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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):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE July 9, 2015
First Posted Date  ICMJE August 27, 2015
Results First Submitted Date  ICMJE May 11, 2018
Results First Posted Date  ICMJE June 11, 2018
Last Update Posted Date June 11, 2018
Study Start Date  ICMJE July 2015
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2015)
Number and percentage of subjects having an Adverse Event [ Time Frame: 127 days ]
Change History Complete list of historical versions of study NCT02533570 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2015)
  • Proportion of subjects achieving a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) clinical response defined by a ≥ 4 point improvement from baseline [ Time Frame: 85 days ]
  • Maximum observed concentration (Cmax) of Brentuximab vedotin and metabolites total antibody (TAb), and monomethyl auristatin E (MMAE) [ Time Frame: Days 1 (pre- and post-dose), 2, 3, 8, 15, 22 (pre- and post-dose), 43 (pre- and post-dose), 64 (pre- and post-dose), 85, 106 and 127 of the study ]
  • Area under the concentration-time curve (AUC) of Brentuximab vedotin and metabolites Tab, MMAE [ Time Frame: days 1 (pre- and post-dose), 2, 3, 8, 15, 22 (pre- and post-dose), 43 (pre- and post-dose), 64 (pre- and post-dose), 85, 106 and 127 of the study ]
  • Clearance (CL) of Brentuximab vedotin and metabolites Tab, MMAE [ Time Frame: Days 1 (pre- and post-dose), 2, 3, 8, 15, 22 (pre- and post-dose), 43 (pre- and post-dose), 64 (pre- and post-dose), 85, 106 and 127 of the study ]
  • Half-life (t1/2); of Brentuximab vedotin and metabolites Tab, MMAE [ Time Frame: Days 1 (pre- and post-dose), 2, 3, 8, 15, 22 (pre- and post-dose), 43 (pre- and post-dose), 64 (pre- and post-dose), 85, 106 and 127 of the study ]
  • Incidence of anti-therapeutic antibodies (ATA) [ Time Frame: Days 1, 22, 43, 64, 85, 106 and 107 of the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
Official Title  ICMJE A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Brentuximab vedotin
    Other Name: ADCETRIS (brentuximab vedotin)
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Brentuximab vedotin
    4 dose groups
    Intervention: Drug: Brentuximab vedotin
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 23, 2017)
20
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2015)
40
Actual Study Completion Date  ICMJE June 5, 2017
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02533570
Other Study ID Numbers  ICMJE SGN35-022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steve Sesterhenn, MD Seattle Genetics Medical Monitor
PRS Account Seattle Genetics, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP