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Systemic Lupus ErythematosusPhase 2NCT00997100

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

A Phase 2 study testing paquinimod (ABR-215757) in people with Systemic Lupus Erythematosus, run by Active Biotech AB at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
paquinimod (ABR-215757)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
4 sitesin 2 countries
Study dates
Aug 2009to Sep 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
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  • 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

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Sweden3 sites

  • Dept of Rheumatology, University Hospital in Lund

    Lund, Lund, 220 07

  • Iva Gunnarsson M.D.

    Stockholm, Stockholm County, 171 76

  • Lars Rönnblom M.D.

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Denmark1 site

  • Soren Jacobsen

    Copenhagen, Copenhagen, 2100

Other trials in Denmark

About this study

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)

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.

Read the 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.

Being tested
paquinimod (ABR-215757)
Keywords
Systemic Lupus Erythematosus (SLE), ABR-215757, Change in Biomarkers
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paquinimod (ABR-215757)Drug

    Also called ABR-215757, paquinimod

    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

Study groups in NCT00997100
Study groupRoleWhat they receive
ABR-215757OtherNot described
Receives: Drug: paquinimod (ABR-215757)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in disease activity and biomarkers in patients with mild active SLE treated with ABR-215757

    Measured: 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 outcomes (1)

  1. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00997100
Sponsor's protocol ID
09575704
Other IDs
2009-011245-55, 2009
Status last verified
Jun 2015
First submitted
16 Oct 2009
Last updated
25 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing paquinimod (ABR-215757) in people with Systemic Lupus Erythematosus, run by Active Biotech AB at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00997100.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.

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