Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Sponsors
Shire Human Genetic Therapies, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Subjects must be between =16 and =80 years of age at the time of the signing of the informed consent/assent form. NOTE: Subjects =65 years) yes F.1.3.1 Number of subjects for this age range 17
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 colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn’s disease. 2. Subjects with colonic dysplasia or neoplasia. 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 evidence of dysplasia and colon cancer 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 screening may be allowed re-test after treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the subj
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is 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).;Timepoint(s) of evaluation of this end point: Week 12 visit;Secondary Objective: • 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. ;Primary end point(s): The primary efficacy endpoint is remission at the Week 12 visit. Remission is defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as follows: • stool frequency subscore of 0 or 1 with at least a 1-point change from baseline AND • rectal bleeding subscore of 0 AND • endoscopic subscore of 0 or 1 (modified, excludes friability). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Endoscopic remission, as defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability), at the Week 12 visit. • Clinical remission, as defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0, at the Week 12 visit. • Clinical response based on composite score at the Week 12 visit. Clinical response (composite) is defined as a decrease from baseline in the composite score of patient-reported symptoms using daily-e diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding =1 point or a subscore for rectal bleeding =1. • Mucosal healing based on endoscopic and histological assessment at the Week 12 visit. Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of =2. ;Timepoint(s) of evaluation of this end point: Week 12 visit | — |
Countries
Australia, Austria, Brazil, Croatia, Czechia, Czech Republic, Germany, Greece, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, United Kingdom, United States
Contacts
Public ContactHolly Oakley
Shire Human Genetic Therapies, Inc.
Outcome results
None listed