have been used for >12 weeks, at stable dose for at least 3 weeks prior to the Week -4 Visit. -Leukocytopheresis or granulocytopheresis within 2 weeks prior to Week -4 Visit -Positive immunoassay for Clostridium difficile at Week -4 Visit -Known HIV infection -Known active in infection with HBV or HCV -Current evidence of, or has been treated for a malignancy within the past five years (other than localized basal cell or squamous cell skin cancer, cervical dysplasia, or any cancer which has been fully staged as in situ and has been fully resected) -History of evidence of adenomatous colonic polyps that have not been removed. -Use of any investigational product within 30 days prior to Week -4 Visit for small molecules, or 8 weeks prior for monoclonal antibodies -Significant psychiatric disease or substance abuse -History of unilateral or bilateral vagotomy -History of recurrent vaso-vagal syncope episodes -Known obstructive sleep apnea -Known history of cardiac rhythm disturbances, atrio-ventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block. Evaluation by a cardiologist is required if the family history, patient history, or electrocardiogram suggests an abnormal cardiac conduction pathway. -Significant pharyngeal dysfunction or swallowing difficulties -Pre-existing clinically significant vocal cord damage or hoarseness -Previously implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Change in CDAI from baseline to Week 16 Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: -Rate of clinical response at Week 16 Visit defined as CDAI improvement from baseline of at least 70 points -Rate of clinical remission at Week 16 Visit defined as CDAI less than or equal to 150 -Change in IBDQ total score and subscale scores from baseline to Week 16 Visit -Change in total SES-CD score from baseline to Week 16 Visit -Endoscopic Response Rate: Percentage of patients with drop in total SES-CD score of at least 50% from baseline to Week 16 Visit -Endoscopic Remission Rate: Percentage of patients with no ulcers larger than aphthous ulcers in any segment (i.e., all observed segments have an ulcer score of | — |
Countries
Netherlands
Outcome results
None listed