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

NCT03626311 | Completed DMC

• 1 other identifier: AMP-004
• Study Type: interventional
• Target: 76
• Locations: 2 countries
• Sites: 19

Brief Summary

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

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

Lupus; SLE

Outcome Measures

Primary Outcomes (1)

• Difference in the ratio of omega-3 to omega-6 measured through lab tests on red blood cells from baseline through the end of the study in patients with generalized lupus.

  Baseline to 24 weeks

Secondary Outcomes (4)

• Effect of correction of omega-3 deficiency measured by SLE biomarkers of immune function.

  Baseline to 24 weeks

• Effect of correction of omega-3 deficiency measured by both clinician and patient reported outcomes collected at clinic visits.

  Baseline to 24 weeks

• Change in health related quality of life measured using the Medical Outcomes study Short Form 36 (SF-36).

  Baseline to 24 weeks

• Difference of number of patients with reported adverse events or changes in lab parameters while taking AKBM-3031.

  Baseline to 24 weeks

Study Arms (2)

AKBM-3031

EXPERIMENTAL

4g/day (2 capsules BID)

Dietary Supplement: AKBM-3031

Placebo

PLACEBO COMPARATOR

4g/day (2 capsules BID)

Other: Placebo

Interventions

AKBM-3031 DIETARY_SUPPLEMENT

Krill are shrimp-like small crustaceans (up to 6 cm) found in all the world's oceans, but mostly in the Arctic and Antarctic polar seas. Krill are rich in the long-chain omega-3 polyunsaturated fatty acids or LC-PUFAs eicosapentaenoic acid (EPA, C20:5n3) and docosahexaenoic acid (DHA, C22:6n3). The lipid pool of krill is composed of phospholipids and triglycerides and the LC-PUFAs are primarily in the phospholipid fraction. The product is produced under food Good Manufacturing Practice (GMP) regulations and has status as GRAS or Generally Recognized As Safe. GRAS is defined by the US Food and Drug Administration (FDA) as a substance that is generally recognized, among qualified experts, to be safe under the conditions of its intended use.

Also known as: Krill Oil

AKBM-3031

Placebo OTHER

The placebo will be provided in capsules looking exactly as the krill oil capsules and will contain a fatty acid mixture (olive oil, corn oil, palm oil and medium chain triglycerides) which has the same composition as the average European diet (26.0% C16:0, 4.6% C18:0, 35.8% C18:1n9, 16.7% C18:2n6, 2.1% C18:3n3, 0% C20:4n6 and 14.8% other compounds) and contains no EPA or DHA.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Aker BioMarine Human Ingredients AS: lead
• Ampel BioSolutions, LLC: collaborator

Study Sites (19)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Wallace Rheumatic Studies Center, LLC

Beverly Hills, California, 90211, United States

Location

UC Irvine Health

Orange, California, 92868, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Rush Medical Center

Chicago, Illinois, 60612, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Lupus Clinic-Mary Pack Arthritis Centre

Vancouver, British Columbia, Canada

Location

McMaster University Medical Center

Hamilton, Ontario, Canada

Location

McGill University Health Centre-The Montreal General Hospital

Montreal, Quebec, Canada

Location

University of Laval

Québec, Canada

Location

Related Publications (1)

• Salmon J, Wallace DJ, Rus V, Cox A, Dykas C, Williams B, Ding Y, Hals PA, Johnsen L, Lipsky PE. Correction of omega-3 fatty acid deficiency and improvement in disease activity in patients with systemic lupus erythematosus treated with krill oil concentrate: a multicentre, randomised, double-blind, placebo-controlled trial. Lupus Sci Med. 2024 Jul 14;11(2):e001201. doi: 10.1136/lupus-2024-001201.

  PMID: 39009356 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomized (1:1) to receive either AKBM-3031 or placebo during the randomized period.The randomized subjects will take (4)1 gram capsules of product or placebo every day, (2) 1 gram capsules in the morning and (2) 1 gram capsules in the evening, for a total of 4 grams per day for the first 24 weeks (randomized period). All subjects may continue to a 24-week extension (Open Label Extension) of open-label AKBM-3031, 4 grams/day. The total study duration per subject is 48 weeks. With about 4 months for site activation and 12 months for enrollment, the entire study is expected to complete in approximately 116 weeks.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: August 13, 2018
• Study Start: October 23, 2018
• Primary Completion: August 21, 2021
• Study Completion: August 21, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

US (15); CA (4)