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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Ulcerative Colitis
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	UTTR1147A	UTTR1147A will be administered based on disease status, as described in the protocol.

Timeline

• Start date: 2019-01-14
• Primary completion: 2022-07-12
• Completion: 2022-07-12
• First posted: 2018-08-28
• Last updated: 2023-09-29
• Results posted: 2023-09-29

Locations

57 sites across 14 countries: United States, Bulgaria, Georgia, Germany, Greece, Ireland, Italy, Moldova, Poland, Russia, Serbia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study