drugset / Trial / NCT03650413

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 ↗

Phase 2 Terminated 143 enrolled Genentech, Inc.
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2019-01-14
Primary completion
2022-07-12
Completion
2022-07-12

Outcome

Outcome not reported

Stopped: “This study was terminated early by the Sponsor based on the interim analysis of Study GA39925 (NCT03558152) that showed low efficacy of UTTR1147A in ulcerative colitis. Development of the drug in this indication has been terminated.”

Drugs

EvaluationDrugModalityDoseRoute
Subject UTTR1147A Protein / enzyme biologic — —