Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

Phase 1

• Conditions: lcerative Colitis (UC) or Crohn's Disease (CD); MedDRA version: 20.0Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 100000004856; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; MedDRA version: 20.1Level: LLTClassification code 10033007Term: Other ulcerative colitisSystem Organ Class: 100000004856; MedDRA version: 20.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 100000004856; MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856; MedDRA version: 20.0Level: LLTClassification code 10075635Term: Acute hemorrhagic ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-004997-32-IT
• Lead Sponsor: GENENTECH, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-18
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 320

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 272
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

•Withdrawal of consent from parent study
•Discontinuation of study drug as required by the parent study protocol
•Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 or from Study GA39925 prior to Week 8
•Non compliance 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 18 weeks after final dose of study drug from Study GA39925 (due to the possibility of receiving vedolizumab), whichever is longer
•Any new malignancy since enrolling in the parent study
•Any new significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders, since enrolling in the parent study
•Any new signs or symptoms of infection judged by the investigator to be clinically significant since enrolling in the parent study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of UTTR1147A;Secondary Objective: - Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry criteria<br>- Ability to comply with requirements of the study, in the investigator's judgment<br>- Age 18-80 years<br>- For women and men: Use of highly effective contraception as defined by the protocol;Primary end point(s): 1. Occurrence and severity of adverse events, with severity determined<br>according to National Cancer Institute Common Terminology Criteria for<br>Adverse Events scale<br>2. Change in targeted vital signs, physical findings, and clinical<br>laboratory test results during and following UTTR1147A administration;Timepoint(s) of evaluation of this end point: 1-2. Up to 1 year