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

Phase 2

Withdrawn

Conditions: a type of Inflamatory bowel disease that may affect any part of the gastrointestinal tract from mouth to anus
chronic inflammation of the mucosa of the colon and rectum/ Crohn's Disease
Ulcerative Colitis
10017969

Registration Number: NL-OMON46443

Lead Sponsor: Genentech, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 2

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;- Age 18-80 years;- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety objective:<br /><br>* Occurrence and severity of adverse events, with severity determined according<br /><br>to NCI CTCAE scale<br /><br>* Change in targeted vital signs, physical findings, and clinical laboratory<br /><br>test results during and following UTTR1147A administration</p><br>

Secondary Outcome Measures