|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02533570 |
|
Date of registration:
|
09/07/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
|
|
Scientific title:
|
A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus |
|
Date of first enrolment:
|
July 2015 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT02533570 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Steve Sesterhenn, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Seattle Genetics Medical Monitor |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Systemic Lupus Erythematosus
|
|
Intervention(s)
|
|
Drug: Brentuximab vedotin
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
[Time Frame: Up to 127 days (9 weeks after final dose)]
|
|
Secondary Outcome(s)
|
|
Proportion of Subjects Achieving an SRI Response at Day 85
[Time Frame: 85 days]
|
|
Secondary ID(s)
|
|
SGN35-022
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|