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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• Main ID: NCT03650413
• Date of registration: 16/08/2018
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: January 14, 2019
• Target sample size: 143
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03650413
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Bulgaria, China, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Moldova, Republic of, Netherlands, Poland, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

Inclusion Criteria for Study Entry:

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

Inclusion Criteria for Study Entry and Study Re-Entry:

- 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:

Exclusion Criteria for Study Entry:

- 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

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

Exclusion Criteria for Study Entry and Study Re-Entry:

- 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 values, as defined in the protocol, recorded at the last visit in
the parent study

Exclusion Criterion for Study Re-Entry:

- Use of prohibited concomitant therapy since enrolling in the extension study



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Ulcerative Colitis

Intervention(s)

Drug: UTTR1147A

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: Up to 2 years]

Secondary ID(s)

2017-004997-32

GA40209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/09/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03650413