TrialScout

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

All
Age
18 - 80
Phase 2

Brief Summary

A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter 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



ClinicalTrials.gov Identifier: NCT03558152
Recruitment Status: Recruiting
First Posted: 6/15/2018 12:00:00 AM
Last Update Posted: 8/12/2019 12:00:00 AM

Keywords

Colitis
Colitis, Ulcerative
Ulcer

Intervention/Treatment

Drug: Vedolizumab Placebo / The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

You may be eligible to join if...




- 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

You may NOT be eligible to join if...



- 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

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