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

NCT00997100 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-06-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Active Biotech AB

    lead INDUSTRY

Principal Investigators

  • Marie Wallén Öhman, Ph.D. · Active Biotech AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00997100 on ClinicalTrials.gov