Systemic Lupus Erythematosus (SLE)ORKIDSNCT03626311
Omega-3 Replacement With Krill Oil in Disease Management of SLE
A study testing AKBM-3031 in people with Systemic Lupus Erythematosus (SLE), run by Aker BioMarine Human Ingredients AS at 19 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- AKBM-3031
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 23 Oct 2018to 21 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States15 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Maryland
Baltimore, Maryland, 21201
Wallace Rheumatic Studies Center, LLC
Beverly Hills, California, 90211
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Rush Medical Center
Chicago, Illinois, 60612
Northwell Health
Great Neck, New York, 11021
Feinstein Institute for Medical Research
Manhasset, New York, 11030
University of Miami
Miami, Florida, 33136
Hospital for Special Surgery
New York, New York, 10021
UC Irvine Health
Orange, California, 92868
Mayo Clinic
Rochester, Minnesota, 55902
University of Rochester Medical Center
Rochester, New York, 14642
Albert Einstein College of Medicine
The Bronx, New York, 10461
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Canada4 sites
McMaster University Medical Center
Hamilton, Ontario
McGill University Health Centre-The Montreal General Hospital
Montreal, Quebec
University of Laval
Québec
Lupus Clinic-Mary Pack Arthritis Centre
Vancouver, British Columbia
About this study
Official title: 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
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- AKBM-3031, Placebo
- Keywords
- Lupus, SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKBM-3031Dietary supplement
Also called Krill Oil
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AKBM-3031 | Experimental | 4g/day (2 capsules BID) Receives: Dietary Supplement: AKBM-3031 |
| Placebo | Placebo comparator | 4g/day (2 capsules BID) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 24 weeks
Secondary outcomes (4)
Effect of correction of omega-3 deficiency measured by SLE biomarkers of immune function.
Measured: Baseline to 24 weeks
Effect of correction of omega-3 deficiency measured by both clinician and patient reported outcomes collected at clinic visits.
Measured: Baseline to 24 weeks
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.
Measured: Baseline to 24 weeks
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).
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start23 Oct 2018
- Primary completion21 Aug 2021
- Study completion21 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aker BioMarine Human Ingredients AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ampel BioSolutions, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626311
- Sponsor's protocol ID
- AMP-004
- Acronym
- ORKIDS
- Status last verified
- Oct 2021
- First submitted
- 6 Jun 2018
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39009356
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03626311
- Acronym / sponsor ID
- ORKIDS / AMP-004
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- Lupus, SLE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Aker BioMarine Human Ingredients ASIndustry (pharma, biotech, devices)
- Collaborators
- Ampel BioSolutions, LLC
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 21 Aug 2021 (actual)
- Study completion
- 21 Aug 2021 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AKBM-3031 | Experimental | Dietary Supplement: AKBM-30314g/day (2 capsules BID) |
| Placebo | Placebo comparator | Other: Placebo4g/day (2 capsules BID) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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):
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKBM-3031Also: Krill OilKrill 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. | Dietary supplement | AKBM-3031 |
| PlaceboThe 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. | Other | Placebo |
Primary outcome
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.
Time frame: Baseline to 24 weeks
4 secondary outcomes
Effect of correction of omega-3 deficiency measured by SLE biomarkers of immune function.
Time frame: Baseline to 24 weeks
Effect of correction of omega-3 deficiency measured by both clinician and patient reported outcomes collected at clinic visits.
Time frame: Baseline to 24 weeks
Change in health related quality of life measured using the Medical Outcomes study Short Form 36 (SF-36).
Time frame: Baseline to 24 weeks
Difference of number of patients with reported adverse events or changes in lab parameters while taking AKBM-3031.
Time frame: Baseline to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 39009356Salmon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKBM-3031 in people with Systemic Lupus Erythematosus (SLE), run by Aker BioMarine Human Ingredients AS at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03626311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.