Omega-3 Replacement With Krill Oil in Disease Management of SLE

Therapuetic Areas:Immunology / Infectious Diseases
Age Range:18 - Any
Start Date:December 2018
End Date:February 2021
Contact:Claire Dykas

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A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE)

A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031or
placebo for 24 weeks (randomized period) and followed by an open label extension (OLE)
treatment with AKBM-3031 for the next 24 weeks. Patients will be maintained on stable doses
of background medications, except for glucocorticoids. Decreases in doses of glucocorticoids
will be encouraged during the first 20 weeks of both the randomized and open label extension
portions of the trial. Stable doses of glucocorticoids and other background medications are
required during weeks 20-22 and 44-48.If indicated by the PI, brief increases in
corticosteroids are permitted during the first 20 weeks of both the blinded and open label
extension portion of the trial. The increase in prednisone (or equivalent) dose is limited to
2X the back-ground level to a maximum of20 mg/day for a maximum of 1 week (7 days) or to a
single administration of intravenous methylprednisolone or equivalent at a maximum dose of
500mg. Stable doses of glucocorticoids and other background medications are required during
weeks 20-22 and 44-48

Inclusion Criteria:

1. Male or female aged at least 18 years old.

2. Capable of giving written consent on an Institutional Review Board or IRB-approved
Informed Consent Form prior to any study-specific evaluation

3. Have a clinical diagnosis of SLE with at least 4 of the 11 American College of
Rheumatology (ACR) criteria as modified in 1997 or meeting SLICC criteria

4. SLE activity (SLEDAI ≥6)

5. On a stable SLE treatment regimen consisting of a stable dosage of any of the
following medications for a period of at least 30 days prior to Baseline (i.e., day of
1st dose of study agent):

1. Corticosteroids. Corticosteroids (< 20 mg prednisone or equivalent per day)

2. Hydroxychloroquine or equivalent anti-malarial

3. Other immunosuppressive or immunomodulatory agents including methotrexate,
azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil,
mycophenolate mofetil hydrochloride, and mycophenolate sodium at no more than 2
grams/day), calcineurin inhibitors (e.g., tacrolimus,cyclosporine)

4. Belimumab dose must be stable for 60 days prior to Baseline

5. Cyclophosphamide dose must be stable for the last 90 days prior to Baseline

6. Have not received rituximab within 6 months

6. Have a low habitual consumption of fatty fish and seafood, defined as a frequency of
twice per month or less; see Addendum 1 for a list of fish and seafood considered to
be fatty.

Exclusion Criteria:

Patients are excluded from the study if any of the following criteria are met:

1. Have rapidly progressive neurologic or renal disease

2. Currently taking an omega-3 prescription drug (e.g. Lovaza®, Vascepa®, etc.) or as
medical food (e.g. Vascazen®, Vayarin, Onemia™etc.)

3. Present or recent use (within 3 months of screening) of any OTC fish or krill oil
dietary supplement., or any long-chain omega-3 fatty acid dietary supplement

4. Have severe lupus kidney disease (defined by proteinuria > 6 gm/24 hour or equivalent
using spot urine protein to creatinine ratio, or serum creatinine > 2.5mg/dL)

5. Have clinical evidence of significant unstable or uncontrolled acute or chronic
diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic,
gastrointestinal, neurological, or infectious) which, in the opinion of the treating
physician, could confound the results of the study or put the patients at undue risk

6. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the
past month

7. Require anti-coagulation with coumadin, clopidogrel, dalteparin, dypyridamole,
enoxaparin, heparin or ticlopidine. Low dose aspirin (<325 mg/day) is permitted.

8. Receiving orlistat (Xenical, Alli) and have refused to discontinue at baseline and
throughout the trial.

9. History of allergy to seafood or shellfish

10. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol
abuse or dependence within 364 days prior to Baseline

11. Are pregnant or lactating

12. Recent participation in a clinical trial with an experimental agent in the past 6
weeks, or 5 half-lives of the study drug, whichever is longer

13. Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity
Grading Tables (CTCAE), except for the following that are allowed:

1. Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and
not related to liver disease or anti-coagulant therapy

2. Stable Grade 3 hypoalbuminemia due to chronic lupus nephritis, and not related to
liver disease

3. Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis,
and not related to alcoholic liver disease, uncontrolled diabetes, or viral
hepatitis. If present, any abnormalities in the ALT or Alanine Transaminase
and/or AST or Aspartate Transaminase must be < Grade 2.

4. Stable Grade 3 neutropenia or stable Grade 3 white blood cell count due to lupus.

14. Patients will be excluded from the study based on the following bone marrow, hepatic
and renal function values:

1. Hemoglobin: < 8.0 gm/dL

2. Platelets: <50,000/mm

3. ANC < 1.0 x 103/mm

4. AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.

5. Creatinine clearance ≤ 25ml/min per 1.73m2
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