An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/31/2019
Start Date:January 14, 2019
End Date:December 17, 2022
Contact:Reference Study ID Number: GA40209 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 Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease

This study will evaluate the long-term safety and tolerability of UTTR1147A in participants
with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320
participants from the Phase Ib Study GA29469 and Phase II Study GA39925 (parent studies).


Inclusion Criteria:

- Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry
criteria

- Ability to comply with requirements of the study, in the investigator's judgment

- For women and men: use of highly effective contraception as defined by the protocol.

Exclusion Criteria:

- Withdrawal of consent from parent study

- Discontinuation of study drug as required by the parent study protocol

- Noncompliance in the parent study, specifically defined as missing scheduled visits or
non-adherence with background medications and concomitant medications

- Pregnant or breastfeeding, or intending to become pregnant during the study or within
8 weeks after the final dose of study drug or within 18 weeks after the final dose of
study drug from GA39925, whichever is longer

- Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary,
renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms of
infection judged by the investigator to be clinically significant since enrolling in
the parent study

- Use of prohibited therapies as defined in the parent study

- Abnormal laboratory value recorded at the last visit in the parent study
We found this trial at
21
sites
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Chesterfield, Michigan 48098
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Chevy Chase, Maryland 20815
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Germantown, Tennessee 38138
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Greenville, North Carolina 27834
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Hialeah, Florida 33010
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Houston, Texas 77084
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Naples, Florida 34102
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310 Sterling Drive
Orchard Park, New York 14127
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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23A bulevard "Nikola Vaptsarov"
Plovdiv, 4004
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San Pablo, California 94806
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