Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Systemic Lupus Erythematosus,covid-19
• Age: Between 18 years - 70 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Subjects who fulfill the updated ACR 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus
  2. Male and Female subjects between 18 and 70 years
  3. Subjects with at least 3 months treatment with an anti-malarial drug such as hydroxychloroquine or a history of intolerance, contraindication, or unwillingness to take an anti-malarial drug
  4. Subjects who are able to undergo neuroimaging data collection procedures
  5. Subjects who meets the SELENA SLEDAI definition of arthritis or mild/moderate arthritis or tendonitis scored as a BILAG B on the updated BILAG 2004
  6. Seven-day average of maximum of daily pain NRS scores = 4 out of 10
  7. Subjects who overlap with polymyositis, systemic sclerosis, Sjögren’s syndrome, or rheumatoid arthritis is allowed, if, in the site investigator’s judgment, the predominant clinical features are those of SLE
  8. Subjects who are not expected by the site investigator to require a change in potential disease-modifying treatments for SLE from Screening through Visit 6
  9. Subjects willing to not start or stop any NSAIDs or potential disease-modifying medications or supplements for SLE from Screening through Visit 6, unless a change is recommended by the site investigator or other treating physicians
  10. Subjects willing not to use any legal or illegal cannabinoids, including FDA-approved cannabinoids or cannabinoid-mimic drugs, or any illegal substance of abuse from Screening through Visit 6
  11. Female subjects of child-bearing potential who are willing to use one of the highly effective birth control method from Screening through Visit 6 or for 28 ± 3 days after the last dose of study product
  12. Subjects who are willing to follow instructions, complete study procedures and attend study visits as required by this protocol

  
  

You may not be eligible for this study if the following are true:

• 1. Subjects with severe or unstable SLE
  2. Subjects with significant diseases or conditions other than SLE that may influence response to the study product or safety
  3. Subjects with history of chronic pain requiring treatment with narcotic analgesia for more than 14 days total within 6 months of baseline
  4. Subjects who currently have evidence of alcohol abuse or history of abuse of illegal and/or legally prescribed drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, or opioids during the 1 year prior to Screening
  5. Subjects who are currently pregnant, breast-feeding, or lactating
  6. Subjects who had any investigational agent within 30 days or five therapeutic half-lives of that agent whichever is longer, before Visit 1
  7. Subjects with specific laboratory tests as listed in protocol at time of Screening
  8. Subjects with any other conditions that, in the opinion of the site investigator, are clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.