Ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis Syst
Conditions
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18-80 years - Diagnosis of UC - Moderate to severely active UC, defined by the Mayo Clinic Score - Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment and and/or corticosteroid treatment - Use of highly effective contraception as defined by the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year and primary sclerosing cholangitis - History of cancer as defined by the protocol - Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders (excluding UC) - Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC - Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis and toxic megacolon within 12 months prior to screening - Suspicion of ischemic colitis, radiation colitis, or microscopic colitis - Current fistula or history of fistula, current pericolonic abscess and Stricture (stenosis) of the colon - History or current evidence of unresectable colonic mucosal dysplasia and high-grade colonic mucosal dysplasia - Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents and rituximab - Use of prohibited therapies as defined by the protocol prior to randomization - Evidence or treatment of infections or history of infections as defined by the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of UTTR1147A compared with placebo and compared with vedolizumab based on clinical remission;Secondary Objective: • To evaluate the efficacy of UTTR1147A compared with placebo and compared with vedolizumab based on sustained remission, clinical response, endoscopic healing, endoscopic remission, UC bowel movement/abdominal signs and symptoms, and patient-reported health-related quality of life (QOL) • To evaluate the safety of UTTR1147A compared with placebo and compared with vedolizumab • To characterize the pharmacokinetics of UTTR1147A in patients with UC • To evaluate the immune response to UTTR1147A ;Primary end point(s): 1. Clinical remission;Timepoint(s) of evaluation of this end point: 1. At Week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Sustained remission 2. Clinical response 3. Endoscopic healing 4. Endoscopic remission 5. Change from baseline in ulcerative colitis bowel movement signs and symptoms, as assessed by Ulcerative Colitis-Patient-Reported Outcome Signs and Symptoms score (UC PRO/SS) 6. Change from baseline in UC abdominal signs and symptoms, as assessed by UC PRO/SS score 7. Change from baseline in patient-reported health related QOL, as assessed by Inflammatory Bowel Disease Questionnaire score 8. Occurrence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events scale 9. Change in targeted vital signs, physical findings, and clinical laboratory test results during and following study drug administration 10. Serum concentration of UTTR1147A at specified time points 11. Presence of anti-drug antibody (ADA) during the study relative to the presence of ADAs at baseline ;Timepoint(s) of evaluation of this end point: 1-4: At Weeks 10 and 30 5-7: Baseline to Weeks 10 and 30 8-9: Up to 45 months 10: At Weeks 0, 1, 2, 4, 6, 8, 10, 14, 30 and at safety follow-up visit (4 weeks after the last dose of study drug) and at unscheduled visit or disease evaluation or early termination 11: At Weeks 0, 6, 10, 22, 30 and at safety follow-up visit (8 weeks after the last dose of study drug) and at unscheduled visit or disease evaluation or early termination | — |
Countries
Bulgaria, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed