Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

Phase 2TerminatedNCT02533570

Seagen Inc.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

Brentuximab vedotinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

University of Alabama at Birmingham - (UAB)

Birmingham, Alabama, United States

TriWest Research Associates, LLC

El Cajon, California, United States

Outcomes

Primary Outcomes

Number and Percentage of Subjects Having an Adverse Event (AE)

Any treatment-emergent adverse events (TEAEs), any drug-related TEAEs, any SAEs, treatment-related serious adverse events (SAE), deaths, adverse events (AEs) leading to study discontinuation, and number of patients experiencing Grade 1, 2, and 3 TEAEs.

Time frame: Up to 127 days (9 weeks after final dose)

Secondary Outcomes

Proportion of Subjects Achieving an SRI Response at Day 85

Assessment for response was made using data only for the visit of interest (Day 85), without regard for changes at prior on-treatment visits. SRI: SLE Responder Index; SLE: Systemic lupus erythematosus

Time frame: 85 days

Data from ClinicalTrials.gov

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