11 completed, 3 terminated. 8 Phase 3, 4 Phase 1, 2 Phase 2.
By phase and status
Follow etrolizumab: new trials by email Literature Review of etrolizumab trials Research Report on etrolizumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
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 Etrolizumab - Ulcerative Colitis, Crohn's Disease | Phase 1 | Terminated | Hoffmann-La Roche | 24 | 2018-03-27 | 2024-12-27 |
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) Etrolizumab, Auto-Injector (AI), Prefilled Syringe With Needle Safety Device (PFS-NSD) - Healthy Volunteers | Phase 1 | Completed | Genentech, Inc. | 180 | 2016-12-07 | 2018-12-03 |
A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants Etrolizumab, Prefilled Auto-injector (Rotaject) - Healthy Volunteer | Phase 1 | Completed | Genentech, Inc. | 27 | 2015-12-01 | 2016-11-02 |
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 Etrolizumab - Crohn Disease | Phase 3 | Terminated | Hoffmann-La Roche | 790 | 2015-06-08 | 2024-12-02 |
A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease Etrolizumab, Placebo - Crohn Disease | Phase 3 | Completed | Hoffmann-La Roche | 1035 | 2015-03-20 | 2022-11-16 |
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 Etrolizumab, Infliximab, Placebo (IV) - Ulcerative Colitis | Phase 3 | Completed | Hoffmann-La Roche | 397 | 2014-12-24 | 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 Adalimumab, Adalimumab Placebo, Etrolizumab - Ulcerative Colitis | Phase 3 | Completed | Hoffmann-La Roche | 358 | 2014-11-14 | 2021-07-23 |
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 Adalimumab, Adalimumab Placebo, Etrolizumab - Ulcerative Colitis | Phase 3 | Completed | Hoffmann-La Roche | 358 | 2014-11-04 | 2021-07-23 |
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies Etrolizumab - Ulcerative Colitis | Phase 3 | Terminated | Hoffmann-La Roche | 1822 | 2014-09-15 | 2024-10-23 |
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 Etrolizumab, Placebo - Colitis, Ulcerative | Phase 3 | Completed | Hoffmann-La Roche | 359 | 2014-08-12 | 2021-08-19 |
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors Etrozulimab, Placebo - Ulcerative Colitis | Phase 3 | Completed | Hoffmann-La Roche | 609 | 2014-05-21 | 2021-08-13 |
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis Etrolizumab - Ulcerative Colitis | Phase 2 | Completed | Genentech, Inc. | 121 | 2011-11-29 | 2020-02-10 |
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis placebo, rhuMAb Beta7 - Ulcerative Colitis | Phase 2 | Completed | Genentech, Inc. | 124 | 2011-09-01 | 2016-08-12 |
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis placebo, rhuMAb Beta7 - Ulcerative Colitis | Phase 1 | Completed | Genentech, Inc. | 48 | 2008-09-01 | 2016-11-02 |
Conditions studied
Colitis, Ulcerative (10) · Crohn Disease (3)
Sponsors
Hoffmann-La Roche (9) · Genentech, Inc. (5)
Countries
United States (12) · Belgium (9) · Canada (9) · Czechia (9) · Germany (9) · Hungary (9) · United Kingdom (9) · Australia (8) · Israel (8) · Poland (8) · Spain (8) · Brazil (7) · France (7) · Argentina (6) · Italy (6)
Top investigators
Sharon O'Byrne, M.D. (1)
Results publications
PMID 32445184, PMID 34798036, PMID 41841037, PMID 24814090, PMID 32464142, PMID 33778928, PMID 33778929, PMID 34467254, PMID 34798037, PMID 34798038, PMID 34798039, PMID 36240801, PMID 42436336
NIH funding
2014 (2), 2017 (1)