Etrolizumab

Generic Name: Etrolizumab

Brand Names: -

Drug Type: Biotech

Chemical Formula: -

CAS Number: 1044758-60-2

Unique Ingredient Identifier: I2A72G2V3J

Background: 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.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

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

Phase 1

Terminated

Conditions: Ulcerative Colitis
Crohn's Disease

Interventions: Drug: Etrolizumab

First Posted Date: 2018-03-27

Last Posted Date: 2023-12-01

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 24

Registration Number: NCT03478956

Locations: 🇵🇱
Centrum Zdrowia MDM, Warszawa, Poland
🇪🇸
Hospital Niño Jesus; Servicio de Pediatria - Gastrenterologia y Nutricion, Madrid, Spain
🇬🇧
Royal Manchester Childrens Hospital, Manchester, United Kingdom

and more 2 locations

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)

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Etrolizumab
Device: Auto-Injector (AI)
Device: Prefilled Syringe With Needle Safety Device (PFS-NSD)

First Posted Date: 2016-12-19

Last Posted Date: 2018-12-03

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 180

Registration Number: NCT02996019

Locations: 🇺🇸
Covance Research Unit - Daytona, Daytona Beach, Florida, United States
🇺🇸
Covance Clinical Research Unit Inc.; Covance Gfi Research, Evansville, Indiana, United States
🇺🇸
Covance Clinical Research Unit, Inc, Madison, Wisconsin, United States

and more 1 locations

A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Etrolizumab
Device: Prefilled Auto-injector (Rotaject)

First Posted Date: 2015-12-14

Last Posted Date: 2016-11-02

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 27

Registration Number: NCT02629744

Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

Phase 3

Terminated

Conditions: Crohn Disease

Interventions: Drug: Etrolizumab

First Posted Date: 2015-03-31

Last Posted Date: 2024-12-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 790

Registration Number: NCT02403323

Locations: 🇭🇺
Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika, Budapest, Hungary
🇺🇸
Valley Gastroenterology Consultants, Arcadia, California, United States
🇺🇸
University of California San Diego Medical Center, La Jolla, California, United States

and more 284 locations

A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease

Phase 3

Completed

Conditions: Crohn Disease

Interventions: Drug: Etrolizumab
Drug: Placebo

First Posted Date: 2015-03-20

Last Posted Date: 2022-11-16

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1035

Registration Number: NCT02394028

Locations: 🇺🇸
Innovative Medical Research of South Florida, Aventura, Florida, United States
🇦🇹
LKH - Universitätsklinikum der PMU Salzburg, Salzburg, Austria
🇭🇷
Clinical Hospital Center Sestre Milosrdnice, Zagreb, Croatia

and more 324 locations

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

Phase 3

Completed

Conditions: Ulcerative Colitis

Interventions: Other: Adalimumab Placebo
Drug: Adalimumab
Other: Etrolizumab Placebo
Drug: Etrolizumab

First Posted Date: 2014-06-24

Last Posted Date: 2021-07-23

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 358

Registration Number: NCT02171429

Locations: 🇧🇬
Medical center Medconsult Pleven OOD, Pleven, Bulgaria
🇦🇷
Centro de Investigaciones Medicas Mar Del Plata, Mar del Plata, Argentina
🇧🇬
DCC Sv. Pantaleymon OOD, Pleven, Bulgaria

and more 87 locations

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

Phase 3

Completed

Conditions: Colitis, Ulcerative

Interventions: Drug: Placebo
Drug: Etrolizumab

First Posted Date: 2014-06-17

Last Posted Date: 2021-08-19

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 359

Registration Number: NCT02165215

Locations: 🇺🇸
Shafran Gastroenterology Center, Winter Park, Florida, United States
🇺🇸
Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology, Chicago, Illinois, United States
🇺🇸
Southwest Gastroenterology, Oak Lawn, Illinois, United States

and more 101 locations

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

Phase 3

Completed

Conditions: Ulcerative Colitis

Interventions: Other: Adalimumab Placebo
Drug: Adalimumab
Other: Etrolizumab Placebo
Drug: Etrolizumab

First Posted Date: 2014-06-16

Last Posted Date: 2021-07-23

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 358

Registration Number: NCT02163759

Locations: 🇵🇱
EMC Instytut Medyczny S.A., Wrocław, Poland
🇵🇱
AppleTreeClinics Sp. z o.o., Łódź, Poland
🇪🇪
Tartu University Hospital, Tartu, Estonia

and more 85 locations

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

Phase 3

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: Etrolizumab
Drug: Infliximab
Other: Placebo (IV)
Other: Placebo (Injection)

First Posted Date: 2014-05-12

Last Posted Date: 2021-12-03

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 397

Registration Number: NCT02136069

Locations: 🇮🇱
Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit, Tel Hashomer, Israel
🇭🇺
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo, Budapest, Hungary
🇭🇺
Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft, Debrecen, Hungary

and more 116 locations

Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

Phase 3

Terminated

Conditions: Ulcerative Colitis

Interventions: Drug: Etrolizumab

First Posted Date: 2014-04-21

Last Posted Date: 2024-10-23

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1822

Registration Number: NCT02118584

Locations: 🇩🇰
Rigshospitalet; Afdeling for Tarmsvigt og Leversygdomme, København Ø, Denmark
🇭🇺
Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika, Budapest, Hungary
🇺🇸
University of Alabama Medical Center, Birmingham, Alabama, United States

and more 408 locations

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