Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT02533570

Run by

Seagen Inc.

People needed

20

Starts

2015-07-01

Expected to finish

2017-06-05

Last updated by the study team

2018-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham - (UAB) — Birmingham, Alabama, United States
• TriWest Research Associates, LLC — El Cajon, California, United States
• Advanced Medical Research, LLC — La Palma, California, United States
• University of Colorado — Aurora, Colorado, United States
• Clinical Research of West Florida - Corporate — Clearwater, Florida, United States
• Lakes Research, LLC — Miami Lakes, Florida, United States
• Arthritis Associates — Orlando, Florida, United States
• McIlwain Medical Group — Tampa, Florida, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Clayton Medical Associates, P.C. — St Louis, Missouri, United States
• Weill Cornell Physicians at Brooklyn Heights — Brooklyn, New York, United States
• DJL Clinical Research, PLLC — Charlotte, North Carolina, United States
• Arthritis & Rheumatology Center of Oklahoma — Oklahoma City, Oklahoma, United States
• Ramesh C Gupta MD — Memphis, Tennessee, United States
• Tekton Research, Inc. — Austin, Texas, United States
• Accurate Clinical Research — Houston, Texas, United States
• Arthritis Clinic of Northern Virginia, PC — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

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