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Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

Primary Purpose

Systemic Lupus Erythematosus

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brentuximab vedotin
Placebo
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham - (UAB)
  • TriWest Research Associates, LLC
  • Advanced Medical Research, LLC
  • University of Colorado
  • Clinical Research of West Florida - Corporate
  • Lakes Research, LLC
  • Arthritis Associates
  • McIlwain Medical Group
  • Henry Ford Health System
  • Clayton Medical Associates, P.C.
  • Weill Cornell Physicians at Brooklyn Heights
  • DJL Clinical Research, PLLC
  • Arthritis & Rheumatology Center of Oklahoma
  • Ramesh C Gupta MD
  • Tekton Research, Inc.
  • Accurate Clinical Research
  • Arthritis Clinic of Northern Virginia, PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brentuximab vedotin

Placebo

Arm Description

4 dose groups

Matching placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2015
Last Updated
May 11, 2018
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02533570
Brief Title
Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
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 Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 5, 2017 (Actual)
Study Completion Date
June 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brentuximab vedotin
Arm Type
Experimental
Arm Description
4 dose groups
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Brentuximab vedotin
Other Intervention Name(s)
ADCETRIS (brentuximab vedotin)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number and Percentage of Subjects Having an Adverse Event (AE)
Description
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.
Time Frame
Up to 127 days (9 weeks after final dose)
Secondary Outcome Measure Information:
Title
Proportion of Subjects Achieving an SRI Response at Day 85
Description
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
Time Frame
85 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Sesterhenn, MD
Organizational Affiliation
Seattle Genetics Medical Monitor
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham - (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020-4124
Country
United States
Facility Name
Advanced Medical Research, LLC
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Clinical Research of West Florida - Corporate
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Lakes Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Arthritis Associates
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
McIlwain Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Clayton Medical Associates, P.C.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Weill Cornell Physicians at Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Arthritis & Rheumatology Center of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Ramesh C Gupta MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Arthritis Clinic of Northern Virginia, PC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205-3606
Country
United States

12. IPD Sharing Statement

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Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

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