Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

May 11, 2018 updated by: Seagen Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham - (UAB)
    • California
      • El Cajon, California, United States, 92020-4124
        • TriWest Research Associates, LLC
      • La Palma, California, United States, 90623
        • Advanced Medical Research, LLC
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida - Corporate
      • Miami Lakes, Florida, United States, 33014
        • Lakes Research, LLC
      • Orlando, Florida, United States, 32804
        • Arthritis Associates
      • Tampa, Florida, United States, 33613
        • McIlwain Medical Group
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Clayton Medical Associates, P.C.
    • New York
      • Brooklyn, New York, United States, 11201
        • Weill Cornell Physicians At Brooklyn Heights
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • DJL Clinical Research, PLLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Arthritis & Rheumatology Center of Oklahoma
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Ramesh C Gupta MD
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc.
      • Houston, Texas, United States, 77034
        • Accurate Clinical Research
    • Virginia
      • Arlington, Virginia, United States, 22205-3606
        • Arthritis Clinic of Northern Virginia, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Experimental: Brentuximab vedotin
4 dose groups
Drug: Brentuximab vedotin
Other Names:
  • ADCETRIS (brentuximab vedotin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Percentage of Subjects Having an Adverse Event (AE)
Time Frame: 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.
Up to 127 days (9 weeks after final dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Achieving an SRI Response at Day 85
Time Frame: 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
85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Steve Sesterhenn, MD, Seattle Genetics Medical Monitor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

June 5, 2017

Study Completion (Actual)

June 5, 2017

Study Registration Dates

First Submitted

July 9, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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