Ignite Creation Date:
2024-05-05 @ 9:55 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00997100
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2009-10-16
Brief Title:
Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus SLE
Sponsor:
Active Biotech AB
Organization:
Active Biotech AB
Study Overview
Official Title:
An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus SLE
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an exploratory open label single arm study to evaluate changes in disease activity and biomarkers in patients with mild active SLE during treatment with ABR-215757 given as add-on to standard therapy To be eligible for the study SLE patients should present with symptoms from skin mouth andor joints After a screening period of one week patients will be treated with ABR-215757 for 12 weeks The initial dose of ABR-215757 will be 15 mgday There will be an option to increase the dose to 30 mgday following 28 days of treatment Follow-up visits will take place 4 weeks and 8 weeks after last day of treatment Disease activity during treatment will be studied using the Systemic Lupus Erythematosus disease Activity Index SLEDAI-2K as well as organ system specific disease activity indexes CLASI for skin involvement and number of swollentender joints using 28- and 6668-joint counts At specified time points during the study blood samples and biopsies will be collected for analysis of established and exploratory biomarkers of SLE Concomitant SLE treatment allowed include prednisolone or equivalent at a dose of 15 mgday hydroxychloroquine azathioprine methotrexate and mycophenolate mofetil all at stable doses from specified timepoints prior to the study and throughout the study
Detailed Description:
All patients will initially receive ABR-215757 at 15 mgday There will be an option to increase the dose to 30 mgday following 28 days of treatment The selected dose levels 15 and 30 mgday ABR-215757 are predicted to be effective based on preclinical studies of autoimmune disease including the SLE MRL model Previous experience in humans as well as in preclinical models supports safe administration of ABR-215757 at doses up to and including 30 mgday The duration of the study is expected to be sufficient to detect changes in disease activity in this group of patients Near steady state plasma levels of ABR-215757 in humans are reached in 14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-011245-55 | EUDRACT_NUMBER | None | None |