Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 80 Years|
Inclusion Criteria:- Diagnosis of UC - Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score - Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment - Use of highly effective contraception as defined by the protocol
Exclusion Criteria:- History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis - History of cancer as defined by the protocol - Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal 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 or toxic megacolon within 12 months prior to screening - Suspicion of ischemic colitis, radiation colitis, or microscopic colitis - Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon - History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia - Prior treatment with UTTR1147A - Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents - Prior treatment with rituximab - Use of prohibited therapies, as defined by the protocol, prior to randomization - Congenital or acquired immune deficiency - Evidence or treatment of infections or history of infections, as defined by the protocol
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Hoffmann-La Roche|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Bulgaria, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Moldova, Republic of, Netherlands, Poland, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Experimental: Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Experimental: Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Experimental: Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Experimental: Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Experimental: Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Active Comparator: Arm 4: Vedolizumab
Parts A and B: Vedolizumab and UTTR1147A Placebo.
Placebo Comparator: Arm 5: Placebo
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
Drug: - UTTR1147A
UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.
Drug: - UTTR1147A Placebo
The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.
Drug: - Vedolizumab
Vedolizumab will be administered IV, as specified in the prescribing information.
Drug: - Vedolizumab Placebo
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.