Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02533570
• Other study ID #: SGN35-022
• Status: Terminated
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: June 5, 2017

Study information

• Verified date: May 2018
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 5, 2017
• Est. primary completion date: June 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Brentuximab vedotin

• Placebo

Locations

Country	Name	City	State
United States	Arthritis Clinic of Northern Virginia, PC	Arlington	Virginia
United States	University of Colorado	Aurora	Colorado
United States	Tekton Research, Inc.	Austin	Texas
United States	University of Alabama at Birmingham - (UAB)	Birmingham	Alabama
United States	Weill Cornell Physicians at Brooklyn Heights	Brooklyn	New York
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Clinical Research of West Florida - Corporate	Clearwater	Florida
United States	Henry Ford Health System	Detroit	Michigan
United States	TriWest Research Associates, LLC	El Cajon	California
United States	Accurate Clinical Research	Houston	Texas
United States	Advanced Medical Research, LLC	La Palma	California
United States	Ramesh C Gupta MD	Memphis	Tennessee
United States	Lakes Research, LLC	Miami Lakes	Florida
United States	Arthritis & Rheumatology Center of Oklahoma	Oklahoma City	Oklahoma
United States	Arthritis Associates	Orlando	Florida
United States	Clayton Medical Associates, P.C.	Saint Louis	Missouri
United States	McIlwain Medical Group	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 127 days (9 weeks after final dose)
Secondary	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	85 days