Clinical trial NCT02533570: Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
Official title: A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number and Percentage of Subjects Having an Adverse Event (AE)
timeFrame: Up to 127 days (9 weeks after final dose)
Secondary outcomes:
measure: Proportion of Subjects Achieving an SRI Response at Day 85
timeFrame: 85 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - (UAB)
state: Alabama
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: La Palma
country: United States
facility: Advanced Medical Research, LLC
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida - Corporate
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research, LLC
state: Florida
city: Orlando
country: United States
facility: Arthritis Associates
state: Florida
city: Tampa
country: United States
facility: McIlwain Medical Group
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Clayton Medical Associates, P.C.
state: Missouri
city: Brooklyn
country: United States
facility: Weill Cornell Physicians at Brooklyn Heights
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklahoma
state: Oklahoma
city: Memphis
country: United States
facility: Ramesh C Gupta MD
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Arlington
country: United States
facility: Arthritis Clinic of Northern Virginia, PC
state: Virginia
Study officials:
affiliation: Seattle Genetics Medical Monitor
name: Steve Sesterhenn, MD
role: STUDY_DIRECTOR
References: