Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

• Status: Terminated
• Trial end date: 2017-06-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Antibodies, Monoclonal; Brentuximab Vedotin

Criteria

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