NCT02533570

Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Brentuximab vedotin
DRUG	Placebo

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-06-05
• Completion: 2017-06-05
• First posted: 2015-08-27
• Last updated: 2018-06-11
• Results posted: 2018-06-11

Locations

17 sites across 1 country: United States