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) |
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.
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
We found this trial at
20
sites
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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
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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