JBT-101 in Systemic Lupus Erythematosus (SLE)

Inclusion Criteria

• Fulfills the updated American College of Rheumatology (ACR) 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus;
• At least 3 months of treatment with an anti-malarial drug such as hydroxychloroquine or a history of intolerance, contraindication, or unwillingness to take an anti-malarial drug;
• Meets the Safety of Estrogen in Lupus: National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) definition of arthritis (Petri et al., 1999) or mild/moderate arthritis or tendonitis scored as a BILAG B on the updated BILAG 2004;
• Seven-day average of maximum of daily pain Numerical Rating Scale (NRS) scores ≥ 4 out of 10;
• 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 Systemic Lupus Erythematosus (SLE);
• Not expected by the site investigator to require a change in potential disease- modifying treatments for SLE from Screening through Visit 6 (Day 112);
• Willing to not start nor stop any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or potential disease-modifying medications or supplements for SLE from Screening through Visit 6 (Day 112), unless a change is recommended by the site investigator or other treating physicians;
• Willing not to use any legal or illegal cannabinoids, including Food and Drug Administration (FDA)-approved cannabinoids or cannabinoid-mimic drugs, or any illegal substance of abuse from Screening through Visit 6 (Day 112);
• If a woman of child-bearing potential, willing to use one of the highly effective (failure rate 10 mg per day or > 20 mg every other day (or equivalent dose of another corticosteroid) within 14 days of Screening;
• Increased dose of systemic corticosteroids in the 14 days prior to Screening;
• Treatment with cyclophosphamide or anti-TNFalpha biologic agents within 3 months before Visit 1 (Day 1);
• Treatment with B cell-depleting monoclonal antibodies (rituximab, Ocrelizumab, anti-CD22) within 6 months before Visit 1 (Day 1);
• Treatment with methotrexate, mycophenolate, azathioprine, leflunomide, cyclosporine, belimumab, tacrolimus, or any other immunosuppressive agent not included in 2b.-d. above, when the dose of that immunosuppressive agent has increased within 3 months before Visit 1. Concurrent treatment with any of these medications is allowed as long as the doses have been stable for at least 3 months before Visit 1 (Day 1); or
• Actively listed on an organ transplantation list or have received an organ transplant other than a corneal transplant.
• Significant diseases or conditions other than SLE that may influence response to the study product or safety, such as:
• Active bacterial or viral infection requiring systemic antibiotic or anti-viral treatment within 14 days before Visit 1 (Day 1);
• Acute or chronic hepatitis B or C infection;
• Human immunodeficiency infection (HIV);
• History of active tuberculosis or positive tuberculosis skin or blood test without: 1) completing a course of appropriate treatment; or ) having received at least one month of appropriate treatment prior to Visit 1 (Day 1) and continuing to receive appropriate treatment during the study;
• No elective surgery should be planned from Visit 1 (Day 1) through Visit 6 (Day 112); or
• A history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy greater than one year before Visit 1 (Day 1).
• Significant heart disease as defined by:
• Uncontrollable congestive heart failure, unstable angina, unstable atherosclerotic cardiovascular disease, significant arrhythmia requiring chronic therapy, pulmonary arterial hypertension with dyspnea, disability rated as New York heart Association Grade III or higher, severe systemic hypertension or severe peripheral vascular disease;
• Marked baseline prolongation of QT/QTc inter