Topics

Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis

2019-10-21 12:45:25 | BioPortfolio

Summary

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis

Description

The study will enroll up to 56 subjects, with up to 4 dose escalating cohorts of either 6 open-label (Type A-SLE) or 8 double-blind (Type B-Lupus Nephritis) subjects (enrolled in a 3:1 ratio). Subjects will receive itolizumab (Type A) or blinded itolizumab or placebo (Type B) administered subcutaneously every two weeks for a total of either 2 or 7 doses with 4 or 12 weeks of follow-up after the last dose of investigational product.

Study Design

Conditions

Lupus Erythematosus

Intervention

Itolizumab [Bmab 600], EQ001 Placebo

Location

Clinical Research of West Florida - Clearwater
Clearwater
Florida
United States
33765-2616

Status

Recruiting

Source

Equillium

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-21T12:45:25-0400

Clinical Trials [426 Associated Clinical Trials listed on BioPortfolio]

Evaluating the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Uncontrolled Asthma

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with moderate-to-severe asthma.

Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus

This clinical study will test the efficacy and safety of nicotinamide for lupus-associated skin lesions refractory to the treatment of hydroxychloroquine plus low-dose corticosteroids in p...

Safety Study of AMG 557 in Subjects With Lupus Arthritis

This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus...

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

The purpose of this study is to determine if AMG 570 could be a useful therapeutic agent in the current treatment landscape where subjects with systemic lupus erythematosus (SLE) have ongo...

Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with...

PubMed Articles [1159 Associated PubMed Articles listed on BioPortfolio]

Spectrum of cutaneous lupus erythematosus in South Africans with systemic lupus erythematosus.

Cutaneous involvement is very common in systemic lupus erythematosus. We describe the prevalence and spectrum of lupus-specific (cutaneous lupus erythematosus) and non-specific cutaneous features amon...

Analysis of brain metabolites by gas chromatography-mass spectrometry reveals the risk-benefit concerns of prednisone in MRL/lpr lupus mice.

Neuropsychiatric systemic lupus erythematosus (NPSLE) is a common cause of disability in systemic lupus erythematosus (SLE). This study aims to investigate the metabolic changes in the hypothalamus an...

A review of the evidence and cost of therapies for cutaneous lupus erythematosus.

Cutaneous lupus erythematosus (CLE)-a common presentation of lupus erythematosus-may exist independently or as a part of the systemic manifestations of systemic lupus erythematosus. The effects of liv...

Treatment target in newly diagnosed Systemic Lupus Erythematosus.

To compare the effect of achievement and maintenance of lupus low disease activity state (LLDAS) and clinical remission (CR) in preventing early damage accrual in patients with systemic lupus erythema...

Blood ceramides as novel markers for renal impairment in systemic lupus erythematosus.

Lupus nephritis (LN) is the most common organ manifestation in systemic lupus erythematosus (SLE) and associated with a poor prognosis. Still, a noninvasive but reliable method to diagnose LN has not ...

Medical and Biotech [MESH] Definitions

A form of lupus erythematosus in which the skin may be the only organ involved or in which skin involvement precedes the spread into other body systems. It has been classified into three forms - acute (= LUPUS ERYTHEMATOSUS, SYSTEMIC with skin lesions), subacute, and chronic (= LUPUS ERYTHEMATOSUS, DISCOID).

A type of lupus erythematosus characterized by deep dermal or subcutaneous nodules, most often on the head, face, or upper arms. It is generally chronic and occurs most often in women between the ages of 20 and 45.

A chronic form of cutaneous lupus erythematosus (LUPUS ERYTHEMATOSUS, CUTANEOUS) in which the skin lesions mimic those of the systemic form but in which systemic signs are rare. It is characterized by the presence of discoid skin plaques showing varying degrees of edema, erythema, scaliness, follicular plugging, and skin atrophy. Lesions are surrounded by an elevated erythematous border. The condition typically involves the face and scalp, but widespread dissemination may occur.

Antiphospholipid antibodies found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. The antibodies are detected by solid-phase IMMUNOASSAY employing the purified phospholipid antigen CARDIOLIPIN.

An antiphospholipid antibody found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. In vitro, the antibody interferes with the conversion of prothrombin to thrombin and prolongs the partial thromboplastin time. In vivo, it exerts a procoagulant effect resulting in thrombosis mainly in the larger veins and arteries. It further causes obstetrical complications, including fetal death and spontaneous abortion, as well as a variety of hematologic and neurologic complications.

More From BioPortfolio on "Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis"

Quick Search

Relevant Topics

Rheumatology
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Lupus
Lupus is a complex and poorly understood condition that affects many parts of the body and causes symptoms ranging from mild to life-threatening. There are several types of lupus. The main types are: discoid lupus erythematosus drug-induced lu...


Searches Linking to this Trial