A 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: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856; MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856; MedDRA version: 20.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 100000004856; MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856; MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856; MedDRA version: 20.0 Level: LLT Classification code 10075635 Term: Acute hemorrhagic ulcerative colitis System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-004997-32-HU
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-04
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• 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
- 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 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: n.a.;Timepoint(s) of evaluation of this end point: 1-2. Up to 1 year;<br> Primary end point(s): 1. Occurrence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events scale<br> 2. Change in targeted vital signs, physical findings, and clinical laboratory test results during and following UTTR1147A administration<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a.