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

Completed · Not applicable · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus (SLE)

In brief

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

Key facts

Study ID

NCT03626311

Run by

Aker BioMarine Human Ingredients AS

People needed

76

Starts

2018-10-23

Expected to finish

2021-08-21

Last updated by the study team

2021-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged at least 18 years old.
• Capable of giving written consent on an Institutional Review Board or IRB-approved Informed Consent Form prior to any study-specific evaluation
• 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
• SLE activity (SLEDAI ≥6)
• 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):
• Corticosteroids. Corticosteroids (< 20 mg prednisone or equivalent per day)
• Hydroxychloroquine or equivalent anti-malarial
• 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)
• Belimumab dose must be stable for 60 days prior to Baseline
• Cyclophosphamide dose must be stable for the last 90 days prior to Baseline
• Have not received rituximab within 6 months
• 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.

You may not qualify if…

• Patients are excluded from the study if any of the following criteria are met:
• Have rapidly progressive neurologic or renal disease
• Currently taking an omega-3 prescription drug (e.g. Lovaza®, Vascepa®, etc.) or as medical food (e.g. Vascazen®, Vayarin, Onemia™etc.)
• 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 (e.g.,MegaRed)
• 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)
• 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
• Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
• Require anti-coagulation with coumadin, clopidogrel, dalteparin, dypyridamole, enoxaparin, heparin or ticlopidine. Low dose aspirin (<325 mg/day) is permitted.
• Receiving orlistat (Xenical, Alli) and have refused to discontinue at baseline and throughout the trial.
• History of allergy to seafood or shellfish
• Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
• Are pregnant or lactating
• 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
• Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity Grading Tables (CTCAE), except for the following that are allowed:
• Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy
• Stable Grade 3 hypoalbuminemia due to chronic lupus nephritis, and not related to liver disease
• 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.
• Stable Grade 3 neutropenia or stable Grade 3 white blood cell count due to lupus.
• Patients will be excluded from the study based on the following bone marrow, hepatic and renal function values:
• Hemoglobin: < 8.0 gm/dL
• Platelets: <50,000/mm
• ANC < 1.0 x 103/mm
• AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.
• Creatinine clearance ≤ 25ml/min per 1.73m2

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Wallace Rheumatic Studies Center, LLC — Beverly Hills, California, United States
• UC Irvine Health — Orange, California, United States
• University of Miami — Miami, Florida, United States
• Rush Medical Center — Chicago, Illinois, United States
• University of Maryland — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Northwell Health — Great Neck, New York, United States
• Feinstein Institute for Medical Research — Manhasset, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Lupus Clinic-Mary Pack Arthritis Centre — Vancouver, British Columbia, Canada
• McMaster University Medical Center — Hamilton, Ontario, Canada
• McGill University Health Centre-The Montreal General Hospital — Montreal, Quebec, Canada
• University of Laval — Québec, Canada

Full record on ClinicalTrials.gov

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