NCT00997100

Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Active Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 and/or 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 1.5 mg/day. There will be an option to increase the dose to 3.0 mg/day 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 swollen/tender joints using 28- and 66/68-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 mg/day, 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 1.5 mg/day. There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment. The selected dose levels (1.5 and 3.0 mg/day 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 3.0 mg/day. 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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	paquinimod (ABR-215757)	The initial daily dose of ABR-215757 is changed to 1.5 mg/day. There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-10-19
• Last updated: 2015-06-25

Locations

4 sites across 2 countries: Denmark, Sweden