Etrolizumab

Overview

Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, is typified by a chronic gastrointestinal inflammatory microenvironment, driven in part by the excessive infiltration and retention of intestinal-homing lymphocytes. A recent class of drugs designed to impair lymphocyte homing, so-called "anti-trafficking agents" (ATAs), have shown some success and include approved drugs such as natalizumab and vedolizumab, which target integrins and impair their interaction with adhesion molecules on epithelial cells. In the case of natalizumab, which targets the α4 integrin subunit, this has also resulted in undesirable blockade of lymphocyte CNS trafficking and reported cases of progressive multifocal leukoencephalopathy (PML). Etrolizumab is a humanized IgG1κ monoclonal antibody directed against the β7 subunit of gastrointestinal α4β7 and αEβ7 integrins that, due to its target specificity, appears as or more efficacious than vedolizumab and without the CNS effects of natalizumab. Etrolizumab is currently under investigation for the treatment of ulcerative colitis and Crohn's disease.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
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	2018/03/27	NCT03478956	Phase 1	Terminated	Hoffmann-La Roche
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)	2016/12/19	NCT02996019	Phase 1	Completed	Genentech, Inc.
A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants	2015/12/14	NCT02629744	Phase 1	Completed	Genentech, Inc.
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144	2015/03/31	NCT02403323	Phase 3	Terminated	Hoffmann-La Roche
A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease	2015/03/20	NCT02394028	Phase 3	Completed	Hoffmann-La Roche
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	2014/06/24	NCT02171429	Phase 3	Completed	Hoffmann-La Roche
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	2014/06/17	NCT02165215	Phase 3	Completed	Hoffmann-La Roche
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	2014/06/16	NCT02163759	Phase 3	Completed	Hoffmann-La Roche
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	2014/05/12	NCT02136069	Phase 3	Completed	Hoffmann-La Roche
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies	2014/04/21	NCT02118584	Phase 3	Terminated	Hoffmann-La Roche

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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