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Register:	EUCTR
Last refreshed on:	9 September 2013
Main ID:	EUCTR2009-011245-55-SE
Date of registration:	18/03/2009
Prospective Registration:	Yes
Primary sponsor:	Active Biotech Research AB
Public 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). Final Protocol dated 2009-03-16, Protocol Amendment 1 dated 2009-10-13, Protocol Amendment 2 dated 2009-12-02
Scientific 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). Final Protocol dated 2009-03-16, Protocol Amendment 1 dated 2009-10-13, Protocol Amendment 2 dated 2009-12-02
Date of first enrolment:	06/05/2009
Target sample size:	20
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011245-55
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Denmark	Sweden

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
1. Age > 18 years at the time of signing the informed consent form
2. Fulfil at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR).
3. 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
4. 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
5. Ability to take and retain oral medication
6. Ability to sign and date a written informed consent prior to entering the study
7. Willingness and ability to comply with the protocol for the duration of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subject Exclusion Criteria:
A patient will be excluded from participation in the study if one or more of the following statements are applicable:
1. 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.
2. Severe renal impairment (estimated or measured GFR <50%)
3. 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.
4. Intravenous corticosteroids within 3 months prior to the first dose of study medication.
5. Intravenous cyclophosphamide within 6 months prior to the first dose of study medication.
6. 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).
7. B-cell depletion therapy (such as treatment with Rituximab) within 12 months prior to the first dose of study medication.
8. Potent inhibitors or inducers of CYP3A4 intravenously or orally within 14 days prior to first dose of study medication.
9. 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.
10. Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 milliseconds
11. History of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome)
12. Treatment with concomitant medications that prolong the QT interval.
13. History of, or current, ischemic CNS disease.
14. 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.
15. Current severe infection
16. Positive result on screening for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) antibodies.
17. Drug abuse.

18. Major surgery within 3 weeks prior to study entry.
19. Known or suspected hypersensitivity to ABR-215757 or excipients.
20. 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, ie barrier method, during the treatment period and for at least 1 month thereafter.
21. Female subject of child-bearing potential who is pregnant or lactating.
22. 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.
23. Other significant, unst

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus (SLE)

Intervention(s)

Product Name: ABR-215757
Product Code: ABR-215757
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: paquinimod
CAS Number: 248282-01-1
Current Sponsor code: ABR-215757
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-mg milligram(s)

Primary Outcome(s)

Main Objective: To assess changes in disease activity and biomarkers in patients with mild active SLE during treatment with ABR-215757.

Primary end point(s): Changes in disease activity and biomarkers in patients with mild active SLE treated with ABR-215757.

Secondary Objective: • To assess the safety and tolerability of ABR-215757 in patients with mild active SLE disease
• To assess the plasma levels of ABR-215757 during the study.

Secondary Outcome(s)

Secondary ID(s)

09575704

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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