Study Stopped
Sponsor decision based on portfolio prioritization
Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus
1 other identifier
interventional
20
1 country
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2015
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 9, 2015
CompletedFirst Posted
Study publicly available on registry
August 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2017
CompletedResults Posted
Study results publicly available
June 11, 2018
CompletedJune 11, 2018
May 1, 2018
1.9 years
July 9, 2015
May 11, 2018
May 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 127 days (9 weeks after final dose)
Secondary Outcomes (1)
Proportion of Subjects Achieving an SRI Response at Day 85
85 days
Study Arms (2)
Brentuximab vedotin
EXPERIMENTAL4 dose groups
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (17)
University of Alabama at Birmingham - (UAB)
Birmingham, Alabama, 35294, United States
TriWest Research Associates, LLC
El Cajon, California, 92020-4124, United States
Advanced Medical Research, LLC
La Palma, California, 90623, United States
University of Colorado
Aurora, Colorado, 80045, United States
Clinical Research of West Florida - Corporate
Clearwater, Florida, 33765, United States
Lakes Research, LLC
Miami Lakes, Florida, 33014, United States
Arthritis Associates
Orlando, Florida, 32804, United States
McIlwain Medical Group
Tampa, Florida, 33613, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Clayton Medical Associates, P.C.
St Louis, Missouri, 63117, United States
Weill Cornell Physicians at Brooklyn Heights
Brooklyn, New York, 11201, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210, United States
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Ramesh C Gupta MD
Memphis, Tennessee, 38119, United States
Tekton Research, Inc.
Austin, Texas, 78745, United States
Accurate Clinical Research
Houston, Texas, 77034, United States
Arthritis Clinic of Northern Virginia, PC
Arlington, Virginia, 22205-3606, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Seattle Genetics, Inc
Study Officials
- STUDY DIRECTOR
Steve Sesterhenn, MD
Seattle Genetics Medical Monitor
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2015
First Posted
August 27, 2015
Study Start
July 1, 2015
Primary Completion
June 5, 2017
Study Completion
June 5, 2017
Last Updated
June 11, 2018
Results First Posted
June 11, 2018
Record last verified: 2018-05