- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00997100
Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)
June 24, 2015 updated by: Active Biotech AB
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 years at the time of signing the informed consent form
- Fulfil at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR)
Present with active SLE disease with at least one of the following symptoms:
i) Arthritis - > 2 joints with pain and signs of inflammation (i.e. tenderness, swelling, or effusion) ii) Inflammatory-type skin rash iii) Oral ulcers
Laboratory values as follows
- Hemoglobin ≥ 100 g/L
- Absolute neutrophil count ≥ 1.0 x 109/L
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST (SGOT) / ALT (SGPT) ≤ 2.5 x ULN
- Ability to take and retain oral medication
- Ability to sign and date a written informed consent prior to entering the study
- Willingness and ability to comply with the protocol for the duration of the study
Exclusion Criteria:
- Active severe SLE flare with central nervous system (CNS) manifestations, active renal lupus, systemic vasculitis, active pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol.
- Severe renal impairment (estimated or measured GFR <50%)
- Oral treatment with corticosteroids (>15 mg/day prednisolone or equivalent) or changes in corticosteroid dosing within 30 days prior to the first dose of study medication. This also includes intraarticular steroid injections or topical treatment for SLE symptoms. Inhaled or topical steroids may be given for reasons other than SLE disease activity (such as asthma, contact dermatitis) as clinically indicated.
- Intravenous corticosteroids within 3 months prior to the first dose of study medication.
- Intravenous cyclophosphamide within 6 months prior to the first dose of study medication.
- Treatment with anti-rheumatic/immunosuppressive drugs within 3 months prior to first dose of study medication, other than the following medications at stable doses: methotrexate (≤25 mg/week), azathioprine (≤2.5 mg/kg/day), hydroxychloroquine and mycophenolate mofetil (≤3000 mg/day).
- B-cell depletion therapy (such as treatment with Rituximab) within 12 months prior to the first dose of study medication.
- Potent inhibitors or inducers of CYP3A4 intravenously or orally within 14 days prior to first dose of study medication.
- History of myocardial infarction or current uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia.
- Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 milliseconds
- History of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome)
- Treatment with concomitant medications that prolong the QT interval.
- History of, or current, ischemic CNS disease.
- Current malignancy. A 5-year cancer-free period is required with the exception of skin basal or squamous cell carcinoma or cervical cancer in situ that has been excised.
- Current severe infection
- Positive result on screening for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) antibodies.
- Drug abuse.
- Major surgery within 3 weeks prior to study entry.
- Known or suspected hypersensitivity to ABR-215757 or excipients.
- Female subject of child-bearing potential who is not using a medically accepted safe method of contraception. All female subjects of child-bearing potential must have a negative urine pregnancy test at the Screening and Baseline Visits. As interaction studies between ABR-215757 and oral contraceptives have not yet been performed, women using the contraceptive pill must also use a complementary contraceptive device, i.e. barrier method, during the treatment period and for at least 1 month thereafter.
- Female subject of child-bearing potential who is pregnant or lactating.
- Simultaneous participation or participation within 4 months or 5 half lives (whichever is longer) prior to study entry in any other study involving investigational drugs or other experimental therapy.
- Other significant, unstable medical disease not related to SLE that in the investigator's opinion would confound the study result or put the patient at risk.
- Patients likely to receive oral or intravenous steroids or immunosuppressant for other non-SLE condition during the study duration, as this will confound the study result.
- Vaccination within 4 weeks prior to the first dose of study medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in disease activity and biomarkers in patients with mild active SLE treated with ABR-215757
Time Frame: Patients will be treated for 12 weeks with ABR-215757. During treatment there will be scheduled visits on days 14, 28, 56 and 84. Follow-up visits will take place 29 days and 57 days after last dose of ABR-215757
|
Patients will be treated for 12 weeks with ABR-215757. During treatment there will be scheduled visits on days 14, 28, 56 and 84. Follow-up visits will take place 29 days and 57 days after last dose of ABR-215757
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety and tolerability of ABR-215757 in SLE patients with mild active disease. To assess plasma levels of ABR-215757 during the study
Time Frame: Patients will be treated for 12 weeks with ABR-215757. During treatment there will be scheduled visits on days 14, 28, 56 and 84. Follow-up visits will take place 29 days and 57 days after last dose of ABR-215757
|
Patients will be treated for 12 weeks with ABR-215757. During treatment there will be scheduled visits on days 14, 28, 56 and 84. Follow-up visits will take place 29 days and 57 days after last dose of ABR-215757
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Marie Wallén Öhman, Ph.D., Active Biotech AB
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
September 1, 2010
Study Registration Dates
First Submitted
October 16, 2009
First Submitted That Met QC Criteria
October 16, 2009
First Posted (ESTIMATE)
October 19, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 25, 2015
Last Update Submitted That Met QC Criteria
June 24, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09575704
- 2009-011245-55 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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