Epratuzumab

Generic Name: Epratuzumab

Brand Names: -

Drug Type: Biotech

Chemical Formula: -

CAS Number: 205923-57-5

Unique Ingredient Identifier: 3062P60MH9

Background: Epratuzumab is a humanized monoclonal antibody derived from the murine IG2a monoclonal antibody, LL2 (EPB-2). This agent may subsequently be well matched for use in oncology and the treatment of inflammatory autoimmune disorders, such as lupus.

Indication: Investigated for use/treatment in leukemia (lymphoid), lymphoma (non-hodgkin's), and systemic lupus erythematosus.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

Phase 3

Completed

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Epratuzumab

First Posted Date: 2011-08-03

Last Posted Date: 2018-10-03

Lead Sponsor: UCB Pharma

Target Recruit Count: 1250

Registration Number: NCT01408576

Locations: 🇺🇸
053, New York, New York, United States
🇮🇱
381, Jerusalem, Israel
🇷🇺
285, Petrozavodsk, Russian Federation

and more 225 locations

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

Phase 3

Completed

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Epratuzumab
Drug: Placebo

First Posted Date: 2010-12-17

Last Posted Date: 2018-09-28

Lead Sponsor: UCB Pharma

Target Recruit Count: 793

Registration Number: NCT01262365

Locations: 🇧🇷
455, Campinas, Brazil
🇺🇸
031, Los Angeles, California, United States
🇺🇸
040, Baltimore, Maryland, United States

and more 138 locations

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)

Phase 3

Completed

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Placebo
Drug: Epratuzumab

First Posted Date: 2010-12-16

Last Posted Date: 2020-12-04

Lead Sponsor: UCB Pharma

Target Recruit Count: 791

Registration Number: NCT01261793

Locations: 🇭🇺
715, Szeged, Hungary
🇮🇹
648, Milano, Italy
🇮🇹
646, Roma, Italy

and more 130 locations

Multi-centric Study

Phase 2

Completed

Conditions: B ALL
CD22+ Expression
Refractory B-ALL

Interventions: Drug: Epratuzumab

First Posted Date: 2010-10-13

Last Posted Date: 2018-02-27

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 57

Registration Number: NCT01219816

Locations: 🇫🇷
Purpan Hospital, Toulouse, France
🇫🇷
Nantes University Hospital, Nantes, France
🇫🇷
CHU de Poitiers, Poitiers, France

and more 8 locations

Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL)

Phase 2

Terminated

Conditions: Leukemia
Pediatric Cancer

Interventions: Drug: Epratuzumab
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Mesna
Procedure: Infusion of NK cells
Drug: Interleukin-2

First Posted Date: 2009-07-20

Last Posted Date: 2014-05-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 2

Registration Number: NCT00941928

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment

Not Applicable

Completed

Conditions: Lymphoma, Non-Hodgkin
Lymphomas: Non-Hodgkin
Lymphomas: Non-Hodgkin Cutaneous Lymphoma
Lymphomas: Non-Hodgkin Diffuse Large B-Cell
Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell
Lymphomas: Non-Hodgkin Mantle Cell
Lymphomas: Non-Hodgkin Marginal Zone
Lymphomas: Non-Hodgkin Peripheral T-Cell
Lymphomas: Non-Hodgkin Waldenstr Macroglobulinemia

First Posted Date: 2006-11-10

Last Posted Date: 2011-06-02

Lead Sponsor: Stanford University

Target Recruit Count: 500

Registration Number: NCT00398372

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Phase 3

Terminated

Conditions: Systemic Lupus Erythematosus

Interventions: Other: Placebo
Drug: Epratuzumab

First Posted Date: 2006-10-03

Last Posted Date: 2012-06-07

Lead Sponsor: UCB Pharma

Target Recruit Count: 54

Registration Number: NCT00383214

Study of Epratuzumab in Systemic Lupus Erythematosus

Phase 3

Withdrawn

Conditions: Systemic Lupus Erythematosus

First Posted Date: 2006-10-02

Last Posted Date: 2014-05-21

Lead Sponsor: UCB Pharma

Registration Number: NCT00382837

Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Phase 2

Terminated

Conditions: Lupus Erythematosus, Systemic

First Posted Date: 2005-06-13

Last Posted Date: 2012-04-03

Lead Sponsor: UCB Pharma

Target Recruit Count: 20

Registration Number: NCT00113971

Locations: 🇺🇸
Columbia Presbyterian Medical Center, New York, New York, United States
🇺🇸
Lupus Center of Excellence, Pittsburgh, Pennsylvania, United States
🇺🇸
Rheumatology Associates, Charleston, South Carolina, United States

Study of Epratuzumab in Systemic Lupus Erythematosus

Phase 3

Terminated

Conditions: Systemic Lupus Erythematosus

First Posted Date: 2005-05-20

Last Posted Date: 2011-11-08

Lead Sponsor: UCB Pharma

Target Recruit Count: 510

Registration Number: NCT00111306

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