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)



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:4/3/2019
Start Date:October 26, 2018
End Date:September 24, 2021
Contact:Reference Study ID: GA39925 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. Only)

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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

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A
compared with vedolizumab and with placebo in the treatment of participants with moderate to
severe UC. This study will consist of two parts, Part A and Part B. Part A will test the
induction of clinical remission and Part B will test the durability of clinical remission.


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
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23A bulevard "Nikola Vaptsarov"
Plovdiv, 4004
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Miami, Florida 33124
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University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
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30795 23 Mile Rd # 206
Chesterfield, Michigan 48047
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Germantown, Tennessee 38138
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Houston, Texas 77030
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310 Sterling Drive
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Syracuse, New York 13210
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