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)

Use our guide to learn which trials are right for you!

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
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Chesterfield, Michigan 48098
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Hialeah, Florida 33010
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77084
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
310 Sterling Drive
Orchard Park, New York 14127
?
mi
from
Orchard Park, NY
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
23A bulevard "Nikola Vaptsarov"
Plovdiv, 4004
?
mi
from
Plovdiv,
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Pablo, California 94806
?
mi
from
San Pablo, CA
Click here to add this to my saved trials
?
mi
from
Syracuse, NY
Click here to add this to my saved trials