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Trial record 47 of 906 for:    Lupus

Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02533570
Recruitment Status : Terminated (Sponsor decision based on portfolio prioritization)
First Posted : August 27, 2015
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, 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).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Brentuximab vedotin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2015
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : June 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Brentuximab vedotin
4 dose groups
Drug: Brentuximab vedotin
Other Name: ADCETRIS (brentuximab vedotin)

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533570


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

Documents provided by Seattle Genetics, Inc.:
Study Protocol  [PDF] July 25, 2016
Statistical Analysis Plan  [PDF] January 31, 2017


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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02533570     History of Changes
Other Study ID Numbers: SGN35-022
First Posted: August 27, 2015    Key Record Dates
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018
Last Verified: May 2018
Keywords provided by Seattle Genetics, Inc.:
Lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs