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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03626311
Other study ID # AMP-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 23, 2018
Est. completion date August 21, 2021

Study information

Verified date October 2021
Source Aker Biomarine Antarctic AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date August 21, 2021
Est. primary completion date August 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 (e.g.,MegaRed) 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
AKBM-3031
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.
Other:
Placebo
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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Aker Biomarine Antarctic AS Ampel BioSolutions, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Effect of correction of omega-3 deficiency measured by SLE biomarkers of immune function. Baseline to 24 weeks
Secondary Effect of correction of omega-3 deficiency measured by both clinician and patient reported outcomes collected at clinic visits. Baseline to 24 weeks
Secondary Change in health related quality of life measured using the Medical Outcomes study Short Form 36 (SF-36). Both physical component scores (PCS) and mental component scores (MCS) will be assessed. Change in both PCS and MCS will be evaluated over the time of this study. The SF-36 is a patient recorded survey of health related quality of life, consisting of the evaluation of 8 domains, and then scored from 0-100. The higher score correlates to better health-related quality of life. The mean for healthy individuals is 50. Baseline to 24 weeks
Secondary Difference of number of patients with reported adverse events or changes in lab parameters while taking AKBM-3031. Examples of patient reported adverse events include gastrointestinal symptoms, infection, unexplained bleeding, etc. Examples of lab parameters indicating an adverse event are changes in liver function tests, urinalysis, and hematologic parameters (which could be considered an adverse event). Baseline to 24 weeks
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