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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):
Seagen Inc.

Study Description
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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.
Study Design
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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

Arms and Interventions
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Arm Intervention/treatment
Experimental: Brentuximab vedotin
4 dose groups
 Drug: Brentuximab vedotin
Other Name: ADCETRIS (brentuximab vedotin)
Placebo Comparator: Placebo
Matching placebo
 Drug: Placebo


Outcome Measures
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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



Eligibility Criteria
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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
Contacts and Locations
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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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Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Steve Sesterhenn, MD Seattle Genetics Medical Monitor
  Study Documents (Full-Text)

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

More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT02533570    
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 Seagen Inc.:
Lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Brentuximab Vedotin
 Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs