Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Drug: Placebo
- Registration Number
- NCT02533570
- Lead Sponsor
- Seagen Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brentuximab vedotin Brentuximab vedotin 4 dose groups Placebo Placebo Matching placebo
- Primary Outcome Measures
Name Time Method Number and Percentage of Subjects Having an Adverse Event (AE) Up to 127 days (9 weeks after final dose) 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.
- Secondary Outcome Measures
Name Time Method Proportion of Subjects Achieving an SRI Response at Day 85 85 days 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
Trial Locations
- Locations (17)
Clayton Medical Associates, P.C.
🇺🇸Saint Louis, Missouri, United States
TriWest Research Associates, LLC
🇺🇸El Cajon, California, United States
Lakes Research, LLC
🇺🇸Miami Lakes, Florida, United States
Weill Cornell Physicians at Brooklyn Heights
🇺🇸Brooklyn, New York, United States
University of Alabama at Birmingham - (UAB)
🇺🇸Birmingham, Alabama, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Arthritis & Rheumatology Center of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Accurate Clinical Research
🇺🇸Houston, Texas, United States
Clinical Research of West Florida - Corporate
🇺🇸Clearwater, Florida, United States
DJL Clinical Research, PLLC
🇺🇸Charlotte, North Carolina, United States
Arthritis Clinic of Northern Virginia, PC
🇺🇸Arlington, Virginia, United States
Ramesh C Gupta MD
🇺🇸Memphis, Tennessee, United States
Arthritis Associates
🇺🇸Orlando, Florida, United States
Advanced Medical Research, LLC
🇺🇸La Palma, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Tekton Research, Inc.
🇺🇸Austin, Texas, United States
McIlwain Medical Group
🇺🇸Tampa, Florida, United States