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

Institutional Review Board, Hospital for Special Surgery

March 20, 2019

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Kyriakos A. Kirou, MD, DSc, FACP

Co-Investigators

David R. Fernandez, MD, PhD
Mary Peng

Summary

The main purpose of this research is to investigate whether treatment with Krill Phospholipids Concentrate (AKBM-3031), also known as Krill Oil, is able to replenish the omega-3 deficiency associated with Systemic Lupus Erythematosus (SLE). Omega-3 is an essential nutrient that is important in preventing and managing heart disease. In addition, this study is also being done to determine whether taking the Krill Oil has further positive effects in SLE patients with regards to slowing down the progression of and/or preventing disease flares. SLE is a disease that affects the immune system and can affect any part of the body (skin, joints, and/or organs).

Your participation in this research will last approximately 48 weeks. For the first 24 weeks of the study, eligible subjects will be randomly assigned in an equal ratio between either the placebo treatment group or the Krill Oil treatment group. These treatments will be taken in addition to your routine care and therapy. In the last 24 weeks of the study, all subjects will be placed on Krill Oil regardless of the treatment group they were previously assigned.

Study participation is voluntary. There will be a total of 8 clinic visits, including an eligibility screening visit, and 6 remote, phone visits. Each clinic visit will take approximately 2 hours and each phone visit approximately 10-25 minutes.

 

Inclusion/Exclusion Criteria

Someone CAN participate in this study if they meet the following:

• Male or female aged at least 18 years old
• Are capable of providing written consent to participate in the study
• Are diagnosed with Systemic Lupus Erythematosus (SLE)
• On a stable SLE treatment regimen consisting of any of the following medications for a period of at least 30 days:
• Corticosteroids < 20 mg prednisone or equivalent per day
• Hydroxychloroquine or equivalent anti-malarial
• Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate, tacrolimus, cyclosporine
• Belimumab dose must be stable for 60 days
• Cyclophosphamide dose must be stable for the last 90 days
• 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
• Are willing to perform and comply with all study procedures, including attending clinic visits as scheduled
• Agree to practice at least 1 approved method of contraception
   

Someone CANNOT participate in this study if they have the following:

• History of an allergy to seafood or shellfish
• Currently taking an omega-3 prescription drug or as medical food
• Present or recent use (within 3 months) of any over-the-counter fish or krill oil dietary supplement, or any long-chain omega-3 fatty acid dietary supplement
• Are pregnant or lactating
• Recent participation in a clinical trial with an experimental agent in the past 6 weeks
• Have rapidly progressive neurologic disease or renal disease
• Require anti-coagulation with Coumadin, clopidogrel, dalteparin, dypyridamole, enoxaparin, heparin or ticlopidine. Low dose aspirin (< 325 mg/day) is permitted
• Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month

Contact Information

Mary Peng
Research Coordinator
pengm@hss.edu
212.774.2967