NCT01461317 is a Phase 2 clinical trial of Etrolizumab in Ulcerative Colitis, sponsored by Genentech, Inc..

Who is sponsoring NCT01461317?

NCT01461317 is sponsored by Genentech, Inc..

What drugs are being tested in NCT01461317?

Interventions in NCT01461317: Etrolizumab.

What condition does NCT01461317 study?

NCT01461317 studies Ulcerative Colitis.

Is NCT01461317 still recruiting?

NCT01461317 is currently completed. Last updated 10 February 2020.

Last reviewed 2020-02-10 · How we verify

NCT01461317

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis

Completed Phase 2 Last updated 10 February 2020

What this trial tests

Phase 2 trial testing Etrolizumab in Ulcerative Colitis in 121 participants. Completed in 7 August 2016.

Timeline

29 November 2011

Primary endpoint
7 August 2016

7 August 2016

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	121
Start date	29 November 2011
Primary completion	7 August 2016
Estimated completion	7 August 2016
Sites	40 locations across New Zealand, Belgium, United Kingdom, Germany, Hungary, Israel, Canada, Australia

Drugs / interventions tested

Etrolizumab — full drug profile →

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Genentech, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Vedolizumab for the treatment of ulcerative colitis and Crohn's disease.
McLean LP, Shea-Donohue T, Cross RK. · · 2012 · cited 77× · PMID 23046232 · DOI 10.2217/imt.12.85
Review article: nonclinical and clinical pharmacology, pharmacokinetics and pharmacodynamics of etrolizumab, an anti-β7 integrin therapy for inflammatory bowel disease.
Tang MT, Keir ME, Erickson R, Stefanich EG, et al · · 2018 · cited 30× · PMID 29601644 · DOI 10.1111/apt.14631
Frontiers in Drug Research and Development for Inflammatory Bowel Disease.
Currò D, Pugliese D, Armuzzi A. · · 2017 · cited 30× · PMID 28690543 · DOI 10.3389/fphar.2017.00400
The clinical potential of etrolizumab in ulcerative colitis: hypes and hopes.
Fiorino G, Gilardi D, Danese S. · · 2016 · cited 14× · PMID 27366219 · DOI 10.1177/1756283x16647935
Emerging pharmacologic therapies for primary sclerosing cholangitis.
Cheung AC, Lazaridis KN, LaRusso NF, Gores GJ. · · 2017 · cited 9× · PMID 28257308 · DOI 10.1097/mog.0000000000000352
Etrolizumab for induction of remission in ulcerative colitis.
Rosenfeld G, Parker CE, MacDonald JK, Bressler B. · · 2015 · cited 6× · PMID 26630451 · DOI 10.1002/14651858.cd011661.pub2
Novel treatment options for ulcerative colitis.
Vaughn BP, Moss AC. · · 2013 · cited 5× · PMID 24533177 · DOI 10.4155/cli.13.97

Verify or expand the search:

Other trials of Etrolizumab

Trials testing the same drug.

NCT03478956 — A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderat · Phase 1 · terminated
NCT02996019 — A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle S · Phase 1 · completed
NCT02403323 — Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase · Phase 3 · terminated
NCT02394028 — A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely A · Phase 3 · completed
NCT02136069 — A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerativ · Phase 3 · completed

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Genentech, Inc. trials

Trials by the same sponsor.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07448038 — A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vas · Phase 2 · recruiting
NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01461317 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
Last refreshed: 10 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01461317.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing