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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

NCT03650413 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2023-09-29

Study results available
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Summary

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 parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study GA39925 (NCT03558152).

Conditions

Interventions

DRUG

UTTR1147A

UTTR1147A will be administered based on disease status, as described in the protocol.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2022-07-12
Completion
2022-07-12
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Georgia
  • Germany
  • Greece
  • Ireland
  • Italy
  • Moldova
  • Poland
  • Russia
  • Serbia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03650413 on ClinicalTrials.gov