chronic inflammationof the mucosa of the colon and rectum Ulcerative Colitis
Conditions
Interventions
Sponsors
Shire
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study. 1. Subjects and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions. 2. Subjects must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study. 3. Subjects must be between *16 and *80 years of age at the time of the signing of the informed consent/assent form. NOTE: Subjects
Exclusion criteria
Exclusion criteria: Subjects are excluded from the study if any of the following exclusion criteria are met: 1. Subjects with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn*s disease. 2. Subjects with colonic dysplasia or neoplasia. (Subjects with prior history of adenomatous polyps will be eligible if the polyps have been completely removed.) 3. Subjects with past medical history or presence of toxic megacolon. 4. Subjects with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period. 5. Subjects at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit (Visit 2), unless the subject has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report (if biopsies are obtained) from the colonoscopy performed during screening or in the prior year confirming no evidance of dysplasia and colon colon must be available in the source documents. Subjects at risk for colorectal cancer include, but are not limited to: * Subjects with extensive colitis for *8 years or disease limited to left side of colon (ie, distal to splenic flexure) for *10 years before screening, regardless of age. * Subjects *50 years of age at the time of signing of the informed consent form. 6. Subjects have had prior treatment with ontamalimab (formerly PF-00547659; SHP647). 7. Subjects with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients. 8. Subjects have received anti-TNF treatment within 60 days before baseline (Visit 2). 9. Subjects have received any biologic with immunomodulatory properties (other than anti TNFs) within 90 days before baseline (Visit 2). 10. Subjects have received any nonbiologic treatment with immunomodulatory properties (other than their current background UC treatment) within 30 days before baseline (Visit 2). 11. Subjects have ever received anti-integrin/adhesion molecule treatment (eg, natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule). 12. Subjects have received parenteral or rectal glucocorticoids, or rectal 5-ASA, within 14 days before screening endoscopic procedure. 13. Subjects have received leukocyte apheresis or selective lymphocyte, monocyte, or granulocyte apheresis or plasma exchange within 30 days before baseline (Visit 2). 14. Subjects have participated in other investigational studies within either 30 days or 5 half lives of investigational product used in the study (whichever is longer) before baseline (Visit 2). 15. Subjects have received a live (attenuated) vaccine within 30 days before the baseline visit (Visit 2). 16. Subjects with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis [subjects with C. difficile infection at scree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of ontamalimab in inducing remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary: * To evaluate the efficacy of ontamalimab in achieving endoscopic remission, based on centrally read endoscopy. * To evaluate the efficacy of ontamalimab in achieving clinical remission, based on composite score of patient reported symptoms. * To evaluate the efficacy of ontamalimab in inducing clinical response, based on composite score of patient reported symptoms and centrally read endoscopy. * To evaluate the efficacy of ontamalimab in achieving mucosal healing, based on endoscopic and histological assessment using the Geboes Score grading system. Other Secondary: * To evaluate the safety and tolerability of ontamalimab. * To evaluate the effect of ontamalimab induction treatment on other clinical and endoscopic outcomes (including Mayo-based remission and clinical response, partial Mayo score over time, clinical remission over time, endoscopic remission, and deep remission). * To evaluate the effect of ontamalimab on abdominal pain, urgency, diarrhea, and absolute stool frequency and bleeding scores. * To evaluate the effect of ontamalimab on health related quality of life (as measured by the Inflammatory Bowel Disease Questionnaire [IBDQ] and the Short Form-36 Health Survey [SF-36]). * To evaluate the effect of ontamalimab on incidence of hospitalizations and total inpatient days. | — |
Countries
Netherlands
Outcome results
None listed