Etrolizumab
Sponsors
Genentech, Inc., Hoffmann-La Roche
Conditions
Colitis, UlcerativeCrohn DiseaseCrohn's DiseaseCrohn's disease
inflammatory bowel diseaseHealthy VolunteerHealthy VolunteersUlcerative Colitischronic bowel inflamation
inflammatory bowel disease
Phase 1
A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants
CompletedNCT02629744
Start: 2015-12-31End: 2016-06-30Updated: 2016-11-02
A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)
CompletedNCT02996019
Start: 2016-12-07End: 2018-04-09Updated: 2018-12-03
A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease
TerminatedNCT03478956
Start: 2018-03-27End: 2023-09-27Updated: 2024-12-27
Phase 2
Phase 3
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
TerminatedNCT02118584
Start: 2014-09-15End: 2023-10-05Updated: 2024-10-23
A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors
CompletedNCT02136069
Start: 2014-12-24End: 2020-06-23Updated: 2021-12-03
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
CompletedNCT02163759
Start: 2014-11-04End: 2020-03-19Updated: 2021-07-23
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
CompletedNCT02165215
Start: 2014-08-12End: 2020-04-06Updated: 2021-08-19
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
CompletedNCT02171429
Start: 2014-11-14End: 2020-05-25Updated: 2021-07-23
A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
CompletedNCT02394028
Start: 2015-03-20End: 2021-09-07Updated: 2022-11-16
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
TerminatedNCT02403323
Start: 2015-06-08End: 2023-10-09Updated: 2024-12-02
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY
TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE
CROHN*S DISEASE
Active, not recruitingNL-OMON47704
Start: 2015-12-02Target: 23Updated: 2024-02-28
AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH
MODERATELY TO SEVERELY ACTIVE CROHN*S DISEASE PREVIOUSLY ENROLLED
IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144
RecruitingNL-OMON47567
Start: 2016-07-08Target: 23Updated: 2024-02-28