A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.
- Conditions
- lcerative colitis (UC)MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10033007Term: Other ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.0Level: LLTClassification code 10075635Term: Acute hemorrhagic ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-002350-36-DE
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
- 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 243
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>• To evaluate the safety of UTTR1147A compared with placebo and compared with vedolizumab<br>• To characterize the pharmacokinetics of UTTR1147A in patients with UC<br>• To evaluate the immune response to UTTR1147A<br>;Primary end point(s): 1. Clinical remission;Timepoint(s) of evaluation of this end point: 1. At Week 8
- Secondary Outcome Measures
Name Time Method