Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus



Status:Terminated
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:6/13/2018
Start Date:July 2015
End Date:June 5, 2017

Use our guide to learn which trials are right for you!

A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin
in adults with active systemic lupus erythematosus (SLE).

Systemic lupus erythematosus (SLE) is a chronic, multisystem, disabling autoimmune condition,
which predominantly affects women of childbearing years. Treatment options for SLE remain
relatively limited. Regardless of the specific therapy chosen, the majority of patients
continue to require long term immunomodulatory or cytotoxic therapy, resulting in long-term
morbidity and mortality. Brentuximab vedotin is an antibody-drug conjugate (ADC) consisting
of: 1) the chimeric immunoglobulin (Ig) G1 antibody cAC10, specific for human CD30, 2) the
microtubule disrupting agent monomethyl auristatin E (MMAE), and 3) a protease-cleavable
linker that covalently attaches MMAE to cAC10. Since CD30 and/or CD30-expressing immune cells
may play significant key roles in the pathogenesis of SLE, brentuximab vedotin may be an
efficacious therapy. This study intends to explore the potential for brentuximab vedotin as a
therapy for SLE.

Inclusion Criteria:

- Adults ≥ 18 years

- Diagnosis of SLE for at least 6 months prior to screening

- Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening

- Must have failed a treatment for SLE after a trial of at least 3 months

Exclusion Criteria:

- The subject has any serious health condition, which, in the opinion of the
Investigator, would place the subject at undue risk from the study

- Subject has had recent serious or ongoing infection, or risk for serious infection

- Subject has a history of new or recurrent malignancy within the past 5 years

- The subject is pregnant and/or breastfeeding

- The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that
may confound clinical assessments in the study

- The subject has urgent, severe SLE disease activity, which, in the opinion of the
Investigator, warrants immediate immunosuppressive therapy and would not be
appropriate for the study
We found this trial at
17
sites
Arlington, Virginia 22205
Principal Investigator: Phillip Kempf, MD
Phone: 703-525-3069
?
mi
from
Arlington, VA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78745
Principal Investigator: Paul Pickrell, MD
Phone: 512-388-5717
?
mi
from
Austin, TX
Click here to add this to my saved trials
Birmingham, Alabama 35294
Principal Investigator: Walter Chatham, MD
Phone: 205-934-4212
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28210
Principal Investigator: Emily Jane Box, MD
Phone: 704-247-9179
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Clearwater, Florida 33765
Principal Investigator: Robert Levin, MD
Phone: 727-466-0078
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
El Cajon, California 92020
Principal Investigator: Arthur Mabaquiao, MD
Phone: 619-334-4735
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
Houston, Texas
Principal Investigator: Philip Waller, MD
Phone: 281-481-8557
?
mi
from
Houston, TX
Click here to add this to my saved trials
La Palma, California 90623
Principal Investigator: Gerald Ho, MD
Phone: 562-867-8195
?
mi
from
La Palma, CA
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami Lakes, Florida 33014
Principal Investigator: Benedicto Fernandez, MD
Phone: 786-362-5763
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
Principal Investigator: Mohammad Khan, MD
Phone: 405-606-8730
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32804
Principal Investigator: Jeffrey Poiley, MD
Phone: 407-271-8030
?
mi
from
Orlando, FL
Click here to add this to my saved trials
6400 Clayton Road
Saint Louis, Missouri 63117
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Tampa, Florida 33613
Principal Investigator: Harris McIlwain, MD
Phone: 813-345-2380
?
mi
from
Tampa, FL
Click here to add this to my saved trials